Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.
Condition: Type 2 Diabetes; Impaired Glucose Tolerance; Obesity; Physical Activity
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Increased physical activity and improved food habits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes type 2; Lifestyle intervention; QALY; Ethnic group; Impaired glucose tolerance; Impaired fasting glucose