Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 2
Treatments combined lifestyle intervention, usual care group
Sponsor Wageningen University
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date October 2011
End date May 2014
Trial size 316 participants
Trial identifier NCT02094911, NL37994.081.11

Summary

The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
combined lifestyle intervention SLIMMER intervention
10-month intervention period with: weekly group-based sports lessons supervised by a physiotherapist individual dietary advice by a dietician case management by practice nurse maintenance programme to guide subjects to maintain lifestyle behaviour change
(Other)
Subjects receive brochures on healthy lifestyle at baseline, and during the 10-month intervention period only usual care as provided by their own general practitioner.
usual care group
Written information on healthy lifestyle was provided at baseline, no individual advice or programme was provided. No additional appointments were scheduled, apart from the visits for follow-up measurements

Primary Outcomes

Measure
Change in fasting insulin
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)

Secondary Outcomes

Measure
Glucose tolerance
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Blood pressure
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Medication use
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Quality of Life
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Eating behaviour
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical activity behaviour
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Behavioural determinants
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Process indicators
time frame: Baseline, end of intervention (12 months), after follow-up (18 months)

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

Inclusion Criteria: - Age 40-70 years - Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and ≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test - Willing and able to participate in the intervention for at least 1.5 years - Dutch speaking Exclusion Criteria: - Known diabetes mellitus - Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible - Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement - Medication known to interfere with glucose tolerance - Any mental or physical disability that will hinder participation in the lifestyle intervention - Severe psychiatric disease - Patients who showed bad compliance in the past - Participation in another regular vigorous exercise and/or diet programme, i.e.: - Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative. - Intensive diet programme: patients who visited a dietician at least 3 times during the last year.

Additional Information

Official title Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
Principal investigator Edith Feskens, PhD
Description This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Wageningen University.