Clinical trial NCT02094911: (Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention
Official title: Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Prevention
Combined lifestyle intervention
Primary health care
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch Diabetes Research Foundation
First posted: 2014-03-24
Enrollment: 316
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Change in fasting insulin
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
Secondary outcomes:
measure: Glucose tolerance
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Serum lipids
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Body fatness
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Physical fitness
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Blood pressure
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Medication use
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Quality of Life
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Eating behaviour
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Physical activity behaviour
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Behavioural determinants
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
measure: Process indicators
timeFrame: Baseline, end of intervention (12 months), after follow-up (18 months)
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Edith Feskens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.