Department of Medical Psychology, The EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands.
BMC Public Health. 2011 Sep 30;11:751. doi: 10.1186/1471-2458-11-751.
Family history is a known risk factor for type 2 diabetes (T2DM), and more so in the presence of overweight. This study aims to develop and evaluate the effectiveness of a new lifestyle education programme 'DiAlert' targeted at 1st degree relatives of people with T2DM and overweight. In view of the high risk for diabetes and cardiovascular disease in immigrants from Turkish origin living in Western Europe, a culturally appropriate Turkish version of DiAlert will be developed and tested.
METHODS/DESIGN: In this RCT, 268 (134 Dutch and 134 Turkish) overweight 1st degree relatives of patients with T2DM will be allocated to either the intervention or control group (leaflet). The intervention DiAlert aims to promote intrinsic motivation to change lifestyle, and sustain achieved behaviour changes during follow-up. Primary outcome is weight loss. Secondary outcomes include biological, behavioural and psychological indices, along with process indicators. Measurements will take place at baseline and after 3 and 9 months. Changes in outcomes are tested between intervention and control group at 3 months; effects over time are tested within and between both ethnic groups at 3 and 9 months.
The DiAlert intervention is expected to be more effective than the control condition in achieving significant weight loss at 3 months, in both Dutch and Turkish Dutch participants.
Netherlands National Trial Register (NTR): NTR2036.
家族史是 2 型糖尿病（T2DM）的已知危险因素，超重者尤其如此。本研究旨在开发和评估一种针对 T2DM 患者和超重者一级亲属的新的生活方式教育计划“DiAlert”的有效性。鉴于来自土耳其裔的移民在西欧患糖尿病和心血管疾病的风险较高，将开发并测试文化上适宜的土耳其语版 DiAlert。
方法/设计：在这项 RCT 中，将 268 名（134 名荷兰人和 134 名土耳其人）超重的 T2DM 患者的一级亲属分配到干预组或对照组（传单）。干预措施 DiAlert 旨在促进改变生活方式的内在动机，并在随访期间维持已实现的行为改变。主要结局是体重减轻。次要结局包括生物学、行为和心理指标以及过程指标。测量将在基线和 3 个月和 9 个月时进行。在 3 个月时测试干预组和对照组之间的结局变化；在 3 个月和 9 个月时在两个族裔群体内部和之间测试随时间的效果。
预计 DiAlert 干预措施在 3 个月时比对照组更能有效实现显著的体重减轻，无论是荷兰人还是荷兰土耳其裔参与者。
荷兰国家试验注册处（NTR）：NTR2036。
