Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.

Study Overview
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Brief Summary
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An increasing proportion of Sweden's population comprises non-European immigrants, who constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi citizens represent the largest immigrant group in Malmoe and are identified as a risk group for Type 2 Diabetes (T2D) in whom genetic and lifestyle factors probably play significant roles in the development of T2D. Several studies have shown that adoption of an active lifestyle by at-risk individuals dramatically reduces the risk of T2D. However, there are currently no established methods for providing support to high-risk individuals from different cultural and social backgrounds to help them adopt beneficial lasting lifestyle changes. Instead of just waiting for Iraqi high-risk individuals to develop T2D, this project will implement and assess lifestyle intervention programs aimed at reducing the risk of developing T2D and tailored to individuals with a different social and cultural background. The study thus seeks to optimize preventive action in health care and aims to facilitate the adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural and social barriers. Since T2D is associated with a sedentary lifestyle and develops earlier in men than women and an average 10 years earlier in immigrants from the Middle East than in native Swedes, it is crucial to study pathogenic mechanisms triggering T2D development in relation to sex, lifestyle and ethnic background. The results will provide the basis for deciding how health care providers can actively work to prevent T2D and other lifestyle-associated diseases in this high-risk population that has not been studied before.

Detailed Description
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In this randomized controlled trial, 308 participants (born in Iraq, living in Malmö, Sweden and at high risk of type 2 diabetes) will be allocated to either a culturally adapted intervention or a control group. The intervention will consist of 10 group counseling sessions focusing on diet, physical activity and behavioral change over 6 months, and the offer of exercise sessions. Cultural adaptation includes gender-specific exercise sessions, and counseling by a health coach community member. The control group will receive the information about healthy lifestyle habits provided by the primary health care center. The primary outcome is change in fasting glucose level. Secondary outcomes are changes in body mass index, insulin sensitivity,physical activity, food habits and health-related quality of life. Measurements will be taken at baseline, after 3 and 6 months. Data will be analyzed by the intention-to-treat approach. The cost-effectiveness during the trial period and over the longer term will be assessed by simulation modeling from patient, health care and societal perspectives.

Official Title
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A Middle Eastern Immigrant Population At-risk for Diabetes; Contributing Risk Factors and the Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.

Conditions
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Type 2 Diabetes, Impaired Glucose Tolerance, Obesity, Physical Activity

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) 30 to 75 years of age (2) individuals in the baseline survey diagnosed with prediabetes. OR BMI ≥ 28 kg/m2 OR waist >=80 cm in females and >=94cm in males. Exclusion Criteria: pregnancy, severe mental illness, diabetes, and/or cognitive impairment, current CVD or history of CVD events. CVD includes stroke, angina or myocardial infarction (MI), percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (CHF), coronary artery bypass graft surgery (CABG), transient ischemic attack (TIA) and peripheral vascular disease (PVD) or other physical disorders that prevent physical exercise.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>Lifestyle intervention: 500 participants from Iraq with obesity and/or prediabetes (impaired fasting glucose) and we expect to recruit 308 participants. Half of them will be randomized to lifestyle intervention i.e. group counseling and physical activity during a period of 1 year. An equal amount of controls will have treatment as usual. Every third month blood tests and a physical exam will be conducted in the intervention group. | Behavioral: Lifestyle intervention<br>* Increased physical activity and improved food habits<br>|
| No Intervention: Controls<br>Controls have treatment as usual. Every third month blood tests and a physical exam will be conducted in the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | measured by study nurses | 4 months | 
| Physical activity | self-reported | 4 months | 
| Caloric intake | from food records | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QALY | The effectiveness will be measured as change in health related quality in life measures as Quality adjusted life years (QALY) | 4 month | 
| Glycemic changes | fasting glucose, 2-hr glucose | 4 month | 
| HbA1C |  | 4 month | 
| Insulin sensitivity and secretion | insulin sensitivity index and disposition index | 4 month | 
| Blood lipid profile | LDL, HDL, trilycerides | 4 month | 
| Blood pressure | systolic and diastolic | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes type 2, Lifestyle intervention, QALY, Ethnic group, Impaired glucose tolerance, Impaired fasting glucose