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Contents lists available at ScienceDirect

Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd

Original research

Diabetes prevention program in a Mediterranean environment: Individual or group therapy? An effectiveness evaluation R. Endevelt a,b , R. Peled c,∗ , A. Azrad a , G. Kowen a , L. Valinsky d , A.D. Heymann e a

Health Promotion and Preventive Medicine, Maccabi Health Organization, Israel School of Public Health, Haifa University, Haifa, Israel c Health Systems Management, Ben Gurion University of the Negev, Beer Sheva, Israel d Department of Clinical Quality, Meuhedet Health Organization, Tel Aviv, Israel e Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel b

a r t i c l e

i n f o

a b s t r a c t

Article history:

Introduction: Diabetes as a multifactorial disorder requires prevention measures based

Received 23 February 2014

upon the modification of several risk factors simultaneously; otherwise, there is insufficient

Received in revised form

potential for prevention. Following the success of the American Diabetes Prevention Program

30 June 2014

(DPP), we implemented an intervention program in a large Israeli healthcare organization

Accepted 13 July 2014

with an emphasize on Mediterranean Diet (MedDiet) and physical activity.

Available online xxx

The objective was to evaluate the effectiveness of two types of intervention, individual and group therapies, in reducing risk factors and in preventing or delaying the development

Keywords:

of type 2 diabetes.

Diabetes prevention

Methods: Out of 180 primary care physicians, 85 who agreed to participate, were randomly

Pre diabetes intervention

assigned, between the years 2005 and 2006, into two groups: those who would refer pre-

Individual therapy

diabetes adult patients for individual therapy and those who would refer for group therapy.

Group therapy

The two groups of patients consisted of 111 and 112 in each group. The intervention lasted for 6 months and discussed: the benefits of MedDiet, planning nutritional behavior and mindful eating, and the importance of physical activity. All patients were invited to participate in walking groups. Follow up lasted for 24 months and logistic, mixed models, and Cox regressions were employed. Results: No statistically significant differences were detected between the two intervention groups in age; gender and clinical measurements at recruitment. Thirty nine percent of both groups developed diabetes (entered the DR by 2012), including 38.7% from the individual therapy and 39.3% from the group therapy (P = 0.933). The mean time from 2005 until entry to the Diabetes Registry (DR) was 2.9 and 2.5 years for the individual and group therapy respectively (P = 0.542).



Corresponding author. E-mail address: [email protected] (R. Peled). http://dx.doi.org/10.1016/j.pcd.2014.07.005 1751-9918/© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: R. Endevelt, et al., Diabetes prevention program in a Mediterranean environment: Individual or group therapy? An effectiveness evaluation, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.07.005

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Conclusion: Both interventions were equally effective in achieving the desired outcomes and time until entry to the DR. For large health organizations with a high number of prediabetes patients and scarce resources, group therapy, where 12 people are reached out by one team member are preferable and more costly effective, than a one on one therapy. © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

1.

