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Open Access Study protocol

A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmö): study protocol for a randomized controlled trial

Sanjib Saha12, Matti Leijon2, Ulf Gerdtham123, Kristina Sundquist24, Jan Sundquist24, Daniel Arvidsson2 and Louise Bennet2*

Author Affiliations

1 Health Economics and Management, Institute of Economic Research, Lund University, Lund, Sweden

2 Department of Clinical Sciences, Center for Primary Health Care Research, Lund University/Region Skåne, Skåne University Hospital, Building 60, floor 12 Jan Waldenströms gata 37, 205 02 Malmö, Sweden

3 Department of Economics, Lund University, Lund, Sweden

4 Stanford Prevention Research Center, Stanford University School of Medicine, Palo Alto, CA, USA

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Trials 2013, 14:279  doi:10.1186/1745-6215-14-279

Published: 3 September 2013

Abstract

Background

Studies 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/design

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.

Discussion

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 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 registration

ClinicalTrials.gov, NCT01420198