Community Ment Health J DOI 10.1007/s10597-014-9716-9


A 12-Week Weight Reduction Intervention for Overweight Individuals Taking Antipsychotic Medications Carla A. Green • Shannon L. Janoff • Bobbi Jo H. Yarborough • Micah T. Yarborough

Received: 4 June 2013 / Accepted: 16 February 2014 Ó Springer Science+Business Media New York 2014

Abstract People taking antipsychotic medications are at increased risk for obesity, diabetes, and early mortality. Few weight loss interventions have targeted this population. Thirty-six individuals were randomized to an evidence-based 12-week weight loss intervention (PREMIER with DASH diet, n = 18) or to usual care (n = 18) in this feasibility trial. Average attendance was 8.6 of 12 sessions. Intent-to-treat analyses of covariance, adjusted for baseline weight, showed significant changes in weight: Mean weight in intervention participants declined from 213.3 to 206.6 pounds, while control participants’ weight was unchanged. It is possible to recruit, assess, intervene with, and retain participants taking antipsychotic medications in a dietary and exercise lifestyle change trial. Participants reported high levels of satisfaction with the intervention. Keywords Weight loss  Weight reduction  Exercise  Antipsychotic medications  Serious mental illness

Introduction Overweight and obesity are among the leading causes of preventable deaths in the US, primarily through their effects on cardiovascular disease (CVD) risk factors, including Type II diabetes mellitus (Eeg-Olofsson et al. 2009; Wang et al. 2011). Compared with the general population, individuals with serious mental illnesses, regardless of antipsychotic use (Ryan et al. 2003; Thakore

C. A. Green (&)  S. L. Janoff  B. J. H. Yarborough  M. T. Yarborough Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Ave, Portland, OR 97227-1110, USA e-mail: [email protected]

2004), are at greater risk of obesity, diabetes and CVD, and subsequent early mortality (Kilbourne et al. 2009; Crump et al. 2013; Allison et al. 2009; De Hert et al. 2009; Druss et al. 2011). Among those taking antipsychotic medications, iatrogenic weight gain and sedation further challenge obesity management efforts (American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, and North American Association for the Study of Obesity 2004; Allison et al. 1999; Allison and Casey 2001; Schwartz et al. 2004; Ganguli 1999; Keck and McElroy 2003; McIntyre et al. 2005; Cohen 2004). In addition, weight gain undermines mental health treatment outcomes because people are more likely to discontinue antipsychotic treatment if they experience weight increases (Weiden et al. 2004). Obesity also negatively affects quality of life (Kushner and Foster 2000; Strassnig et al. 2003), and obese individuals experience more interpersonal and institutional discrimination and have lower levels of self-acceptance than normal-weight persons (Carr and Friedman 2005). In this already-stigmatized population, obesity is likely to negatively affect social interaction and increase social isolation. Increasing evidence suggests that lifestyle interventions aimed at reducing cardiovascular risks through increasing fitness (Bartels et al. 2013) and decreasing weight (Daumit et al. 2013) can be effective and feasible among people with mental illnesses. The Weight Management Pilot study was conducted to determine the acceptability and feasibility of an efficacious outpatient weight loss intervention—the evidence-based PREMIER intervention with DASH diet (Ard et al. 2004; Funk et al. 2006; Obarzanek et al. 2001; Appel et al. 2003)—translated for individuals taking antipsychotic medications. PREMIER was a randomized multicenter study of three lifestyle interventions for people with elevated blood pressure; one of the


