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Trial record 1 of 1 for:    slimmer wageningen university
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(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention (SLIMMER)

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ClinicalTrials.gov Identifier: NCT02094911
Recruitment Status : Unknown
Verified March 2014 by Wageningen University.
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Wageningen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Behavioral: Combined lifestyle intervention Other: Usual care group Not Applicable

Detailed Description:
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
Study Start Date : October 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combined lifestyle intervention
Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
 Behavioral: Combined lifestyle intervention

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
Other Name: SLIMMER intervention
Usual care group
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.
 Other: Usual care group
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in fasting insulin [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]

Secondary Outcome Measures :
  1. Glucose tolerance [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    fasting glucose, 2h glucose, 2h insulin, HbA1c

  2. Serum lipids [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

  3. Body fatness [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    body weight, BMI, waist and hip circumference, body fat

  4. Physical fitness [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    measured with six-minute walk test

  5. Blood pressure [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
  6. Medication use [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
  7. Quality of Life [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
  8. Eating behaviour [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    Measured as nutrient intake and food intake, with a Food Frequency Questionnaire

  9. Physical activity behaviour [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    Measured with questionnaire

  10. Behavioural determinants [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    Determinants of nutrition and physical activity behaviour, measured with questionnaire

  11. Process indicators [ Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months) ]
    Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094911


Locations
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Netherlands
Wageningen University
Wageningen, Netherlands
Sponsors and Collaborators
Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Diabetes Research Foundation
Investigators
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Principal Investigator: Edith Feskens, PhD Wageningen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02094911    
Other Study ID Numbers: NL37994.081.11
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Wageningen University:
Prevention
Combined lifestyle intervention
Primary health care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases