(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention
SLIMMER
Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
1 other identifier
interventional
316
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2011
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 24, 2014
March 1, 2014
2.6 years
March 19, 2014
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fasting insulin
Baseline, end of intervention (12 months), after follow-up (18 months)
Secondary Outcomes (11)
Glucose tolerance
Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
Baseline, end of intervention (12 months), after follow-up (18 months)
Blood pressure
Baseline, end of intervention (12 months), after follow-up (18 months)
- +6 more secondary outcomes
Study Arms (2)
Combined lifestyle intervention
EXPERIMENTALLifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
Usual care group
OTHERSubjects receive brochures on healthy lifestyle at baseline, and during the 10-month intervention period only usual care as provided by their own general practitioner.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wageningen University
Wageningen, Netherlands
Related Publications (3)
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.
PMID: 31711499DERIVEDden 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.
PMID: 28606146DERIVEDDuijzer 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.
PMID: 24928217DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith Feskens, PhD
Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 24, 2014
Study Start
October 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2015
Last Updated
March 24, 2014
Record last verified: 2014-03