一项针对有糖尿病风险的中东移民人群的文化适应性生活方式干预措施，即MEDIM（马尔默市移民与种族对糖尿病的影响）：一项随机对照试验的研究方案。
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.
作者信息
Saha Sanjib, Leijon Matti, Gerdtham Ulf, Sundquist Kristina, Sundquist Jan, Arvidsson Daniel, Bennet Louise
机构信息
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.
出版信息
Trials. 2013 Sep 3;14:279. doi: 10.1186/1745-6215-14-279.
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.
背景
研究表明，生活方式干预对于预防或延缓高危患者2型糖尿病的发病有效。然而，针对具有不同文化和社会经济背景的高危移民人群开展生活方式干预有效性的研究却很匮乏。本研究旨在为移民人群设计一种文化适应型生活方式干预方案，并评估其有效性和成本效益。
方法/设计：在这项随机对照试验中，308名参与者（出生于伊拉克，居住在瑞典马尔默，且有2型糖尿病高危风险）将被随机分配至文化适应型干预组或对照组。干预措施包括在6个月内进行10次聚焦于饮食、体育活动和行为改变的小组咨询，并提供锻炼课程。文化适应包括针对性别的锻炼课程以及由健康教练社区成员提供咨询服务。对照组将接受初级卫生保健中心提供的关于健康生活方式习惯的信息。主要结局指标为空腹血糖水平的变化。次要结局指标包括体重指数、胰岛素敏感性、体育活动、饮食习惯以及健康相关生活质量的变化。在基线、3个月和6个月时进行测量。数据将采用意向性分析方法进行分析。将从患者、卫生保健和社会角度通过模拟建模评估试验期间及长期的成本效益。
讨论
本研究将为衡量针对中东移民设计的生活方式干预在改善糖代谢方面的有效性提供依据，同时也将评估其成本效益。本试验结果可能有助于卫生保健提供者和政策制定者调整并实施适合该人群且可在社区开展的生活方式干预措施。
试验注册
ClinicalTrials.gov，NCT01420198。
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