Dialert, effects of a lifestyle intervention in Dutch and Turkish 1st degree relatives of persons with type 2 diabetes, a randomised controlled trial.
- Conditions
- Diabetes Mellitus type 2, life style, prevention, intervention, overweight
- Registration Number
- NL-OMON26716
- Lead Sponsor
- EMGO Institute, VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 268
Inclusion Criteria
Eligible are first-degree relatives of type 2 diabetes patients (father, mother, brother or sister, son or daughter), between 25 and 65 years of age, and overweight (Body Mass Index of ≥ 25 or waist circumference > 88 cm for females and > 102 cm for males). In the Turkish group, both first and second generation Turkish immigrants are eligible.
Exclusion Criteria
Exclusion criteria are:
1. Diagnosed with type 1 or 2 diabetes;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint is to achieve significant reduce of body weight at 3 months following the intervention.
- Secondary Outcome Measures
Name Time Method Is there a significant difference in metabolic outcomes (weight, BMI, weight circumference, lipids, blood pressure, insulin resistance and HbA1c) psychological and behavioural outcomes (perceived risk and seriousness of diabetes, self-efficacy beliefs (diet, exercise, smoking), outcome expectancies, distress, motivation to change and self-reported health behaviours (diet, exercise, smoking, alcohol)) and psychological distress (anxiety an depression) from baseline to 3 months between intervention and controls and at 6 and 9 months following the intervention between and within both ethnic groups?<br /><br>Do baseline patient characteristics predict weight loss at 6 and 9 months follow-up, within and across both ethnic groups.