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intervention arms included the DASH diet. PREMIER with DASH diet promoted weight loss and reduced obesityrelated risks, including diabetes risk, through moderate calorie reduction, dietary changes, and increased energy expenditure. Intervention targets were based on current clinical practice guidelines established for obesity treatment and for individuals at increased risk for CVD (National Institutes of Health 1997; Expert Panel on Detection 2001; NHLBI Obesity Education Initiative Expert Panel 1998). The intervention built upon motivation and behavior change theories to enhance self-efficacy and promote long-term behavior change (Appel et al. 1997; Prochaska and DiClemente 1983; Bock et al. 2001; Miller and Rollnick 1991; Rollnick et al. 1999; Bandura 1986; Bandura and Adams 1977). The primary aims of this study were to test acceptability and feasibility of the PREMIER/DASH Diet intervention among people taking antipsychotic medications. A secondary, exploratory, aim was to test the hypothesis that the intervention was more effective than usual care in reducing weight at 3 months and in improving body image/selfesteem, increasing family and friend support for dietary or exercise changes, and building confidence in changing diet or exercise practices. Planned statistical analyses were exploratory, based on intent-to-treat principles, and examined differences in change scores between control and intervention groups using analyses of variance/covariance. Analyses of intervention effectiveness on weight controlled for baseline values to account for differences in ease of weight loss associated with baseline obesity level.

Methods Recruitment and Randomization This randomized feasibility trial was conducted within a large, not-for-profit, integrated health plan (Health Plan Name, Acronym) in the (US Region). We used the health plan’s electronic medical record data to identify overweight and obese (BMI of 25–44.9) adults aged [18 years who had been taking at least one antipsychotic medication at any consistent dose for a minimum of 30 days at the time they were identified; participants could be taking multiple antipsychotics. We kept exclusion criteria to a minimum to increase clinical relevance and broaden the eligible population, thus individuals were excluded only if they were unable to read/speak English; self-reported an inpatient psychiatric hospitalization within 30 days prior to enrollment; reported a serious illness with increased risk for weight loss (potential confound) or a medical contraindication to weight loss (e.g., cancer, pregnancy/breastfeeding); or were already participating in another weight


Fig. 1 Consort diagram

reduction program. With the prescribing clinicians’ approval, we mailed each individual a recruitment letter explaining the purpose of the study and requirements for participation. Individuals were asked to call the study to indicate interest; master’s-level study staff telephoned individuals who did not respond to the letter until we achieved our target sample size. Up to eight call attempts were made for each non-responder. Interested individuals were invited to attend a group orientation visit where they could learn more about the study, complete a baseline questionnaire, and enroll in the trial. Those enrolled were randomized to the intervention or usual care control condition, using a randomly generated assignment table stratified on gender and BMI (25–34.99 or 35–44.99). Study interventionists informed participants of their randomization status in order to keep data collection staff blind to treatment assignment. Participants were given a $25 gift certificate to a local one-stop shopping chain as compensation for questionnaire completion; incentives were not provided for intervention sessions. KPNW’s Research Subjects Protection Office approved and monitored all procedures including informed consent forms and processes; the authors do not have any conflicts

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of interest to report and certify their responsibility for this manuscript.

Table 1 Intervention session content Session


Recruitment Outcomes


Orientation to the study and materials, beginning discussion of self-monitoring

We identified 738 individuals who were likely to meet study criteria and sent 561 letters (76 %) to clinicians for signature approval. Clinicians signed and returned 422 (75 %) recruitment letters, which we mailed to potential participants. After attempting to contact 29 % of potential participants (n = 121) we met our study target for recruitment. Among those contacted, 60 (50 %) screened eligible for the study and 38 (63 %) attended orientation visits. In all, 36 individuals were randomly assigned to intervention (n = 18) or control (n = 18) groups. See Fig. 1 for additional details.


Using food and physical activity records, looking at sources of calories and reading nutrition labels, beginning to look at portion sizes


Portion sizes, using food records (specifically looking at portions and fruit and vegetable servings)


Commonly eaten foods, individual physical activity patterns


Managing negative thoughts and negative emotional states, handling vacations


Preparing food, introducing new dinner patterns, environmental triggers for physical activity


Special occasions, alcohol guidelines, exercising during busy times


Conscious eating, snacking patterns, benefits of exercise, dealing with cravings


Using family support to achieve goals, food for the family, physical activity with your family


