The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
316
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
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
Wageningen University
Wageningen, Netherlands
Change in fasting insulin
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Glucose tolerance
fasting glucose, 2h glucose, 2h insulin, HbA1c
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
body weight, BMI, waist and hip circumference, body fat
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
measured with six-minute walk test
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
Measured as nutrient intake and food intake, with a Food Frequency Questionnaire
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Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Physical activity behaviour
Measured with questionnaire
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Behavioural determinants
Determinants of nutrition and physical activity behaviour, measured with questionnaire
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Process indicators
Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods
Time frame: Baseline, end of intervention (12 months), after follow-up (18 months)