Abstract
BackgroundStudies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. However, research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. The aim was to design a culturally adapted lifestyle intervention for an immigrant population and to evaluate its effectiveness and cost-effectiveness.Methods/designIn 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.DiscussionThis study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will also assess its cost-effectiveness. Results from this trial may help health care providers and policy makers to adapt and implement lifestyle interventions suitable for this population group that can be conducted in the community.Trial registrationClinicalTrials.gov, NCT01420198
Highlights
Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients
This study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will assess its cost-effectiveness
This article presents a detailed description of a culturally adapted randomized controlled trial of a lifestyle intervention, whose effectiveness in combating risk factors for Type 2 diabetes (T2D) and cost-effectiveness we will investigate in Iraqi immigrants
Summary
Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. Research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. In 2010, a pilot survey of almost 200 residents of Rosengård in Malmö who were born in Iraq or Sweden revealed a very high prevalence of T2D (20%), independent of country of birth, perhaps as a result of the study having been conducted in a socioeconomically vulnerable area [7]. Preliminary results obtained by June 2012 show that the prevalence of T2D is twice as high in Iraqi immigrants (n = 898) compared to Swedish participants (n = 757) (12.4% vs 5.9%, p < 0.001), and that risk factors for T2D, such as family history of diabetes (52%), physical inactivity (64%) and obesity (38%), cluster in Iraqi subjects (manuscript submitted November 2012)
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