Diabetes Mellitus Type 2
Conditions
Keywords
Prevention, Combined lifestyle intervention, Primary health care
Brief summary
The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.
Detailed description
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
Interventions
BEHAVIORALCombined lifestyle 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
OTHERUsual 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
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Diabetes Research Foundation
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting insulin | Baseline, end of intervention (12 months), after follow-up (18 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipids | Baseline, end of intervention (12 months), after follow-up (18 months) | total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides |
| Body fatness | Baseline, end of intervention (12 months), after follow-up (18 months) | body weight, BMI, waist and hip circumference, body fat |
| Physical fitness | Baseline, end of intervention (12 months), after follow-up (18 months) | measured with six-minute walk test |
| Blood pressure | Baseline, end of intervention (12 months), after follow-up (18 months) | — |
| Medication use | Baseline, end of intervention (12 months), after follow-up (18 months) | — |
| Glucose tolerance | Baseline, end of intervention (12 months), after follow-up (18 months) | fasting glucose, 2h glucose, 2h insulin, HbA1c |
| Eating behaviour | Baseline, end of intervention (12 months), after follow-up (18 months) | Measured as nutrient intake and food intake, with a Food Frequency Questionnaire |
| Physical activity behaviour | Baseline, end of intervention (12 months), after follow-up (18 months) | Measured with questionnaire |
| Behavioural determinants | Baseline, end of intervention (12 months), after follow-up (18 months) | Determinants of nutrition and physical activity behaviour, measured with questionnaire |
| Process indicators | Baseline, end of intervention (12 months), after follow-up (18 months) | Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods |
| Quality of Life | Baseline, end of intervention (12 months), after follow-up (18 months) | — |
Countries
Netherlands
Outcome results
None listed