J Community Health DOI 10.1007/s10900-014-9820-3
ORIGINAL PAPER
Lifestyle Intervention and Cardiovascular Disease Risk Reduction in Low-Income Hispanic Immigrant Women Participating in the Illinois WISEWOMAN Program Manorama M. Khare • John F. Cursio • Cara A. Locklin • Nancy J. Bates • Ryan K. Loo
Ó Springer Science+Business Media New York 2014
Abstract Cardiovascular disease (CVD) is the leading cause of death for Hispanic women in the United States. In 2001, the Illinois Department of Public Health received funding from the Centers for Disease Control and Prevention to implement the enhanced WISEWOMAN program (IWP) to address the disproportionate CVD risk among uninsured and underinsured women enrolled in the Illinois Breast and Cervical Cancer Early Detection Program. This paper presents the results of the Spanish-language arm of the IWP. Spanish speaking IWP participants were recruited from two sites, and randomized into either the minimum intervention (MI) or the enhanced intervention (EI) group. Both groups received CVD risk factor screening and educational handouts. The EI group also received an integrated 12-week nutrition and physical activity lifestyle change
M. M. Khare (&) Division of Health Policy and Social Science Research, Department of Family and Community Medicine, University of Illinois College of Medicine at Rockford, 1601 Parkview Avenue, Rockford, IL 61107-1897, USA e-mail: [email protected] J. F. Cursio Center for Quality, University of Chicago Hospital, Chicago, IL, USA C. A. Locklin Center for Research on Women and Gender, University of Illinois at Chicago, Chicago, IL, USA N. J. Bates Center for Clinical and Translational Science, University of Illinois at Chicago, Chicago, IL, USA R. K. Loo Spectrum Health Policy Research, LLC, Lawrenceville, GA, USA
intervention. Of the 180 Spanish-speaking immigrants in this sample, 90 (50 %) received the EI and 90 (50 %) received the MI. At baseline there were no significant differences between group demographics or clinical values. At post-intervention, the EI group showed improvements in fat intake, fiber intake, moderate intensity physical activity, and total physical activity. At 1 year only the change in fiber intake remained. A significant improvement was also seen in body mass index (BMI) at the 1-year follow-up. The IWP Spanish-language arm was moderately successful in addressing risk factors for CVD in this population. The behavior changes that sustained up to a year were an increase in fiber intake and a decrease in BMI. Keywords Cardiovascular health Physical activity Nutrition Hispanic
Introduction Cardiovascular disease (CVD) is the leading cause of death for Hispanic women in the United States, resulting in 29.6 % of deaths in 2009 [1, 2]. Numerous modifiable risk factors such as high dietary intake of fat and sodium, low dietary intake of fruits and vegetables, lack of physical activity, stress, alcohol consumption, and smoking are associated with an increased risk for CVD [3, 4]. Women of minority ethnic groups and low socioeconomic status (SES) are more likely to report these risk factors than white women and women of higher SES [5, 6]. Among Hispanic women, lower rates of physical activity may be influenced by traditional gender roles that encourage women to place domestic duties as first priority, leaving little personal time for physical activity [6, 7]. Hispanic immigrant women also report eating fewer fresh
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fruits and vegetables, and consuming more high-calorie meals at fast food restaurants in the United States than in their native countries [7, 8]. Because of these cultural factors, tailored interventions have been shown to be more effective at addressing CVD risk in Hispanic immigrant women [9, 10]. In 2001, the Illinois Department of Public Health (IDPH) received funding from the Centers for Disease Control and Prevention (CDC) to implement the enhanced WISEWOMAN program (IWP). This program was designed to address the disproportionate CVD risk among women enrolled in the Illinois Breast and Cervical Cancer Early Detection Program (IBCCP). The IWP intervention was implemented with a total of 1,021 women, 833 who participated in the English-language arm and 188 who participated in the Spanish-language arm. Of the Spanish speakers, 180 reported being first generation immigrants. Results of the English language implementation have shown that IWP was effective in improving dietary and physical activity outcomes in the enhanced intervention (EI) group both at post-intervention and the 1-year followup. In this paper we report the results of the IWP for Spanish-speaking immigrant women and present the changes in dietary, physical activity and clinical indicators from baseline to post-intervention and 1-year follow-up. Our hypothesis was that participants in the EI group will have improved behavioral and clinical outcomes as compared to the participants in the minimum intervention (MI) group at post-intervention and the 1-year follow-up.
Methods The Illinois IWP was developed collaboratively among IDPH, the University of Illinois at Chicago’s (UIC) National Center for Excellence in Women’s Health, The Cooper Institute (CI), and CDC. The IWP study used a randomized two-group design to assess the effectiveness of the 12-week lifestyle change intervention in reducing CVD risk in underinsured or uninsured woman aged 40–64 years enrolled in the IBCCP program. The Western Institutional Review Board approved the project, and informed consent was obtained from all participants prior to enrollment in the IWP. The UIC Institutional Review Board approved the overall evaluation of this project. IWP recruited IBCCP participants for the Spanish-language arm from two sites. Women who chose to participate were randomized into either the MI or the EI group. Participants were informed of their assignments via phone. Participants in both the MI and EI group received CVD risk factor screening; CVD-related educational handouts from the American Heart Association and the National Institutes of Health; referrals for physician care as needed; follow-up
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assessments at one and 2 years from baseline; and postcards and newsletters. In addition, the EI group received a 12-week lifestyle change intervention. Demographic information, a health history assessment that identified women who needed medical clearance to participate in the program, behavioral assessments, an acculturation scale and clinical measures were collected at baseline. Behavioral assessments and clinical measures were also collected at post-intervention, and one and 2 years from baseline. The IWP design, curriculum and methods are described in greater detail elsewhere [11–14]. IWP Curriculum The IWP curriculum was designed by CI in collaboration with IDPH and UIC by adapting its evidence-based nutrition and physical activity curricula to the target population [15, 16]. These curricula are based on the constructs of the Social Cognitive Theory (SCT) [17] and the Transtheoretical Model [18]. Further details about the IWP curriculum have been reported elsewhere [13]. Pilot testing of both the English and Spanish language IWP curriculum showed that the materials were at too high a reading level for the participants and there was excessive content in each session. The IWP team worked with a literacy expert to modify the reading level of the materials to a 4th grade level, and the teaching was shifted from a pedagogical, didactic classroom approach to more of an interactive, andragogical approach [19] that emphasized group discussions, games, and team competitions. Details about the curriculum have been published earlier [13]. To develop a Spanish version of the IWP curriculum a rigorous process of translation and back-translation was used. The first translator did a universal translation, for all of Latin America with a focus on Mexico and Central America, since our target population was primarily from these regions. Another translator back-translated the Spanish curriculum to English. To ensure equivalency and consistency between the two curricula the curriculum developers reviewed the version back-translated to English for incorrect or discrepant materials and worked with the back translator to correct these discrepancies. At the time it was implemented, the IWP was the only WISEWOMAN program in the country to offer a Spanish curriculum. The Spanish-language IWP intervention was pilot tested with a total of 29 participants who were randomized into the EI and MI groups. The primary objective was to test the curriculum and education materials for appropriateness in the target population and to evaluate both process and outcome measures. The process evaluation identified issues related to recruitment methods, transportation, and lack of family support as barriers to the success of the intervention. These issues were addressed in the full-implementation of
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the Spanish-language IWP. An orientation session that included family members was added to the Spanish-language program, as support from families was found to be a critical factor in continued participation for this population. This addition of an orientation session was unique to the Spanish implementation of the program. Behavioral Measures Self-reported responses to validated nutrition and physical activity scales were used to assess the health behaviors of participants. The Fat and Fiber Questionnaire (FAFQ) [20] and the National Cancer Institute All Day Fruit and Vegetable Screener (FVS) [21] were the nutrition measures used. The FAFQ produces summary scores for fat and fiber intake and assesses eating behaviors related to choosing and preparing low-fat and high-fiber diets. The instrument uses a four point scale, where lower total scores indicate healthier eating habits. The FAFQ is a modified version of the Eating Patterns Questionnaire reported in Shannon et al. [21]. Modification included adding Latino foods and food preparation methods, accommodating language differences among Latinos from Mexico, Puerto Rico and Central America and translation/back translation into Spanish [22]. The FVS determines average number of fruit and vegetable servings consumed per day. Physical activity was assessed using a questionnaire from the Community Healthy Activities Model Program for Seniors (CHAMPS) [23]. The two summary scores from the CHAMPS survey used in this analysis were hours per week engaged in ‘‘all physical activity’’ and hours per week engaged in ‘‘moderate intensity activity’’. Clinical Measures Height and weight were collected to compute body mass index (BMI). Additional clinical measures included blood pressure, lipid counts (total cholesterol and LDL cholesterol), and blood glucose levels. Data Analysis Data were collected at individual sites and entered into the State of Illinois data system by the coordinators at each site. Data were electronically transferred to a secure server at University of Illinois at Chicago. Demographic characteristics of the EI and MI groups were compared at baseline using independent t-tests for age and Chi square statistics for race, education, and acculturation. Acculturation was measured using questions from the Marin Short Acculturation Scale [24]. Analysis of variance (ANOVA) was used to compare mean scale scores between the EI and MI groups for the FAFQ, FVS, and CHAMPS at each time
point. Chi squared analysis was used to compare attrition rates between groups. Completer to non-completer comparisons were conducted within each treatment group to determine if any characteristics were associated with attrition. Participants who attended the post-intervention appointment and completed the assessments were labeled as study completers, and those who did not complete the assessments were labeled as non-completers. The primary outcome measures in this analysis include: the FAFQ fat summary scale score; the FAFQ fiber summary scale score; the FVS score (total intake of fruit and vegetable servings per day); the CHAMPS all intensity physical activity; the CHAMPS moderate intensity physical activity; and clinical measures of total cholesterol, total glucose, LDL cholesterol and BMI. Changes over time within each intervention group were assessed using ANOVA. ANOVAs were conducted separately for each outcome measure using age, education, and intervention group (EI or MI) as independent variables. Effect sizes were calculated using Cohen’s d-statistic [25], which describes the magnitude of the difference between the mean score for each group at specific time points. Intent-totreat (ITT) analysis was conducted to present the hypothetical effect size for all participants assigned to the intervention, including those who dropped out. Statistical analysis was conducted using IBM SPSS Statistics v. 21 [26].
