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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Dutch Diabetes Research Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined lifestyle intervention | Experimental | Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period |
|
| Usual care group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined lifestyle intervention | Behavioral | 10-month intervention period with:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting insulin | Baseline, end of intervention (12 months), after follow-up (18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose tolerance | fasting glucose, 2h glucose, 2h insulin, HbA1c | Baseline, end of intervention (12 months), after follow-up (18 months) |
| Serum lipids | total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides |
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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.:
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| Name | Affiliation | Role |
|---|---|---|
| Edith Feskens, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31711499 | Derived | Duijzer G, Bukman AJ, Meints-Groenveld A, Haveman-Nies A, Jansen SC, Heinrich J, Hiddink GJ, Feskens EJM, de Wit GA. Cost-effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care: economic evaluation from a randomised controlled trial. BMC Health Serv Res. 2019 Nov 11;19(1):824. doi: 10.1186/s12913-019-4529-8. | |
| 28606146 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual care group | Other | 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 |
|
| Baseline, end of intervention (12 months), after follow-up (18 months) |
| Body fatness | body weight, BMI, waist and hip circumference, body fat | Baseline, end of intervention (12 months), after follow-up (18 months) |
| Physical fitness | measured with six-minute walk test | Baseline, end of intervention (12 months), after follow-up (18 months) |
| 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) |
| Quality of Life | 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 | Baseline, end of intervention (12 months), after follow-up (18 months) |
| Physical activity behaviour | Measured with questionnaire | Baseline, end of intervention (12 months), after follow-up (18 months) |
| Behavioural determinants | Determinants of nutrition and physical activity behaviour, measured with questionnaire | 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 | Baseline, end of intervention (12 months), after follow-up (18 months) |
| den Braver NR, de Vet E, Duijzer G, Ter Beek J, Jansen SC, Hiddink GJ, Feskens EJM, Haveman-Nies A. Determinants of lifestyle behavior change to prevent type 2 diabetes in high-risk individuals. Int J Behav Nutr Phys Act. 2017 Jun 12;14(1):78. doi: 10.1186/s12966-017-0532-9. |
| 24928217 | Derived | Duijzer G, Haveman-Nies A, Jansen SC, ter Beek J, Hiddink GJ, Feskens EJ. SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation. BMC Public Health. 2014 Jun 14;14:602. doi: 10.1186/1471-2458-14-602. |
| D004700 | Endocrine System Diseases |