title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands National Trial Register (NTR): NTR2036.
authors.affiliation: Department of Medical Psychology, The EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. w.heideman@vumc.nl
authors.forename: Wieke H
authors.initials: WH
authors.lastname: Heideman
authors.forename: Vera
authors.initials: V
authors.lastname: Nierkens
authors.forename: Karien
authors.initials: K
authors.lastname: Stronks
authors.forename: Barend J C
authors.initials: BJ
authors.lastname: Middelkoop
authors.forename: Jos W R
authors.initials: JW
authors.lastname: Twisk
authors.forename: Arnoud P
authors.initials: AP
authors.lastname: Verhoeff
authors.forename: Maartje
authors.initials: M
authors.lastname: de Wit
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Snoek
mesh_terms: D000328:Adult; D000368:Aged; D054521:Cultural Competency; D003924:Diabetes Mellitus, Type 2 / Q000208:ethnology / Q000235:genetics / Q000517:prevention & control*; D054242:Emigrants and Immigrants; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017063:Outcome Assessment, Health Care / Q000379:methods; D050177:Overweight / Q000208:ethnology / Q000235:genetics / Q000517:prevention & control*; D011322:Primary Prevention / Q000193:education*; D040242:Risk Reduction Behavior; D014421:Turkey / Q000208:ethnology