Background

Diabetes is a major health problem worldwide, and according to the World Health Organization’s statistics, the incidence, prevalence, and mortality associated with the disease are consistently increasing [1]. Given its chronic nature, severe complications and long-term care requirements, diabetes has become an economic and social burden. Since diabetes is a heterogeneous and multifactorial disorder, it is suggested that prevention measures should be based upon the modification of several risk factors simultaneously; otherwise, there is insufficient potential for prevention. The well-known risk factors are moderate levels of blood glucose, hypertension, lack of physical activity, obesity, and poor nutrition in addition to medical and family history [2]. The American Diabetes Prevention Program (DPP) [3] is a successful program that demonstrated a reduction of 58% in the incidence of diabetes with lifestyle modifications and a 31% reduction with medication (Metformin) as compared to placebo. The lifestyle modifications included individual sessions for encouraging healthy diet habits, weight loss, and an increase in physical activity. Following the success of the American DPP, similar interventions were implemented in Australia [4], Europe and other parts of America, with an ethnic sensitive approach [5] and for wider population groups [6]. Maccabi Healthcare Services (MHS) is the second largest Health Maintenance Organization (HMO) in Israel, providing primary care to 1.9 million residents nationwide through five administrative and geographical regions. Physicians are employed in solo practices, and beneficiaries have free choice in regard to their own care-givers. The turnover between HMOs is relatively small, and beneficiaries tend to stay with their providers for a long period of time [7]. Thus, MHS stresses health promotion and invests significant resources in preventive care. Among MHS beneficiaries, in 2005 82,000 (4.5%) were diabetic patients and recorded as such in the Diabetes Registry (DR), and 186,000 (9.7%) were considered as pre-diabetic according to their levels of fasting glucose (95–125 mg%). The Sharon region was selected for the intervention with relatively high number of pre diabetes patients – 35,000 (9%). MHS’ intervention was based on the core principles of the American DPP, with the goal of reducing weight, blood glucose, LDL cholesterol, and HbA1 C measures and increasing HDL by modifications in diet, mainly into Mediterranean Diet (MedDiet), and physical activity. The advantages of MedDiet are well documented in the scientific literature [8,9]. It is characterized by (i) a high consumption of vegetables, legumes, fruits, and cereals; (ii) a regular but moderate wine intake; (iii) moderate consumption

of fish; (iv) low consumption of meat; and (v) low-to-moderate intake of low fat dairy products and (vi) nuts. Besides being a dietary pattern, the MedDiet is associated with a specific lifestyle with a moderate-to-high level of physical activity and the daily, high consumption of water [10]. Strategies to modify lifestyle behavior, in order to reduce the risk for developing chronic disease have been presented by previous studies over the years. They range from personal medical advice and check up [11]; individual diet consulting; circuit type resistance training sessions and advice on increasing physical activity to reduce weight [12]; commercial weight loss programs [13]; self-weighing and self-management of diet [14] and group therapies to encourage healthy diet and moderate-intensity physical activity [15]. However there is insufficient agreement which strategy is the most effective and the most cost benefit. Our hypothesis was that both individual and group therapy could be equally effective in preventing or delaying the development of type 2 diabetes. For health organizations, in periods of scarce resources, it is crucial to identify the ultimate intervention strategies to outreach large population groups with less investment of resources, not on the expense of achieving the goal of reducing risk factors. Therefore, the objective of this study was to evaluate the effectiveness of the two types of MHS’ DPP, in reducing risk factors and in preventing or delaying the development of type 2 diabetes.

2.

Methods

2.1.

Setting

The intervention was implemented in the central (Sharon) region of the country, where primary care is delivered to 380,000 beneficiaries.

2.2.

Study population

Between the years 2005 and 2006, the MHS physicians (180) in the Sharon region were invited to a series of lectures to present the intervention program on enhancing healthy diet and physical activity habits. Eighty-five of them agreed to participate and were randomly assigned into two groups: (1) those who would refer/recruit pre-diabetes adult patients (40–65 years of age) for individual therapy and (2) those who would refer/recruit pre-diabetes adult patients for group therapy (Graph 1). Patients who participated at least in 80% of the intervention activities were included in the analysis.

Please cite this article in press as: R. Endevelt, et al., Diabetes prevention program in a Mediterranean environment: Individual or group therapy? An effectiveness evaluation, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.07.005

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2.6. 85 phys. agreed to parcipate

180 phys. aended the meengs

3,194 invitaons were sent

3

The intervention

The aim of the intervention was to modify participants’ diet habits mainly by the adoption of the low calorie MedDiet, changing eating behavior and increasing physical activity, to lower weight and improve biochemical outcomes to postpone Diabetes. The overweight and obese patients received tailored program to reduce weigh. Others received instructions diet consisted on 1500 calories per day.

2.6.1.

Recruitment

Letters of invitation were sent by the physicians to eligible patients, describing the aims and scope of the intervention with an emphasis on the importance of reducing the risk factors for type 2 diabetes. In addition, for either the individual or group therapy, the subjects to be on the agenda were presented.