Managing stress, portion estimation


Exercising to keep the weight off, ensuring exercise gets done


Celebrating accomplishments, planning for support for weight management

Description of the Intervention The PREMIER study (Appel et al. 2003) was a randomized multicenter study of participants with elevated blood pressure that tested three lifestyle interventions: (1) advice only; (2) behavioral intervention based on established recommendations regarding weight loss, sodium reduction, and increased physical activity; and (3) behavioral intervention plus the DASH diet. The DASH diet emphasizes increased intake of fruits, vegetables, and low-fat dairy products, and promotes consumption of whole grains and lean sources of protein such as fish and poultry while encouraging reductions in dietary sodium. Goals of the intervention include moderate calorie restriction; increases in moderate exercise; increases in fruit, vegetables, and low-fat dairy products; and daily use of a food diary. Our group intervention provided education and encouragement to make lifestyle changes consistent with the PREMIER intervention; few changes were made to intervention content. Modifications were made in the delivery of the intervention, however. First, a key adaptation was the use of a co-leader model that included one specialist in weight loss behavior change and one specialist in mental health counseling. Another important adaptation was to adjust the pace of the intervention to address potential cognitive and executive functioning impairments associated with serious mental illnesses. For example, to facilitate learning and memory, information and tasks were broken into smaller components when necessary; group leaders were trained to use clear, concise language and concrete examples; to use repetition; to confirm reception and accurate interpretation by asking participants to repeat back what they have been told; to liberally employ visual aides and, whenever possible, to use interactive learning techniques (e.g., role plays, home

practice assignments) rather than didactic approaches. Finally, the intervention allowed for family members to attend group sessions in order to gain knowledge so they could support participants’ lifestyle change efforts. All sessions were structured to present new information at the beginning of the group session, to break for a walk on the surrounding campus, and to conclude with a discussion meant to consolidate learning. Sessions were 2 h in length, including a half-hour walk. Individual session content is described in Table 1. Participants were taught how to complete food and exercise diaries and were encouraged to keep them throughout the intervention. Completed diaries were reviewed by counselors who then provided tailored, individual-level feedback at the subsequent meeting. Weighins preceded each group meeting. Participants who missed scheduled meetings were contacted and individual makeup sessions were held by telephone or at the research center. The final meeting included a pot-luck dinner; participants were encouraged to prepare and bring healthy items that had helped them change their dietary habits. Participants completed short evaluations following each group meeting. Usual care participants did not participate in the weekly groups, nor were they given any additional nutritional, exercise, or lifestyle advice or food diaries. Usual care participants completed assessments only.


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Measures Height, weight, and blood pressure were measured by blinded study staff; participants were clothed without shoes. Height was measured in inches using a wallmounted stadiometer. Weight was measured on a digital scale and rounded to the nearest hundredth of a pound. Blood pressure was measured by digital sphygmomanometry. Participants with elevated blood pressure values were referred to primary or emergency care (as appropriate) and followed-up by study staff. Intervention and control participants completed study questionnaires at baseline and post-treatment (13 weeks follow-up). Questionnaires included: Eating Habits Confidence and Exercise Confidence questionnaires (Sallis et al. 1988), the Social Support Scale for Eating and Exercise Behavior (Sallis et al. 1987), and the Wisconsin Quality of Life Index Medication Adherence items (Diamond and Becker 1999). Information regarding psychiatric medications was also collected as part of the questionnaire, including medication names and doses. Intervention participants maintained food and exercise diaries that recorded fruit and vegetable consumption, duration and intensity of exercise, and hours of sleep. In addition, intervention participants completed weekly evaluations following each group session to indicate their level of satisfaction with the intervention’s components (measured on a four point scale from ‘‘not at all satisfied’’ to ‘‘very satisfied’’), what was most and least helpful about the sessions (measured on a four point scale from ‘‘not at all helpful’’ to ‘‘very helpful’’), and ways in which the sessions could be improved (open-ended questions). Scaled items assessed the ‘‘session as a whole,’’ ‘‘topics covered in the session,’’ ‘‘exercises done as part of the group,’’ ‘‘supportiveness of the group,’’ ‘‘overall group atmosphere,’’ and the ‘‘number of people in the group.’’

