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Effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes

A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41209683
Enrollment
240
Registered
2013-10-30
Start date
2010-05-15
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Type 2 diabetes/impaired fasting glucose Nutritional, Metabolic, Endocrine

Interventions

Randomisation is at the level of the general practices and they are followed up at one and two years. Intervention group General practices assigned to the intervention group apply a protocol called ?

Sponsors

Julius Center for Health Sciences and Primary Care (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All subjects diagnosed with IFG and motivated to change their lifestyle

Exclusion criteria

Exclusion criteria: 1. Subjects with emotional, psychological or intellectual problems that are likely to limit the ability of the individual to comply with the protocol 2. Malignant diseases 3. Other diseases or conditions associated with a poor prognosis

Design outcomes

Primary

MeasureTime frame
Change in body mass index (BMI). Measurements were performed at baseline (T0) just after the diagnoses of IFG and before the start of the intervention, and after 1 (T1) and 2 (T2) years.

Secondary

MeasureTime frame
1. Waist circumference 2. Total and saturated fat intake 3. Physical activity 4. Systolic blood pressure 5. Blood glucose 6. Total cholesterol 7. Triglycerides 8. Behaviour determinants risk perception 9. Perceived knowledge, motivation, attitude, self efficacy and social norm Anthropometric parameters and risk factors for developing diabetes were measured by a practice nurse. Biochemical parameters are determined in regional laboratories. Information about fat intake, physical activity, motivation and behaviour determinants were measured by questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026