Back to results(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention (SLIMMER)
Primary Purpose
Diabetes Mellitus Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Combined lifestyle intervention
Usual care group
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus Type 2 focused on measuring Prevention, Combined lifestyle intervention, Primary health care
Eligibility Criteria
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.
Sites / Locations
- Wageningen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Combined lifestyle intervention
Usual care group
Arm Description
Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
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.
Outcomes
Primary Outcome Measures
Change in fasting insulin
Secondary Outcome Measures
Glucose tolerance
fasting glucose, 2h glucose, 2h insulin, HbA1c
Serum lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Body fatness
body weight, BMI, waist and hip circumference, body fat
Physical fitness
measured with six-minute walk test
Blood pressure
Medication use
Quality of Life
Eating behaviour
Measured as nutrient intake and food intake, with a Food Frequency Questionnaire
Physical activity behaviour
Measured with questionnaire
Behavioural determinants
Determinants of nutrition and physical activity behaviour, measured with questionnaire
Process indicators
Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods
Full Information
NCT ID
NCT02094911
First Posted
March 19, 2014
Last Updated
March 19, 2014
Sponsor
Wageningen University
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02094911
Brief Title
(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention
Acronym
SLIMMER
Official Title
Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Diabetes Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Prevention, Combined lifestyle intervention, Primary health care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined lifestyle intervention
Arm Type
Experimental
Arm Description
Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
Arm Title
Usual care group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined lifestyle intervention
Other Intervention Name(s)
SLIMMER intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care group
Intervention Description
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 Outcome Measure Information:
Title
Change in fasting insulin
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Secondary Outcome Measure Information:
Title
Glucose tolerance
Description
fasting glucose, 2h glucose, 2h insulin, HbA1c
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Serum lipids
Description
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Body fatness
Description
body weight, BMI, waist and hip circumference, body fat
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Physical fitness
Description
measured with six-minute walk test
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Blood pressure
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Medication use
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Quality of Life
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Eating behaviour
Description
Measured as nutrient intake and food intake, with a Food Frequency Questionnaire
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Physical activity behaviour
Description
Measured with questionnaire
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Behavioural determinants
Description
Determinants of nutrition and physical activity behaviour, measured with questionnaire
Time Frame
Baseline, end of intervention (12 months), after follow-up (18 months)
Title
Process indicators
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Feskens, PhD
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University
City
Wageningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
31711499
Citation
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.
Results Reference
derived
PubMed Identifier
28606146
Citation
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.
Results Reference
derived
PubMed Identifier
24928217
Citation
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.
Results Reference
derived
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(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention
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