Open Access Study protocol

DiAlert: a lifestyle education programme aimed at people with a positive family history of type 2 diabetes and overweight, study protocol of a randomised controlled trial

Wieke H Heideman1*, Vera Nierkens3, Karien Stronks3, Barend JC Middelkoop2, Jos WR Twisk4, Arnoud P Verhoeff5, Maartje de Wit1 and Frank J Snoek1

Author Affiliations

1 Department of Medical Psychology, The EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands

2 Department of Public health and Primary Care, Leiden University Medical Centre, Leiden, The Netherlands

3 Department of Public Health, Academic Medical Centre, University of Amsterdam, The Netherlands

4 Department of Clinical Epidemiology and Biostatistics, The EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands

5 Department of Epidemiology, Documentation and Health Promotion, Amsterdam Municipal Health Service, Amsterdam, the Netherlands + Department of Sociology and Anthropology, University of Amsterdam, The Netherlands

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BMC Public Health 2011, 11:751  doi:10.1186/1471-2458-11-751

Published: 30 September 2011

Abstract

Background

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.

Discussion

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.

Trial registration

Netherlands National Trial Register (NTR): NTR2036