Dialert, effects of a lifestyle intervention in Dutch and Turkish 1st degree relatives of persons with type 2 diabetes, a randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26716

Enrollment

268

Registered

2009-09-29

Start date

2010-01-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus type 2, life style, prevention, intervention, overweight

Interventions

The intervention comprises 2 interactive group sessions, supplemented with a patient manual. To sustain achieved behaviour changes the follow-up program includes a booster session and 4 newsletters.

Eligibility

Inclusion criteria

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: Exclusion criteria are: 1. Diagnosed with type 1 or 2 diabetes; 2. Currently under medical treatment for ischemic heart disease; 2. Cancer; 3. Renal failure; 4. Diagnosed with a psychiatric disorder; 5. Pregnancy or physically/mentally too impaired to participate in the study (e.g. unable to come to the location of the assessments and interventions); 6. Not able to write of read in Dutch or Turkish.

Design outcomes

Primary

Measure	Time frame
The main endpoint is to achieve significant reduce of body weight at 3 months following the intervention.	—

Secondary

Measure	Time frame
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? Do baseline patient characteristics predict weight loss at 6 and 9 months follow-up, within and across both ethnic groups.	—

Measure

Time frame

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? Do baseline patient characteristics predict weight loss at 6 and 9 months follow-up, within and across both ethnic groups.

—

Contacts

Public ContactW.H. Heideman

Van der Boechorststraat 7-G-417

w.heideman@vumc.nl+31 (0)20 4445682

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)