Results Sample Description Demographic characteristics of the sample are presented in Table 1. The 180 Spanish-speaking immigrants in this sample made up 17.6 % of the IBCCP participants recruited into the IWP; 90 (50 %) received the EI and 90 (50 %) received the MI. At baseline there were no significant differences between the EI and MI groups by age (p = 0.48), education (p = 0.49), or acculturation level (p = 0.97). The mean age of participants was 50.9 ± 6.9 years. Nearly twothirds of the participants (65.8 %) had no more than an eighth-grade education. Using questions from the Marin Short Acculturation Scale [24], participants had a mean acculturation score of 1.3 ± 0.6, indicating that the participants preferred Spanish over English for daily communication. The average amount of time spent living in the United States was 16.5 ± 10.9 years with a range of 1–55 years. Medical Referrals All participants completed a baseline health history and a clinical assessment prior to being randomized. Participants with abnormal levels of total blood cholesterol ([200 mg/dL),
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J Community Health Table 1 Demographic characteristics of participants at baseline by intervention group EI (n = 90)
MI (n = 90)
Total (n = 180)
p value
Mean age (mean ± SD)
51.23 ± 6.73
50.51 ± 7.04
50.87 ± 6.88
0.48
Age range (min, max)
40.39–64.64
40.06–64.61
40.06–64.64
Education, n (%)
0.49
B8th grade
54 (70.1)
48 (61.5)
9th–12th grade
18 (23.4)
22 (28.2)
40 (25.8)
C13 years
5 (6.5)
8 (10.3)
13 (8.4)
1.27 ± 0.61
1.27 ± 0.57
1.27 ± 0.59
58 (64.4)
59 (65.6)
117 (65.0)
Acculturation (mean ± SD)
102 (65.8)
Language acculturationa, n (%) Least acculturated (=1) Somewhat acculturated ([1 and B2) Most acculturated ([2) Years in US (mean ± SD)
0.97 0.29
30 (33.3)
25 (27.8)
55 (30.6)
2 (2.2) 16.93 ± 11.26
6 (6.7) 16.01 ± 10.52
8 (4.4) 16.47 ± 10.88
0.58
Independent t-tests were used for continuous variables and Chi square tests were used for categorical variables. No significant differences in baseline measures were seen between the EI and MI groups a
Scale of 1–5, where 1 is the least and 5 is the most acculturated
blood pressure ([140 mmHg systolic or [90 mmHg diastolic), or blood glucose ([125 mg/dL) were provided medical referrals but did not need written clearance from a physician to participate in the program. Participants with alert levels for any of these measures (total cholesterol [400 mg/ dL, systolic blood pressure [180 mmHg, diastolic blood pressure [110 mmHg, or blood glucose [375 mg/dL) were provided medical referrals and needed written permission from a physician to participate in the program. A total of 112 participants (62.2 %) had abnormal clinical values. Only one participant had an alert clinical value. Participants were also asked about their health history using a questionnaire. Written medical clearance was required if they indicated having problems involving the heart or joints, any other acute medical problems, or if a doctor had placed restrictions on their level of physical activity. Forty-eight participants (26.7 %) required written medical clearance based on positive responses to health history questions. All participants with alert values or positive health history obtained medical clearance and were randomized into the study. There were no significant differences between the EI and MI group for participants with alert values, or participants requiring medical clearance because of positive responses on the health history questionnaire. However, participants in the EI group (71.1 %) were significantly more likely to have abnormal clinical values that required a medical referral at baseline as compared to participants in the MI group (53.3 %) (v2 = 6.05, p = 0.01).
(30.0 %) attended between seven and eleven sessions, and another 27 (30.0 %) attended all twelve sessions. Attrition At post-intervention, 40 % of the EI participants had left the study as compared to 26.7 % of the MI participants (v2 = 3.6, p = 0.06). At baseline, there were no differences between completers and non-completers in age, education, acculturation, or number of years in the United States. When stratified by intervention group, there were no statistically significant differences between completers and non-completers in the MI group. However, completers within the EI group, had a lower education level (v2 = 7.79, p = 0.02), higher baseline total cholesterol levels (t = -2.00, p = 0.05), and fewer minutes of moderate physical activity levels at baseline (t = 2.02, p = 0.05). After 1 year, there was no significant difference in attrition rate for the EI (66.7 %) and MI (58.9 %) groups. Overall, those who completed the 1-year appointment had fewer minutes of total physical activity at baseline than non-completers (t = 3.58, p \ 0.01). In the EI group, those who completed the 1-year appointment had less total physical activity (p \ 0.01), higher systolic blood pressure (t = 2.96, p \ 0.01), and lower BMI (t = 2.09, p = 0.04) at baseline than the non-completers. In the MI group, those who completed the 1-year appointment were younger (t = 2.22, p = 0.03) and had a higher education level (v2 = 8.38, p = 0.02) than those who did not.
Session Attendance Primary Outcomes Attendance records for participants in the EI group show that 25 participants (27.8 %) did not attend any sessions, eleven (12.2 %) attended between one and six sessions, 27
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At baseline, there were no statistically significant differences between the EI and MI groups for any of the primary
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outcome measures (Table 2). Improvements in health behaviors were seen at post-intervention but not sustained at 1 year. Between-group comparisons at each time point for the fat and fiber summary scale scores showed no statistically significant differences at baseline, post-intervention, or the 1-year follow-up (Table 2). As seen in Table 3, participants within the EI group had statistically significant improvements in the dietary fat and dietary fiber summary scores from baseline to post-intervention (p = 0.01 and p = 0.01). At 1 year, the change in fiber score remained significant (p = 0.03), and the change in the fat score was marginally significant (p = 0.09). The MI group did not show improvement in either score at post-intervention or 1 year. Comparing the EI and MI groups at each time-point we found no statistically significant differences in the number of servings of fruits and vegetables consumed (Table 2). Intake of fruits and vegetables also did not differ within groups over time (Table 3). As seen in Table 2, there was no statistically significant difference in levels of total physical activity and moderate intensity physical activity between the EI and MI groups at any time-point. Participants in the EI group showed a statistically significant increase in both total physical activity (p \ 0.01) and moderate intensity physical activity (p \ 0.01) from baseline to post-intervention. However, at 1 year, levels were similar to baseline (Table 3). There was no change in physical activity levels for the MI group. Table 2 shows that at post-intervention, total blood cholesterol and LDL cholesterol were significantly lower for the MI group than the EI group (p = 0.02, p \ 0.01). However these differences did not sustain at the 1-year follow-up. As presented in Table 3, none of the clinical measures changed significantly within the EI group over time. Diastolic blood pressure improved significantly for the MI group at post-intervention, but that change was not maintained at 1 year. At the 1-year follow-up, however, BMI for the EI group was 1.81 units lower than that of the MI group (p = 0.03) and decreased gradually in the EI from baseline to 1-year for a loss of 2.64 units (p = 0.06). Effect Size Analysis Table 4 presents the results of the effect size analysis for the fat and fiber scores, servings of fruit and vegetables, physical activity measures, and clinical measures by treatment group at post-intervention and 1-year follow-up visits. The effect size reflects the standardized differences between the treatment group means at baseline and the follow-up visit and is based on Cohen’s d-statistic formula [25]. All analyses were done using the ITT principle. At the post-intervention visit, the largest effect sizes were seen for
levels of all physical activity (d = 0.64) and moderate intensity activity (d = 0.71) in the EI group. These effect sizes were larger than those seen in the MI group. Effect sizes for the fat (d = -0.43) and fiber (d = -0.52) summary scale scores were also moderate to strong in the EI group. Moderate effect sizes were seen in systolic blood pressure (d = -0.35) and diastolic blood pressure (d = -0.48) for the MI group at post-intervention. At the 1-year follow-up, moderate effect sizes were seen in dietary fiber (d = -0.46), moderate intensity activity (d = 0.30), systolic blood pressure (d = -0.47), and BMI (d = -0.34) in the EI group. A moderate effect size in blood glucose (d = -0.36) was seen in the MI group. Negative effect sizes for the fat and fiber summary scale scores indicate an improvement in fat and fiber related behaviors.
Discussion The IWP proved to be moderately effective at improving some risk factors for CVD in Spanish speaking immigrant women. Participants in the EI group showed positive changes in diet and physical activity outcomes at postintervention. At 1 year they maintained an increase in dietary fiber intake and had improved BMI levels. Participants in the EI group significantly improved their fat and fiber summary scale scores at post-intervention and maintained the increased fiber intake at 1 year. Effect size analysis showed that the actual size of the change in fiber scores was large, although decreasing slightly at 1 year (Table 4), and the change in dietary fat summary score at post-intervention was moderate. Fat and fiber changes in the Spanish speaking population were smaller than in the English speaking sample [11]. IWP participants were more successful in increasing fiber consumption than in reducing fat consumption. This suggests that it was easier for participants to include new, healthy foods into their diet than to restrict foods they are accustomed to eating. For example, tips to increase fiber intake included adding more beans and whole grains to recipes, substituting part of the flour in a baking recipe with whole wheat flour, choosing whole grain breads by reading labels. Tips to reduce fat intake included substituting leaner cuts of meat in recipes, substituting butter with oil, and using lower fat salad dressings which may be harder practices to change. In addition, intake of fruits and vegetables did not change significantly in the EI group. However, participants in both groups were already eating approximately the recommended five servings of fruits and vegetables per day at baseline, and they maintained similar intake throughout the study. They may have realized that their intake was adequate, and therefore did not attempt to increase it. This also
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2.57 ± 0.53
F = 0.33, p = 0.57
Model significanceb
Dietary fiber
Model significanceb
F = 1.75, p = 0.19
1.91 ± 1.76
F = 0.58, p = 0.45
2.80 ± 1.54
F = 2.06, p = 0.15
Model significanceb
Fruit
Model significanceb
Vegetables
Model significanceb
F = 1.66, p = 0.20 31.80 ± 6.14
F = 3.66, p = 0.06
206.65 ± 42.34
F = 0.65, p = 0.42
124.14 ± 35.29
F = 1.06, p = 0.31
115.09 ± 51.76
F = 0.72, p = 0.40
32.86 ± 6.40
F = 0.33, p = 0.57
Model significanceb
Total blood cholesterol
Model significanceb
LDL blood cholesterol
Model significanceb
Blood glucose (mg/dL)
Model significanceb
BMI (kg/m2)
Model significanceb
32.03 ± 6.83
108.76 ± 33.20
118.15 ± 36.47
201.23 ± 43.00
75.38 ± 8.61
73.21 ± 8.05
Blood pressure (diastolic)
b
31.17 ± 6.99
102.96 ± 26.51
108.85 ± 29.79
190.91 ± 37.72
72.15 ± 6.13
117.83 ± 11.20
4.41 ± 4.92
11.11 ± 7.74
2.90 ± 1.39
2.81 ± 2.70
5.70 ± 3.24
2.40 ± 0.69
2.27 ± 0.44
MI (n = 53) mean ± SD
ANOVA model with 2 degrees of freedom
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
F = 0.02, p = 0.89
114.81 ± 53.85
F = 7.46, p \ 0.01
125.84 ± 29.47
F = 5.29, p = 0.02
207.91 ± 36.61
F = 0.01, p = 0.91
72.90 ± 6.05
F = 0.19, p = 0.67
F = 1.25, p = 0.27
119.06 ± 12.65
F = 0.69, p = 0.41
5.06 ± 3.73
F = 2.67, p = 0.11
13.53 ± 6.59
F = 0.61, p = 0.44
3.04 ± 1.46
F = 0.62, p = 0.43
2.41 ± 1.94
F = 0.02, p = 0.90
5.55 ± 2.45
F = 1.40, p = 0.24
2.30 ± 0.60
119.97 ± 13.61
Independent variables in the model include education and age
a
2.19 ± 0.50 F = 0.77, p = 0.38
Model significanceb
121.60 ± 12.34
2.99 ± 3.33
8.81 ± 5.18
3.28 ± 2.04
2.17 ± 1.69
5.45 ± 3.15
2.53 ± 0.61
2.45 ± 0.52
Blood pressure (systolic)
Clinical measures
F = 0.11, p = 0.74
Model significanceb
F = 0.19, p = 0.67
2.75 ± 2.89
Model significance
8.45 ± 5.36
Moderate intensity
b
All physical activity
Physical activity measures (hours/week)
4.73 ± 2.60
Fruit and vegetables
NCI fruit and vegetable screener (servings/day)
2.42 ± 0.50
F = 0.39, p = 0.54
Dietary fat
Fat and Fiber Questionnaire (FAFQ summary scales)a
Dietary intake measures
EI (n = 47) mean ± SD
EI (n = 77) mean ± SD
MI (n = 78) mean ± SD
Post-intervention
Baseline
F = 4.78, p = 0.03
30.22 ± 5.57
F = 1.43, p = 0.24
120.07 ± 62.73
F = 2.95, p = 0.09
128.04 ± 28.67
F = 0.74, p = 0.39
210.96 ± 38.04
F = 2.74, p = 0.10
72.44 ± 9.41
F = 1.19, p = 0.28
119.52 ± 13.82
F = 0.10, p = 0.75
3.26 ± 3.17
F = 0.15, p = 0.70
8.48 ± 5.73
F = 3.73, p = 0.06
2.69 ± 0.99
F = 0.50, p = 0.48
2.15 ± 1.32
F = 0.72, p = 0.40
4.87 ± 1.78
F = 0.14, p = 0.71
2.25 ± 0.62
F = 1.17, p = 0.28
2.22 ± 0.40
EI (n = 30) mean ± SD
1-year
32.03 ± 8.06
101.23 ± 11.94
111.53 ± 28.41
198.26 ± 39.72
75.29 ± 9.55
119.61 ± 11.73
3.81 ± 3.87
10.00 ± 5.61
3.54 ± 2.01
2.08 ± 1.56
5.62 ± 3.03
2.43 ± 0.67
2.32 ± 0.43
MI (n = 37) mean ± SD
Table 2 Analysis of variance results for difference in mean dietary, physical activity and clinical measures between intervention groups at baseline, post-intervention, 1-year
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Model significance
F = 0.95, p = 0.33
b
a
F = 3.69, p = 0.06
30.22 ± 5.57
F = 0.04, p = 0.84
120.07 ± 62.73
F = 0.10, p = 0.75
128.04 ± 28.67
F = 0.05, p = 0.83
210.96 ± 38.04
F = 0.54, p = 0.47
72.44 ± 9.41
F = 0.49, p = 0.49
119.52 ± 13.82
F = 0.79, p = 0.38
3.26 ± 3.17
F \ 0.01, p = 0.99
8.48 ± 5.73
F = 0.13, p = 0.72
2.69 ± 0.99
F = 0.28, p = 0.60
2.15 ± 1.32
F = 0.04, p = 0.85
4.87 ± 1.78
F = 4.82, p = 0.03
2.25 ± 0.62
F = 2.98, p = 0.09
2.22 ± 0.40
32.03 ± 6.83
108.76 ± 33.20
118.15 ± 36.47
201.23 ± 43.00
75.38 ± 8.61
121.60 ± 12.34
2.99 ± 3.33
8.81 ± 5.18
3.28 ± 2.04
2.17 ± 1.69
5.45 ± 3.15
2.53 ± 0.61
2.45 ± 0.52
ANOVA model with 2 degrees of freedom. Models compare post-intervention and 1-year values with baseline values
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
Independent variables in the model include education and age
Model significanceb
F = 0.04, p = 0.85 31.80 ± 6.14
BMI (kg/m2)
32.86 ± 6.40
Model significanceb
F = 0.07, p = 0.80 114.81 ± 53.85
Blood glucose (mg/dL)
115.09 ± 51.76
Model significanceb
F = 0.01, p = 0.91 125.84 ± 29.47
LDL blood cholesterol
124.14 ± 35.29
Model significanceb
F = 0.24, p = 0.62 207.91 ± 36.61
Total blood cholesterol
206.65 ± 42.34
Model significanceb
72.90 ± 6.05
73.21 ± 8.05
Blood pressure (diastolic)
119.06 ± 12.65
F = 15.95, p \ 0.01
5.06 ± 3.73
F = 20.94, p \ 0.01
13.53 ± 6.59
F = 0.95, p = 0.33
119.97 ± 13.61
2.75 ± 2.89
8.45 ± 5.36
F = 0.78, p = 0.38
Model significanceb
Blood pressure (systolic)
Clinical measures
Model significanceb
Moderate intensity
b
All physical activity
Physical activity measures (hours/week)
Model significanceb
F = 2.13, p = 0.15 3.04 ± 1.46
Vegetables
2.80 ± 1.54
Model significanceb
2.41 ± 1.94
1.91 ± 1.76
Fruit
5.55 ± 2.45 F = 2.85, p = 0.09
4.73 ± 2.60
F = 7.00, p = 0.01
Model significanceb
Fruit and vegetables
NCI Fruit and Vegetable Screener (servings/day)
2.57 ± 0.53
2.30 ± 0.60
Model significanceb
Dietary fiber
2.19 ± 0.50 F = 6.65, p = 0.01
2.42 ± 0.50
Model significanceb
Dietary fat
Fat and Fiber Questionnaire (FAFQ summary scales)a
Dietary intake measures
BL (n = 78) mean ± SD
1YR (n = 30) mean ± SD
BL (n = 77) mean ± SD
PI (n = 47) mean ± SD
Minimum intervention
Enhanced intervention
Table 3 Analysis of variance results for mean change in dietary, physical activity and clinical outcomes within group over time
F = 0.20, p = 0.66
31.17 ± 6.99
F = 1.29, p = 0.26
102.96 ± 26.51
F = 2.59, p = 0.11
108.85 ± 29.79
F = 2.31, p = 0.13
190.91 ± 37.72
F = 5.28, p = 0.02
72.15 ± 6.13
F = 2.98, p = 0.09
117.83 ± 11.20
F = 3.59, p = 0.06
4.41 ± 4.92
F = 3.89, p = 0.05
11.11 ± 7.74
F = 1.90, p = 0.17
2.90 ± 1.39
F = 2.37, p = 0.13
2.81 ± 2.70
F = 0.08, p = 0.78
5.70 ± 3.24
F = 1.04, p = 0.31
2.40 ± 0.69
F = 3.672, p = 0.06
2.27 ± 0.44
PI (n = 53) mean ± SD
F = 0.47, p = 0.49
32.03 ± 8.06
F = 1.59, p = 0.21
101.23 ± 11.94
F = 0.86, p = 0.36
111.53 ± 28.41
F = 0.21, p = 0.65
198.26 ± 39.72
F = 0.05, p = 0.82
75.29 ± 9.55
F = 0.30, p = 0.58
119.61 ± 11.73
F = 0.57, p = 0.45
3.81 ± 3.87
F = 0.72, p = 0.40
10.00 ± 5.61
F = 0.15, p = 0.70
3.54 ± 2.01
F = 0.63, p = 0.43
2.08 ± 1.56
F = 0.03, p = 0.87
5.62 ± 3.03
F = 0.37, p = 0.55
2.43 ± 0.67
F = 0.76, p = 0.38
2.32 ± 0.43
1YR (n = 37) mean ± SD
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J Community Health Table 4 Intent-to-treat analysis for dietary, physical activity and clinincal outcomes Post intervention EI Effect size (CI)
1 year MI Effect size (CI)
EI Effect size (CI)
MI Effect size (CI)
-0.11 (-0.40, 0.18) -0.15 (-0.44, 0.14)
-0.27 (-0.56, 0.02) -0.46 (-0.76, -0.17)
-0.20 (-0.49, 0.09) -0.09 (-0.38, 0.20)
-0.01 (-0.30, 0.28)
0.12 (-0.17, 0.42)
-0.14 (-0.43, 0.16)
Dietary intake measures Fat and Fiber Questionnaire (FAFQ summary scales)a Dietary fat Dietary fiber
-0.43 (-0.73, -0.14) -0.52 (-0.82, -0.22)
NCI fruit and vegetable screener (servings/day) Fruit and vegetables
0.21 (-0.09, 0.50)
Physical activity measures (hours/week) All physical activity
0.64 (0.34, 0.94)
0.44 (0.14, 0.73)
0.27 (-0.03, 0.56)
0.28 (-0.02, 0.57)
Moderate intensity
0.71 (0.40, 1.01)
0.32 (0.02, 0.61)
0.30 (0.01, 0.60)
0.17 (-0.12, 0.46)
Clinical measures Systolic blood pressure (mmHg)
-0.21 (-0.50, 0.08)
-0.35 (-0.65, -0.06)
-0.47 (-0.76, -0.17)
-0.03 (-0.32, 0.26)
Diastolic blood pressure (mmHg)
-0.14 (-0.43, 0.15)
-0.48 (-0.77, -0.18)
-0.21 (-0.51, 0.08)
0.11 (-0.19, 0.4)
Total blood cholesterol (mg/dL)
-0.14 (-0.43, 0.15)
-0.20 (-0.49, 0.10)
-0.07 (-0.36, 0.22)
-0.13 (-0.42, 0.17)
LDL blood cholesterol (mg/dL)
-0.15 (-0.44, 0.15)
-0.20 (-0.49, 0.10)
-0.02 (-0.31, 0.27)
-0.25 (-0.55, 0.04)
Blood glucose (mg/dL)
-0.15 (-0.44, 0.15)
-0.16 (-0.45, 0.13)
-0.29 (-0.59, 0.00)
-0.36 (-0.65, -0.06)
BMI (kg/m2)
-0.27 (-0.56, 0.02)
-0.18 (-0.48, 0.11)
-0.34 (-0.63, -0.05)
-0.05 (-0.35, 0.24)
Effect sizes reported as Cohen’s d statistic a
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
demonstrates how baseline dietary intake could be used to modify the intervention. For example, if participants are meeting recommendations for fruit and vegetable intake, more time could be spent on lowering dietary fat intake. EI participants had greater success at improving their levels of physical activity than MI participants. Similar results have been reported by WISEWOMAN programs in California and Arizona [27–29]. Changes for both moderate and total physical activity among the EI group were statistically significant at post-intervention, and moderate effect sizes showed that there was a meaningful increase in the actual number of minutes of both types of activity. This indicates that participants in the EI were successful in achieving greater levels of physical activity because of the knowledge, skills and support they received through the IWP intervention. These changes were larger for the Spanish speaking sample than for the English speaking sample [11]. However, by 1 year, activity levels were similar to baseline, suggesting the need to find better long term solutions to help this population overcome barriers to physical activity. IWP may draw on lessons from the Arizona and California WISEWOMAN programs, which had greater success after 1 year. Those programs included follow-up informational sessions beyond the time of the initial intervention, and incorporated multiple levels of education and support. Participants in the EI group showed a significant reduction in BMI levels which are parallel to the increase
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in physical activity levels. This reduction in BMI moved women from the obese category to the range defined as overweight. This degree of change in BMI levels was not seen in the English speaking sample as has been reported before [11]. The timeline of changes in the EI group is consistent with the fact that behavioral changes can be measured in the short-term, but changes in clinical measures take longer to manifest. So while diet and physical activity measures showed improvements at post-intervention, the change in BMI was not seen until the 1-year follow-up. Marginal improvement was seen in diastolic and systolic blood pressure, for the MI group at post-intervention, but it was not sustained at 1 year. This may demonstrate that participants were initially motivated to make lifestyle changes because of participation in the baseline screenings and the educational materials provided. However, it appears these steps were not adequate for producing long term change, reinforcing the need to incorporate more measures to sustain behavior changes, such as those used in Arizona and California. This program targets underinsured and uninsured women enrolled in the IBCCP, a population that is at risk for CVD. As with most community-based studies, we were not able to randomly select women from the general population to meet our inclusion criteria, so our sample is not generalizable to the general population but may reasonably be generalized to women with characteristics similar to
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study participants. Strengths of the study include its use of intermediate behavioral outcomes and long-term clinical outcomes and the success of randomization, as participants in the two groups showed no differences in demographic characteristics or clinical measures at baseline. Recruitment and retention of participants was a challenge in this study. Participants in the EI group had higher rates of attrition than the MI group at post-intervention, although the rates were similar at the 1-year follow-up. However, since participants were randomly assigned to intervention groups, it is more likely that attrition is a result of the length of the intervention rather than participant characteristics. Overall, there were no differences between the completers and non-completers in the MI group. EI participants who completed the intervention had a lower income, higher levels of cholesterol and lower physical activity levels than the non-completers. These findings suggest that low-income women with a high-risk for CVD maybe more motivated to improve behaviors and hence targeting them may improve retention. The pilot test clearly showed that support from family was critical to participation in this population. Future implementations should consider ways to further involve the family in the intervention. System issues that affect attendance such as transportation and childcare should also be considered.
Conclusion The IWP Spanish-language arm was moderately successful in addressing risk factors for CVD in this population. The longest lasting impacts of the program appear to have been an increase in fiber intake and a decrease in BMI. Findings suggest that adaptations made to the IWP based on the results of the pilot test contributed to the positive changes that have been demonstrated in the intervention group. Future implementations may benefit from further tailoring of the program to this population, and learning from the successes of Spanish-language WISEWOMAN programs in other states. Acknowledgments We are very grateful for the leadership of Sharon Green and Pamela W. Balmer from the Illinois Department of Public Health. We thank Katie Zinn for her extensive work developing the protocol, and LaRhonda Williams for early leadership of this program. We respect the hard work and commitment of the staff at DuPage, Fulton, and Stephenson County Health Departments, Mercy Hospital, and St. Mary’s Hospital for implementing this program. We appreciate the assistance of Ruth Ann Carpenter, Heather Chambliss and Rachel Huber in the development of the original curriculum materials, and Susan Auger for her helpful guidance with tailoring the curriculum to better serve the needs of the target population. We thank Melida Colindres and Rosario Montoya for translating and back-translating the curriculum and facilitator
materials. Finally, we greatly appreciate the study participants for their time and dedication to the Illinois WISEWOMAN Program. This research was funded by CDC Cooperative Agreement Number U58/CCU522815. Conflict of interest
None.
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23. Stewart, A. L., Mills, K. M., King, A. C., Haskell, W. L., Gillis, D., & Ritter, P. L. (2001). CHAMPS physical activity questionnaire for older adults: Outcomes for interventions. Medicine and Science in Sports and Exercise, 33, 1126–1141. 24. Marin, G., Sabogal, F., Marin, B. V., Otero-Sabogal, R., & PerezStable, E. J. (1987). Development of a short acculturation scale for Hispanics. Hispanic Journal of Behavioral Sciences, 9(2), 183–205. 25. Cohen, J. (1988). Statistical power and analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates. 26. IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp. 27. Hayashi, T., Farrell, M. A., Chaput, L. A., Rocha, D. A., & Hernandez, M. (2010). Lifestyle intervention, behavioral changes, and improvement in cardiovascular risk profiles in the California WISEWOMAN Project. Journal of Womens Health, 19(6), 1129–1138. 28. Staten, L. K., Gregory-Mercado, K. Y., Ranger-Moore, J., et al. (2004). Provider counseling, health education, and community health workers: The Arizona WISEWOMAN project. Journal of Womens Health, 13(5), 547–556. 29. Coleman, K. J., Farrell, M. A., Rocha, D. A., et al. (2012). Readiness to be physically active and self-reported physical activity in low-income Latinas, California WISEWOMAN, 2006–2007. Preventing Chronic Disease, 9, 110190. doi:10.5888/ pcd9.110190.