Results Participants Intervention and control group participants were similar with regard to sociodemographic characteristics, medication types, weight, and BMI. The mean age was 48.5 (SD = 13.3) years, 81 % were female, 72 % were married or living with a partner, and 94 % were white. Participants received income from a variety of sources including paid employment (50 %), disability payments (25 %), retirement income (25 %), spouses and other family members (19 %), and other sources (14 %). The mean weight at baseline was 211 pounds (SD = 39.2), ranging from 150 to 321 pounds; mean BMI was 34.5 (SD = 6.3), ranging from 24.2 to 54.4. Among


participants, 22 (61 %) reported taking atypical antipsychotic medications; 10 (28 %) reported conventional antipsychotic use; 1 (3 %) reported use of both atypical and conventional antipsychotics; 5 (14 %) were taking lithium; and 28 (78 %) were taking antidepressants. Most participants (31; 86.1 %) were taking more than one psychiatric medication (mean = 3.17, SD = 1.57), including antipsychotics, antidepressants, anti-anxiety medications, anticonvulsants, sedatives, and stimulants. One person did not know the name of their prescribed antipsychotic. Information on medication dose is available from the corresponding author, upon request. Most participants (n = 26, 72.2 %) reported always taking medications as prescribed; 9 (25 %) reported taking medications ‘‘quite often’’ as prescribed, and one person (2.8 %) indicated they ‘‘sometimes’’ took them as prescribed. Self-reports of psychiatric medication-related side-effects included 7 (19.4 %) people indicating they never experienced side effects; 15 (41.6 %) reporting slight or mild side effects; 12 (33.3 %) reporting moderate and 2 (5.6 %) reporting severe side-effects. Intervention Attendance Participants attended an average of 8.0 of 12 sessions (67 %; SD = 2.9). Ten individual make-up sessions were provided (1 with each of 6 participants, and 4 with 1 participant). After combining the group and individual sessions, mean attendance was 8.6 of 12 sessions (72 %; SD = 2.8). One participant attended only 1 session; 55.6 % of participants (n = 10) attended 9 or more sessions. Known reasons for non-attendance included a job change, caregiving responsibilities, serious physical injury, and psychiatric hospitalization. Food Diaries Nine intervention participants consistently completed food diaries throughout the 12-weeks; five began keeping them but stopped over time; and two started keeping them midway through the intervention and continued. Satisfaction with the Intervention Comments on the intervention evaluation forms showed enthusiastic support for having the group co-led by a diet/ exercise behavior change specialist and a mental health counselor. Participants were also enthusiastic about the topics discussed and the intervention materials. When participants were asked at 12 weeks to reflect on the overall helpfulness of the group across a variety of domains (topics covered, group exercises, supportiveness of group, and overall group atmosphere), 100 % of last-session attendees (n = 12) indicated the group was either very or

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somewhat helpful to them. No participants reported that the group was not helpful. In addition, all (100 %) reported satisfaction (being either somewhat or very satisfied) across all domains, and were also satisfied with the number of people in the group. Weekly session evaluations paralleled these results. Open-ended questions showed that only one element of the protocol—allowing family members of participants to attend the group meetings—was disliked, and only by a few members of the group. These participants reported feeling uncomfortable sharing their experiences and struggles with non-participants. The following were listed in response to a question about what participants liked best about the group overall (reported by individual participant responses): Portions, eating-out tips, sodium information, handouts; that it was fun; that staff was supportive (three participants); the group atmosphere and professional approach of leaders; calorie tracking and portion control; self-challenge; using food diaries to moderate eating; and group support (two participants). In response to a question asking about how the group sessions could be improved, we received the following suggestions: increase focus on medications and behaviors that can lead to poor eating habits (3 comments); make the program longer than 3 months (3 comments); and good ‘‘as is’’ (2 comments). Post-intervention Results Follow-up assessments were completed with 35 of 36 participants (97 %); the single non-respondent had been assigned to the intervention group, had a baseline BMI just above the lower inclusion point, and had achieved normal weight (BMI \25) at the first intervention session. This participant did not continue in the study and was the only participant lost to follow-up. Baseline weight and BMI were carried forward to follow-up for this individual (i.e., no change was assumed). Mean weight in the intervention group declined from 213.3 to 206.6 pounds, a mean reduction of 6.7 pounds (SD = 6.0), while control group members’ weight was essentially unchanged (209.6 vs. 209.3 pounds), a mean reduction of 0.22 pounds (SD = 6.5). The difference in mean weight at follow-up was 6.5 pounds (standard error of difference = 2.1), which was statistically significant [t = 3.12, df = 34, p = 0.004 (two-tailed)]. ANCOVAs with baseline weight as a covariate yielded similar results, as did analyses in which change in BMI was the outcome variable. Results of analyses of secondary outcomes were somewhat mixed, with net improvements in the intervention group shown in B-WISE body image and self-esteem [mean net difference = -4.97, t = 3.84, df = 33, p = 0.001 (two-tailed)], and family support for exercise changes (mean net difference = -5.62, t = -2.58, df = 29, p = 0.02). We found

no significant net differences in friends’ support for dietary or exercise changes, family support for dietary changes, or participants’ confidence in changing diet or exercise practices.

Discussion In this study, we examined the feasibility and outcomes of a 12-week weight loss and lifestyle intervention among overweight and obese adults taking antipsychotic medications. Feasibility and acceptability assessments indicated that participants were satisfied with intervention content, structure, and group processes. Adaptations in delivery of intervention content were made to aid comprehension among participants with cognitive limitations. We experienced no difficulties in delivering the intervention, in assessing physiological outcomes, or in obtaining responses to questionnaires. Improvements in key outcomes suggest that the intervention increases body image and self-esteem, family support for exercise changes, and that it leads to significant weight loss. These findings suggest that lifestyle interventions can be feasible among individuals with serious mental illnesses even though participants experience day-to-day challenges that affect intervention attendance and take antipsychotic medications that contribute to weight gain and make weight loss more difficult. In particular, it is noteworthy that, despite instability in participants’ lives that resulted in lower attendance than expected or desired, participants were still able to lose significant amounts of weight after only 12 weeks, using a moderate and balanced approach to lifestyle change. Moreover, improvements in body image and self-esteem, and increased family support for exercise have potential to help participants maintain the weight they lost. Finally, the average loss of 6.5 pounds in this study is slightly higher than that reported in a recent systematic review of other weight loss studies in this population (mean weight loss of 5.5 pounds) which included studies with significantly longer intervention periods (Bartels and Desilets 2012). Lastly, our results at 13 weeks are very close to those reported (about seven pounds) following an 18-month intervention in one of the first large scale trials of a behavioral weight loss intervention for persons with serious mental illness (Daumit et al. 2013). Limitations Limitations of this study include its small sample size and limited ethnic diversity. In addition, participants were recruited from an integrated private health plan and thus may not be representative of individuals receiving care in


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community mental health settings. At the same time little research has addressed insured populations with serious mental illnesses, so this is also a contribution of the study. Participants had higher paid employment rates (50 %), lower disability rates (25 %) and were more likely to be married or living with a partner (72 %) than is typical in community mental health clinics, though the higher than average unemployment and disability rates suggest that there is likely substantial overlap with community settings. An additional limitation of the study is that the average number of sessions attended (8.6/12, including makeup sessions) was only about 72 % of available sessions. This rate of attendance is lower than desired, but not surprising given known instability in the lives of people with serious mental illnesses compared to general populations. It is similar, however, to Daumit et al.’s report—participants in that study attended only 63 % of available sessions in the first 6 months (Daumit et al. 2013). Overall, given the small sample size, pilot nature of the study, and the insured population, it would be premature to generalize our results to other populations or settings.

Conclusions The study demonstrated our ability to recruit, assess, intervene with, and retain participants taking antipsychotic medications in a comprehensive lifestyle intervention targeting dietary and exercise change. The net reduction in weight observed in the intervention group is likely to be attributable to the intervention and was achieved over a relatively short time period despite antipsychotic use. Importantly, participants reported high levels of satisfaction with the intervention, though instability in participants’ lives resulted in lower attendance than hoped. Further evaluation of this program in a larger trial is needed.

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A 12-week weight reduction intervention for overweight individuals taking antipsychotic medications.

People taking antipsychotic medications are at increased risk for obesity, diabetes, and early mortality. Few weight loss interventions have targeted ...
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