3,173 met their physicians

223 paents agreed to parcipate

2.6.2.

Ethics

Approval for the intervention was received by the local ethics committee, and each participant signed an informed consent. Participation was free of charge. 112 Group

111 Individual

Graph 1 – Patients recruitment flow chart.

2.6.3.

Personnel

The team participating in the intervention included 82 physicians; 20 dieticians; five physiotherapists; four social workers; five physical activity trainers and consultants; and three coordinators.

2.6.4. Meetings structures 2.6.4.1. The group therapy. Each group consisted of 12 men 2.3.

Definition

Patients were considered to be pre-diabetic if the last impaired fasting glucose test was between 110 and 125 mg% or the impaired glucose tolerance test (OGTT) was between 140 and 199 mg% or the Body Mass Index (BMI) was >27, in addition to at least one risk factor (family history of diabetes; gestational diabetes; hypertension; HDL < 35 mg%) and no record in the MHS DR between the years 2005 and 2006.

2.4.

Exclusion criteria

Patients with cancer or liver disease; mental or cognitive impairment; as recorded in the MHS DR at recruitment.

2.5.

Data sources

MHS computerized system. Clinical information included fasting glucose tests, total cholesterol, HDL and LDL cholesterol, triglycerides, and BMI. Personal information included age at recruitment and gender. For both intervention groups, all measures were taken at three points in time: before the intervention (baseline = T1); at the end of the intervention (after 6 months = T2); and 18 months after the end of the intervention (T3). Additionally, we used MHS DR as a source for the identification of patients who developed diabetes by 2012 (6 years of follow up).

and women, who had ten meetings, of 90 min, each over a period of 6 months with a trained dietician, a social worker, a general practitioner, and a physical activity consultant, in addition to a “walking group” twice a week. The items on the agenda included the benefits of MedDiet, (planning nutritional behavior and mindful eating, and the importance of physical activity.

2.6.4.2. The individual therapy. Individual therapy consisted of eight meetings of 30 min, over a period of 6 months with a trained dietician, in addition to a “walking group” twice a week and a physical activity and social worker consultant if needed. The subjects on the agenda were the same as for the group treatment.

2.7.

Statistical analysis

Univariant techniques (T-test or Chi Square) were employed in order to describe the study population. Since we had an unbalanced design of repeated measures, we applied mixed linear models. The dependent variables were glucose; total cholesterol; HDL cholesterol; LDL cholesterol; triglycerides; and BMI. The independent fixed factors were time of measurement (T1 = baseline before intervention, T2 = immediately after intervention, and T3 = after 18 months) and study group (1 = individual treatment; 0 = group treatment). Subjects were entered into the model as a random factor (since we had repeated measures for each subject). For each dependent variable, we established two models. In the first model, we

Please cite this article in press as: R. Endevelt, et al., Diabetes prevention program in a Mediterranean environment: Individual or group therapy? An effectiveness evaluation, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.07.005

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Table 1 – Intervention group characteristics. Variable At recruitment Mean age % Females Mean BMI Mean glucose (mg%) Mean cholesterol (mg/dl) Mean HDL Chol (mg/dl) Mean LDL Chol (mg/dl) Mean TG (mg/dl) In 2012 % Entered DR by 2012 Mean time from 2005 to DR entry (year) †

Individual Therapy N = 111

Group Therapy N = 112

P value

51.9 (7.6)† 47.7 29.8 (4.3) 111.9 (9.0) 213.7 (35.3) 47.1 (11.0) 132.7 (30.3) 179.1 (96.3)

55.4 (6.9) 48.2 30.8 (4.4) 111.8 (9.2) 207.6 (38.7) 48.2 (12.6) 128.8 (30.9) 167.7 (109.8

Diabetes prevention program in a Mediterranean environment: individual or group therapy? An effectiveness evaluation.

Diabetes as a multifactorial disorder requires prevention measures based upon the modification of several risk factors simultaneously; otherwise, ther...
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