ORIGINAL PAPER
Lifestyle Intervention and Cardiovascular Disease Risk Reduction in Low-Income Hispanic Immigrant Women Participating in the Illinois WISEWOMAN Program Manorama M. Khare • John F. Cursio • Cara A. Locklin • Nancy J. Bates • Ryan K. Loo
Ó Springer Science+Business Media New York 2014
Abstract Cardiovascular disease (CVD) is the leading cause of death for Hispanic women in the United States. In 2001, the Illinois Department of Public Health received funding from the Centers for Disease Control and Prevention to implement the enhanced WISEWOMAN program (IWP) to address the disproportionate CVD risk among uninsured and underinsured women enrolled in the Illinois Breast and Cervical Cancer Early Detection Program. This paper presents the results of the Spanish-language arm of the IWP. Spanish speaking IWP participants were recruited from two sites, and randomized into either the minimum intervention (MI) or the enhanced intervention (EI) group. Both groups received CVD risk factor screening and educational handouts. The EI group also received an integrated 12-week nutrition and physical activity lifestyle change
M. M. Khare (&) Division of Health Policy and Social Science Research, Department of Family and Community Medicine, University of Illinois College of Medicine at Rockford, 1601 Parkview Avenue, Rockford, IL 61107-1897, USA e-mail: [email protected] J. F. Cursio Center for Quality, University of Chicago Hospital, Chicago, IL, USA C. A. Locklin Center for Research on Women and Gender, University of Illinois at Chicago, Chicago, IL, USA N. J. Bates Center for Clinical and Translational Science, University of Illinois at Chicago, Chicago, IL, USA R. K. Loo Spectrum Health Policy Research, LLC, Lawrenceville, GA, USA
intervention. Of the 180 Spanish-speaking immigrants in this sample, 90 (50 %) received the EI and 90 (50 %) received the MI. At baseline there were no significant differences between group demographics or clinical values. At post-intervention, the EI group showed improvements in fat intake, fiber intake, moderate intensity physical activity, and total physical activity. At 1 year only the change in fiber intake remained. A significant improvement was also seen in body mass index (BMI) at the 1-year follow-up. The IWP Spanish-language arm was moderately successful in addressing risk factors for CVD in this population. The behavior changes that sustained up to a year were an increase in fiber intake and a decrease in BMI. Keywords Cardiovascular health Physical activity Nutrition Hispanic
Introduction Cardiovascular disease (CVD) is the leading cause of death for Hispanic women in the United States, resulting in 29.6 % of deaths in 2009 [1, 2]. Numerous modifiable risk factors such as high dietary intake of fat and sodium, low dietary intake of fruits and vegetables, lack of physical activity, stress, alcohol consumption, and smoking are associated with an increased risk for CVD [3, 4]. Women of minority ethnic groups and low socioeconomic status (SES) are more likely to report these risk factors than white women and women of higher SES [5, 6]. Among Hispanic women, lower rates of physical activity may be influenced by traditional gender roles that encourage women to place domestic duties as first priority, leaving little personal time for physical activity [6, 7]. Hispanic immigrant women also report eating fewer fresh
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fruits and vegetables, and consuming more high-calorie meals at fast food restaurants in the United States than in their native countries [7, 8]. Because of these cultural factors, tailored interventions have been shown to be more effective at addressing CVD risk in Hispanic immigrant women [9, 10]. In 2001, the Illinois Department of Public Health (IDPH) received funding from the Centers for Disease Control and Prevention (CDC) to implement the enhanced WISEWOMAN program (IWP). This program was designed to address the disproportionate CVD risk among women enrolled in the Illinois Breast and Cervical Cancer Early Detection Program (IBCCP). The IWP intervention was implemented with a total of 1,021 women, 833 who participated in the English-language arm and 188 who participated in the Spanish-language arm. Of the Spanish speakers, 180 reported being first generation immigrants. Results of the English language implementation have shown that IWP was effective in improving dietary and physical activity outcomes in the enhanced intervention (EI) group both at post-intervention and the 1-year followup. In this paper we report the results of the IWP for Spanish-speaking immigrant women and present the changes in dietary, physical activity and clinical indicators from baseline to post-intervention and 1-year follow-up. Our hypothesis was that participants in the EI group will have improved behavioral and clinical outcomes as compared to the participants in the minimum intervention (MI) group at post-intervention and the 1-year follow-up.
Methods The Illinois IWP was developed collaboratively among IDPH, the University of Illinois at Chicago’s (UIC) National Center for Excellence in Women’s Health, The Cooper Institute (CI), and CDC. The IWP study used a randomized two-group design to assess the effectiveness of the 12-week lifestyle change intervention in reducing CVD risk in underinsured or uninsured woman aged 40–64 years enrolled in the IBCCP program. The Western Institutional Review Board approved the project, and informed consent was obtained from all participants prior to enrollment in the IWP. The UIC Institutional Review Board approved the overall evaluation of this project. IWP recruited IBCCP participants for the Spanish-language arm from two sites. Women who chose to participate were randomized into either the MI or the EI group. Participants were informed of their assignments via phone. Participants in both the MI and EI group received CVD risk factor screening; CVD-related educational handouts from the American Heart Association and the National Institutes of Health; referrals for physician care as needed; follow-up
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assessments at one and 2 years from baseline; and postcards and newsletters. In addition, the EI group received a 12-week lifestyle change intervention. Demographic information, a health history assessment that identified women who needed medical clearance to participate in the program, behavioral assessments, an acculturation scale and clinical measures were collected at baseline. Behavioral assessments and clinical measures were also collected at post-intervention, and one and 2 years from baseline. The IWP design, curriculum and methods are described in greater detail elsewhere [11–14]. IWP Curriculum The IWP curriculum was designed by CI in collaboration with IDPH and UIC by adapting its evidence-based nutrition and physical activity curricula to the target population [15, 16]. These curricula are based on the constructs of the Social Cognitive Theory (SCT) [17] and the Transtheoretical Model [18]. Further details about the IWP curriculum have been reported elsewhere [13]. Pilot testing of both the English and Spanish language IWP curriculum showed that the materials were at too high a reading level for the participants and there was excessive content in each session. The IWP team worked with a literacy expert to modify the reading level of the materials to a 4th grade level, and the teaching was shifted from a pedagogical, didactic classroom approach to more of an interactive, andragogical approach [19] that emphasized group discussions, games, and team competitions. Details about the curriculum have been published earlier [13]. To develop a Spanish version of the IWP curriculum a rigorous process of translation and back-translation was used. The first translator did a universal translation, for all of Latin America with a focus on Mexico and Central America, since our target population was primarily from these regions. Another translator back-translated the Spanish curriculum to English. To ensure equivalency and consistency between the two curricula the curriculum developers reviewed the version back-translated to English for incorrect or discrepant materials and worked with the back translator to correct these discrepancies. At the time it was implemented, the IWP was the only WISEWOMAN program in the country to offer a Spanish curriculum. The Spanish-language IWP intervention was pilot tested with a total of 29 participants who were randomized into the EI and MI groups. The primary objective was to test the curriculum and education materials for appropriateness in the target population and to evaluate both process and outcome measures. The process evaluation identified issues related to recruitment methods, transportation, and lack of family support as barriers to the success of the intervention. These issues were addressed in the full-implementation of
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the Spanish-language IWP. An orientation session that included family members was added to the Spanish-language program, as support from families was found to be a critical factor in continued participation for this population. This addition of an orientation session was unique to the Spanish implementation of the program. Behavioral Measures Self-reported responses to validated nutrition and physical activity scales were used to assess the health behaviors of participants. The Fat and Fiber Questionnaire (FAFQ) [20] and the National Cancer Institute All Day Fruit and Vegetable Screener (FVS) [21] were the nutrition measures used. The FAFQ produces summary scores for fat and fiber intake and assesses eating behaviors related to choosing and preparing low-fat and high-fiber diets. The instrument uses a four point scale, where lower total scores indicate healthier eating habits. The FAFQ is a modified version of the Eating Patterns Questionnaire reported in Shannon et al. [21]. Modification included adding Latino foods and food preparation methods, accommodating language differences among Latinos from Mexico, Puerto Rico and Central America and translation/back translation into Spanish [22]. The FVS determines average number of fruit and vegetable servings consumed per day. Physical activity was assessed using a questionnaire from the Community Healthy Activities Model Program for Seniors (CHAMPS) [23]. The two summary scores from the CHAMPS survey used in this analysis were hours per week engaged in ‘‘all physical activity’’ and hours per week engaged in ‘‘moderate intensity activity’’. Clinical Measures Height and weight were collected to compute body mass index (BMI). Additional clinical measures included blood pressure, lipid counts (total cholesterol and LDL cholesterol), and blood glucose levels. Data Analysis Data were collected at individual sites and entered into the State of Illinois data system by the coordinators at each site. Data were electronically transferred to a secure server at University of Illinois at Chicago. Demographic characteristics of the EI and MI groups were compared at baseline using independent t-tests for age and Chi square statistics for race, education, and acculturation. Acculturation was measured using questions from the Marin Short Acculturation Scale [24]. Analysis of variance (ANOVA) was used to compare mean scale scores between the EI and MI groups for the FAFQ, FVS, and CHAMPS at each time
point. Chi squared analysis was used to compare attrition rates between groups. Completer to non-completer comparisons were conducted within each treatment group to determine if any characteristics were associated with attrition. Participants who attended the post-intervention appointment and completed the assessments were labeled as study completers, and those who did not complete the assessments were labeled as non-completers. The primary outcome measures in this analysis include: the FAFQ fat summary scale score; the FAFQ fiber summary scale score; the FVS score (total intake of fruit and vegetable servings per day); the CHAMPS all intensity physical activity; the CHAMPS moderate intensity physical activity; and clinical measures of total cholesterol, total glucose, LDL cholesterol and BMI. Changes over time within each intervention group were assessed using ANOVA. ANOVAs were conducted separately for each outcome measure using age, education, and intervention group (EI or MI) as independent variables. Effect sizes were calculated using Cohen’s d-statistic [25], which describes the magnitude of the difference between the mean score for each group at specific time points. Intent-totreat (ITT) analysis was conducted to present the hypothetical effect size for all participants assigned to the intervention, including those who dropped out. Statistical analysis was conducted using IBM SPSS Statistics v. 21 [26].
Results Sample Description Demographic characteristics of the sample are presented in Table 1. The 180 Spanish-speaking immigrants in this sample made up 17.6 % of the IBCCP participants recruited into the IWP; 90 (50 %) received the EI and 90 (50 %) received the MI. At baseline there were no significant differences between the EI and MI groups by age (p = 0.48), education (p = 0.49), or acculturation level (p = 0.97). The mean age of participants was 50.9 ± 6.9 years. Nearly twothirds of the participants (65.8 %) had no more than an eighth-grade education. Using questions from the Marin Short Acculturation Scale [24], participants had a mean acculturation score of 1.3 ± 0.6, indicating that the participants preferred Spanish over English for daily communication. The average amount of time spent living in the United States was 16.5 ± 10.9 years with a range of 1–55 years. Medical Referrals All participants completed a baseline health history and a clinical assessment prior to being randomized. Participants with abnormal levels of total blood cholesterol ([200 mg/dL),
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J Community Health Table 1 Demographic characteristics of participants at baseline by intervention group EI (n = 90)
MI (n = 90)
Total (n = 180)
p value
Mean age (mean ± SD)
51.23 ± 6.73
50.51 ± 7.04
50.87 ± 6.88
0.48
Age range (min, max)
40.39–64.64
40.06–64.61
40.06–64.64
Education, n (%)
0.49
B8th grade
54 (70.1)
48 (61.5)
9th–12th grade
18 (23.4)
22 (28.2)
40 (25.8)
C13 years
5 (6.5)
8 (10.3)
13 (8.4)
1.27 ± 0.61
1.27 ± 0.57
1.27 ± 0.59
58 (64.4)
59 (65.6)
117 (65.0)
Acculturation (mean ± SD)
102 (65.8)
Language acculturationa, n (%) Least acculturated (=1) Somewhat acculturated ([1 and B2) Most acculturated ([2) Years in US (mean ± SD)
0.97 0.29
30 (33.3)
25 (27.8)
55 (30.6)
2 (2.2) 16.93 ± 11.26
6 (6.7) 16.01 ± 10.52
8 (4.4) 16.47 ± 10.88
0.58
Independent t-tests were used for continuous variables and Chi square tests were used for categorical variables. No significant differences in baseline measures were seen between the EI and MI groups a
Scale of 1–5, where 1 is the least and 5 is the most acculturated
blood pressure ([140 mmHg systolic or [90 mmHg diastolic), or blood glucose ([125 mg/dL) were provided medical referrals but did not need written clearance from a physician to participate in the program. Participants with alert levels for any of these measures (total cholesterol [400 mg/ dL, systolic blood pressure [180 mmHg, diastolic blood pressure [110 mmHg, or blood glucose [375 mg/dL) were provided medical referrals and needed written permission from a physician to participate in the program. A total of 112 participants (62.2 %) had abnormal clinical values. Only one participant had an alert clinical value. Participants were also asked about their health history using a questionnaire. Written medical clearance was required if they indicated having problems involving the heart or joints, any other acute medical problems, or if a doctor had placed restrictions on their level of physical activity. Forty-eight participants (26.7 %) required written medical clearance based on positive responses to health history questions. All participants with alert values or positive health history obtained medical clearance and were randomized into the study. There were no significant differences between the EI and MI group for participants with alert values, or participants requiring medical clearance because of positive responses on the health history questionnaire. However, participants in the EI group (71.1 %) were significantly more likely to have abnormal clinical values that required a medical referral at baseline as compared to participants in the MI group (53.3 %) (v2 = 6.05, p = 0.01).
(30.0 %) attended between seven and eleven sessions, and another 27 (30.0 %) attended all twelve sessions. Attrition At post-intervention, 40 % of the EI participants had left the study as compared to 26.7 % of the MI participants (v2 = 3.6, p = 0.06). At baseline, there were no differences between completers and non-completers in age, education, acculturation, or number of years in the United States. When stratified by intervention group, there were no statistically significant differences between completers and non-completers in the MI group. However, completers within the EI group, had a lower education level (v2 = 7.79, p = 0.02), higher baseline total cholesterol levels (t = -2.00, p = 0.05), and fewer minutes of moderate physical activity levels at baseline (t = 2.02, p = 0.05). After 1 year, there was no significant difference in attrition rate for the EI (66.7 %) and MI (58.9 %) groups. Overall, those who completed the 1-year appointment had fewer minutes of total physical activity at baseline than non-completers (t = 3.58, p \ 0.01). In the EI group, those who completed the 1-year appointment had less total physical activity (p \ 0.01), higher systolic blood pressure (t = 2.96, p \ 0.01), and lower BMI (t = 2.09, p = 0.04) at baseline than the non-completers. In the MI group, those who completed the 1-year appointment were younger (t = 2.22, p = 0.03) and had a higher education level (v2 = 8.38, p = 0.02) than those who did not.
Session Attendance Primary Outcomes Attendance records for participants in the EI group show that 25 participants (27.8 %) did not attend any sessions, eleven (12.2 %) attended between one and six sessions, 27
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At baseline, there were no statistically significant differences between the EI and MI groups for any of the primary
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outcome measures (Table 2). Improvements in health behaviors were seen at post-intervention but not sustained at 1 year. Between-group comparisons at each time point for the fat and fiber summary scale scores showed no statistically significant differences at baseline, post-intervention, or the 1-year follow-up (Table 2). As seen in Table 3, participants within the EI group had statistically significant improvements in the dietary fat and dietary fiber summary scores from baseline to post-intervention (p = 0.01 and p = 0.01). At 1 year, the change in fiber score remained significant (p = 0.03), and the change in the fat score was marginally significant (p = 0.09). The MI group did not show improvement in either score at post-intervention or 1 year. Comparing the EI and MI groups at each time-point we found no statistically significant differences in the number of servings of fruits and vegetables consumed (Table 2). Intake of fruits and vegetables also did not differ within groups over time (Table 3). As seen in Table 2, there was no statistically significant difference in levels of total physical activity and moderate intensity physical activity between the EI and MI groups at any time-point. Participants in the EI group showed a statistically significant increase in both total physical activity (p \ 0.01) and moderate intensity physical activity (p \ 0.01) from baseline to post-intervention. However, at 1 year, levels were similar to baseline (Table 3). There was no change in physical activity levels for the MI group. Table 2 shows that at post-intervention, total blood cholesterol and LDL cholesterol were significantly lower for the MI group than the EI group (p = 0.02, p \ 0.01). However these differences did not sustain at the 1-year follow-up. As presented in Table 3, none of the clinical measures changed significantly within the EI group over time. Diastolic blood pressure improved significantly for the MI group at post-intervention, but that change was not maintained at 1 year. At the 1-year follow-up, however, BMI for the EI group was 1.81 units lower than that of the MI group (p = 0.03) and decreased gradually in the EI from baseline to 1-year for a loss of 2.64 units (p = 0.06). Effect Size Analysis Table 4 presents the results of the effect size analysis for the fat and fiber scores, servings of fruit and vegetables, physical activity measures, and clinical measures by treatment group at post-intervention and 1-year follow-up visits. The effect size reflects the standardized differences between the treatment group means at baseline and the follow-up visit and is based on Cohen’s d-statistic formula [25]. All analyses were done using the ITT principle. At the post-intervention visit, the largest effect sizes were seen for
levels of all physical activity (d = 0.64) and moderate intensity activity (d = 0.71) in the EI group. These effect sizes were larger than those seen in the MI group. Effect sizes for the fat (d = -0.43) and fiber (d = -0.52) summary scale scores were also moderate to strong in the EI group. Moderate effect sizes were seen in systolic blood pressure (d = -0.35) and diastolic blood pressure (d = -0.48) for the MI group at post-intervention. At the 1-year follow-up, moderate effect sizes were seen in dietary fiber (d = -0.46), moderate intensity activity (d = 0.30), systolic blood pressure (d = -0.47), and BMI (d = -0.34) in the EI group. A moderate effect size in blood glucose (d = -0.36) was seen in the MI group. Negative effect sizes for the fat and fiber summary scale scores indicate an improvement in fat and fiber related behaviors.
Discussion The IWP proved to be moderately effective at improving some risk factors for CVD in Spanish speaking immigrant women. Participants in the EI group showed positive changes in diet and physical activity outcomes at postintervention. At 1 year they maintained an increase in dietary fiber intake and had improved BMI levels. Participants in the EI group significantly improved their fat and fiber summary scale scores at post-intervention and maintained the increased fiber intake at 1 year. Effect size analysis showed that the actual size of the change in fiber scores was large, although decreasing slightly at 1 year (Table 4), and the change in dietary fat summary score at post-intervention was moderate. Fat and fiber changes in the Spanish speaking population were smaller than in the English speaking sample [11]. IWP participants were more successful in increasing fiber consumption than in reducing fat consumption. This suggests that it was easier for participants to include new, healthy foods into their diet than to restrict foods they are accustomed to eating. For example, tips to increase fiber intake included adding more beans and whole grains to recipes, substituting part of the flour in a baking recipe with whole wheat flour, choosing whole grain breads by reading labels. Tips to reduce fat intake included substituting leaner cuts of meat in recipes, substituting butter with oil, and using lower fat salad dressings which may be harder practices to change. In addition, intake of fruits and vegetables did not change significantly in the EI group. However, participants in both groups were already eating approximately the recommended five servings of fruits and vegetables per day at baseline, and they maintained similar intake throughout the study. They may have realized that their intake was adequate, and therefore did not attempt to increase it. This also
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2.57 ± 0.53
F = 0.33, p = 0.57
Model significanceb
Dietary fiber
Model significanceb
F = 1.75, p = 0.19
1.91 ± 1.76
F = 0.58, p = 0.45
2.80 ± 1.54
F = 2.06, p = 0.15
Model significanceb
Fruit
Model significanceb
Vegetables
Model significanceb
F = 1.66, p = 0.20 31.80 ± 6.14
F = 3.66, p = 0.06
206.65 ± 42.34
F = 0.65, p = 0.42
124.14 ± 35.29
F = 1.06, p = 0.31
115.09 ± 51.76
F = 0.72, p = 0.40
32.86 ± 6.40
F = 0.33, p = 0.57
Model significanceb
Total blood cholesterol
Model significanceb
LDL blood cholesterol
Model significanceb
Blood glucose (mg/dL)
Model significanceb
BMI (kg/m2)
Model significanceb
32.03 ± 6.83
108.76 ± 33.20
118.15 ± 36.47
201.23 ± 43.00
75.38 ± 8.61
73.21 ± 8.05
Blood pressure (diastolic)
b
31.17 ± 6.99
102.96 ± 26.51
108.85 ± 29.79
190.91 ± 37.72
72.15 ± 6.13
117.83 ± 11.20
4.41 ± 4.92
11.11 ± 7.74
2.90 ± 1.39
2.81 ± 2.70
5.70 ± 3.24
2.40 ± 0.69
2.27 ± 0.44
MI (n = 53) mean ± SD
ANOVA model with 2 degrees of freedom
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
F = 0.02, p = 0.89
114.81 ± 53.85
F = 7.46, p \ 0.01
125.84 ± 29.47
F = 5.29, p = 0.02
207.91 ± 36.61
F = 0.01, p = 0.91
72.90 ± 6.05
F = 0.19, p = 0.67
F = 1.25, p = 0.27
119.06 ± 12.65
F = 0.69, p = 0.41
5.06 ± 3.73
F = 2.67, p = 0.11
13.53 ± 6.59
F = 0.61, p = 0.44
3.04 ± 1.46
F = 0.62, p = 0.43
2.41 ± 1.94
F = 0.02, p = 0.90
5.55 ± 2.45
F = 1.40, p = 0.24
2.30 ± 0.60
119.97 ± 13.61
Independent variables in the model include education and age
a
2.19 ± 0.50 F = 0.77, p = 0.38
Model significanceb
121.60 ± 12.34
2.99 ± 3.33
8.81 ± 5.18
3.28 ± 2.04
2.17 ± 1.69
5.45 ± 3.15
2.53 ± 0.61
2.45 ± 0.52
Blood pressure (systolic)
Clinical measures
F = 0.11, p = 0.74
Model significanceb
F = 0.19, p = 0.67
2.75 ± 2.89
Model significance
8.45 ± 5.36
Moderate intensity
b
All physical activity
Physical activity measures (hours/week)
4.73 ± 2.60
Fruit and vegetables
NCI fruit and vegetable screener (servings/day)
2.42 ± 0.50
F = 0.39, p = 0.54
Dietary fat
Fat and Fiber Questionnaire (FAFQ summary scales)a
Dietary intake measures
EI (n = 47) mean ± SD
EI (n = 77) mean ± SD
MI (n = 78) mean ± SD
Post-intervention
Baseline
F = 4.78, p = 0.03
30.22 ± 5.57
F = 1.43, p = 0.24
120.07 ± 62.73
F = 2.95, p = 0.09
128.04 ± 28.67
F = 0.74, p = 0.39
210.96 ± 38.04
F = 2.74, p = 0.10
72.44 ± 9.41
F = 1.19, p = 0.28
119.52 ± 13.82
F = 0.10, p = 0.75
3.26 ± 3.17
F = 0.15, p = 0.70
8.48 ± 5.73
F = 3.73, p = 0.06
2.69 ± 0.99
F = 0.50, p = 0.48
2.15 ± 1.32
F = 0.72, p = 0.40
4.87 ± 1.78
F = 0.14, p = 0.71
2.25 ± 0.62
F = 1.17, p = 0.28
2.22 ± 0.40
EI (n = 30) mean ± SD
1-year
32.03 ± 8.06
101.23 ± 11.94
111.53 ± 28.41
198.26 ± 39.72
75.29 ± 9.55
119.61 ± 11.73
3.81 ± 3.87
10.00 ± 5.61
3.54 ± 2.01
2.08 ± 1.56
5.62 ± 3.03
2.43 ± 0.67
2.32 ± 0.43
MI (n = 37) mean ± SD
Table 2 Analysis of variance results for difference in mean dietary, physical activity and clinical measures between intervention groups at baseline, post-intervention, 1-year
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Model significance
F = 0.95, p = 0.33
b
a
F = 3.69, p = 0.06
30.22 ± 5.57
F = 0.04, p = 0.84
120.07 ± 62.73
F = 0.10, p = 0.75
128.04 ± 28.67
F = 0.05, p = 0.83
210.96 ± 38.04
F = 0.54, p = 0.47
72.44 ± 9.41
F = 0.49, p = 0.49
119.52 ± 13.82
F = 0.79, p = 0.38
3.26 ± 3.17
F \ 0.01, p = 0.99
8.48 ± 5.73
F = 0.13, p = 0.72
2.69 ± 0.99
F = 0.28, p = 0.60
2.15 ± 1.32
F = 0.04, p = 0.85
4.87 ± 1.78
F = 4.82, p = 0.03
2.25 ± 0.62
F = 2.98, p = 0.09
2.22 ± 0.40
32.03 ± 6.83
108.76 ± 33.20
118.15 ± 36.47
201.23 ± 43.00
75.38 ± 8.61
121.60 ± 12.34
2.99 ± 3.33
8.81 ± 5.18
3.28 ± 2.04
2.17 ± 1.69
5.45 ± 3.15
2.53 ± 0.61
2.45 ± 0.52
ANOVA model with 2 degrees of freedom. Models compare post-intervention and 1-year values with baseline values
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
Independent variables in the model include education and age
Model significanceb
F = 0.04, p = 0.85 31.80 ± 6.14
BMI (kg/m2)
32.86 ± 6.40
Model significanceb
F = 0.07, p = 0.80 114.81 ± 53.85
Blood glucose (mg/dL)
115.09 ± 51.76
Model significanceb
F = 0.01, p = 0.91 125.84 ± 29.47
LDL blood cholesterol
124.14 ± 35.29
Model significanceb
F = 0.24, p = 0.62 207.91 ± 36.61
Total blood cholesterol
206.65 ± 42.34
Model significanceb
72.90 ± 6.05
73.21 ± 8.05
Blood pressure (diastolic)
119.06 ± 12.65
F = 15.95, p \ 0.01
5.06 ± 3.73
F = 20.94, p \ 0.01
13.53 ± 6.59
F = 0.95, p = 0.33
119.97 ± 13.61
2.75 ± 2.89
8.45 ± 5.36
F = 0.78, p = 0.38
Model significanceb
Blood pressure (systolic)
Clinical measures
Model significanceb
Moderate intensity
b
All physical activity
Physical activity measures (hours/week)
Model significanceb
F = 2.13, p = 0.15 3.04 ± 1.46
Vegetables
2.80 ± 1.54
Model significanceb
2.41 ± 1.94
1.91 ± 1.76
Fruit
5.55 ± 2.45 F = 2.85, p = 0.09
4.73 ± 2.60
F = 7.00, p = 0.01
Model significanceb
Fruit and vegetables
NCI Fruit and Vegetable Screener (servings/day)
2.57 ± 0.53
2.30 ± 0.60
Model significanceb
Dietary fiber
2.19 ± 0.50 F = 6.65, p = 0.01
2.42 ± 0.50
Model significanceb
Dietary fat
Fat and Fiber Questionnaire (FAFQ summary scales)a
Dietary intake measures
BL (n = 78) mean ± SD
1YR (n = 30) mean ± SD
BL (n = 77) mean ± SD
PI (n = 47) mean ± SD
Minimum intervention
Enhanced intervention
Table 3 Analysis of variance results for mean change in dietary, physical activity and clinical outcomes within group over time
F = 0.20, p = 0.66
31.17 ± 6.99
F = 1.29, p = 0.26
102.96 ± 26.51
F = 2.59, p = 0.11
108.85 ± 29.79
F = 2.31, p = 0.13
190.91 ± 37.72
F = 5.28, p = 0.02
72.15 ± 6.13
F = 2.98, p = 0.09
117.83 ± 11.20
F = 3.59, p = 0.06
4.41 ± 4.92
F = 3.89, p = 0.05
11.11 ± 7.74
F = 1.90, p = 0.17
2.90 ± 1.39
F = 2.37, p = 0.13
2.81 ± 2.70
F = 0.08, p = 0.78
5.70 ± 3.24
F = 1.04, p = 0.31
2.40 ± 0.69
F = 3.672, p = 0.06
2.27 ± 0.44
PI (n = 53) mean ± SD
F = 0.47, p = 0.49
32.03 ± 8.06
F = 1.59, p = 0.21
101.23 ± 11.94
F = 0.86, p = 0.36
111.53 ± 28.41
F = 0.21, p = 0.65
198.26 ± 39.72
F = 0.05, p = 0.82
75.29 ± 9.55
F = 0.30, p = 0.58
119.61 ± 11.73
F = 0.57, p = 0.45
3.81 ± 3.87
F = 0.72, p = 0.40
10.00 ± 5.61
F = 0.15, p = 0.70
3.54 ± 2.01
F = 0.63, p = 0.43
2.08 ± 1.56
F = 0.03, p = 0.87
5.62 ± 3.03
F = 0.37, p = 0.55
2.43 ± 0.67
F = 0.76, p = 0.38
2.32 ± 0.43
1YR (n = 37) mean ± SD
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J Community Health Table 4 Intent-to-treat analysis for dietary, physical activity and clinincal outcomes Post intervention EI Effect size (CI)
1 year MI Effect size (CI)
EI Effect size (CI)
MI Effect size (CI)
-0.11 (-0.40, 0.18) -0.15 (-0.44, 0.14)
-0.27 (-0.56, 0.02) -0.46 (-0.76, -0.17)
-0.20 (-0.49, 0.09) -0.09 (-0.38, 0.20)
-0.01 (-0.30, 0.28)
0.12 (-0.17, 0.42)
-0.14 (-0.43, 0.16)
Dietary intake measures Fat and Fiber Questionnaire (FAFQ summary scales)a Dietary fat Dietary fiber
-0.43 (-0.73, -0.14) -0.52 (-0.82, -0.22)
NCI fruit and vegetable screener (servings/day) Fruit and vegetables
0.21 (-0.09, 0.50)
Physical activity measures (hours/week) All physical activity
0.64 (0.34, 0.94)
0.44 (0.14, 0.73)
0.27 (-0.03, 0.56)
0.28 (-0.02, 0.57)
Moderate intensity
0.71 (0.40, 1.01)
0.32 (0.02, 0.61)
0.30 (0.01, 0.60)
0.17 (-0.12, 0.46)
Clinical measures Systolic blood pressure (mmHg)
-0.21 (-0.50, 0.08)
-0.35 (-0.65, -0.06)
-0.47 (-0.76, -0.17)
-0.03 (-0.32, 0.26)
Diastolic blood pressure (mmHg)
-0.14 (-0.43, 0.15)
-0.48 (-0.77, -0.18)
-0.21 (-0.51, 0.08)
0.11 (-0.19, 0.4)
Total blood cholesterol (mg/dL)
-0.14 (-0.43, 0.15)
-0.20 (-0.49, 0.10)
-0.07 (-0.36, 0.22)
-0.13 (-0.42, 0.17)
LDL blood cholesterol (mg/dL)
-0.15 (-0.44, 0.15)
-0.20 (-0.49, 0.10)
-0.02 (-0.31, 0.27)
-0.25 (-0.55, 0.04)
Blood glucose (mg/dL)
-0.15 (-0.44, 0.15)
-0.16 (-0.45, 0.13)
-0.29 (-0.59, 0.00)
-0.36 (-0.65, -0.06)
BMI (kg/m2)
-0.27 (-0.56, 0.02)
-0.18 (-0.48, 0.11)
-0.34 (-0.63, -0.05)
-0.05 (-0.35, 0.24)
Effect sizes reported as Cohen’s d statistic a
FAFQ Questionnaire scores range from 1 to 4. A score of 1 represents the lowest fat and highest fiber eating behaviors
demonstrates how baseline dietary intake could be used to modify the intervention. For example, if participants are meeting recommendations for fruit and vegetable intake, more time could be spent on lowering dietary fat intake. EI participants had greater success at improving their levels of physical activity than MI participants. Similar results have been reported by WISEWOMAN programs in California and Arizona [27–29]. Changes for both moderate and total physical activity among the EI group were statistically significant at post-intervention, and moderate effect sizes showed that there was a meaningful increase in the actual number of minutes of both types of activity. This indicates that participants in the EI were successful in achieving greater levels of physical activity because of the knowledge, skills and support they received through the IWP intervention. These changes were larger for the Spanish speaking sample than for the English speaking sample [11]. However, by 1 year, activity levels were similar to baseline, suggesting the need to find better long term solutions to help this population overcome barriers to physical activity. IWP may draw on lessons from the Arizona and California WISEWOMAN programs, which had greater success after 1 year. Those programs included follow-up informational sessions beyond the time of the initial intervention, and incorporated multiple levels of education and support. Participants in the EI group showed a significant reduction in BMI levels which are parallel to the increase
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in physical activity levels. This reduction in BMI moved women from the obese category to the range defined as overweight. This degree of change in BMI levels was not seen in the English speaking sample as has been reported before [11]. The timeline of changes in the EI group is consistent with the fact that behavioral changes can be measured in the short-term, but changes in clinical measures take longer to manifest. So while diet and physical activity measures showed improvements at post-intervention, the change in BMI was not seen until the 1-year follow-up. Marginal improvement was seen in diastolic and systolic blood pressure, for the MI group at post-intervention, but it was not sustained at 1 year. This may demonstrate that participants were initially motivated to make lifestyle changes because of participation in the baseline screenings and the educational materials provided. However, it appears these steps were not adequate for producing long term change, reinforcing the need to incorporate more measures to sustain behavior changes, such as those used in Arizona and California. This program targets underinsured and uninsured women enrolled in the IBCCP, a population that is at risk for CVD. As with most community-based studies, we were not able to randomly select women from the general population to meet our inclusion criteria, so our sample is not generalizable to the general population but may reasonably be generalized to women with characteristics similar to
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study participants. Strengths of the study include its use of intermediate behavioral outcomes and long-term clinical outcomes and the success of randomization, as participants in the two groups showed no differences in demographic characteristics or clinical measures at baseline. Recruitment and retention of participants was a challenge in this study. Participants in the EI group had higher rates of attrition than the MI group at post-intervention, although the rates were similar at the 1-year follow-up. However, since participants were randomly assigned to intervention groups, it is more likely that attrition is a result of the length of the intervention rather than participant characteristics. Overall, there were no differences between the completers and non-completers in the MI group. EI participants who completed the intervention had a lower income, higher levels of cholesterol and lower physical activity levels than the non-completers. These findings suggest that low-income women with a high-risk for CVD maybe more motivated to improve behaviors and hence targeting them may improve retention. The pilot test clearly showed that support from family was critical to participation in this population. Future implementations should consider ways to further involve the family in the intervention. System issues that affect attendance such as transportation and childcare should also be considered.
Conclusion The IWP Spanish-language arm was moderately successful in addressing risk factors for CVD in this population. The longest lasting impacts of the program appear to have been an increase in fiber intake and a decrease in BMI. Findings suggest that adaptations made to the IWP based on the results of the pilot test contributed to the positive changes that have been demonstrated in the intervention group. Future implementations may benefit from further tailoring of the program to this population, and learning from the successes of Spanish-language WISEWOMAN programs in other states. Acknowledgments We are very grateful for the leadership of Sharon Green and Pamela W. Balmer from the Illinois Department of Public Health. We thank Katie Zinn for her extensive work developing the protocol, and LaRhonda Williams for early leadership of this program. We respect the hard work and commitment of the staff at DuPage, Fulton, and Stephenson County Health Departments, Mercy Hospital, and St. Mary’s Hospital for implementing this program. We appreciate the assistance of Ruth Ann Carpenter, Heather Chambliss and Rachel Huber in the development of the original curriculum materials, and Susan Auger for her helpful guidance with tailoring the curriculum to better serve the needs of the target population. We thank Melida Colindres and Rosario Montoya for translating and back-translating the curriculum and facilitator
materials. Finally, we greatly appreciate the study participants for their time and dedication to the Illinois WISEWOMAN Program. This research was funded by CDC Cooperative Agreement Number U58/CCU522815. Conflict of interest
None.
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