(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention (SLIMMER)

March 19, 2014 updated by: Wageningen University

Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER

The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).

Study Type

Interventional

Enrollment (Anticipated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • SLIMMER intervention
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fasting insulin
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Baseline, end of intervention (12 months), after follow-up (18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
fasting glucose, 2h glucose, 2h insulin, HbA1c
Baseline, end of intervention (12 months), after follow-up (18 months)
Serum lipids
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Baseline, end of intervention (12 months), after follow-up (18 months)
Body fatness
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
body weight, BMI, waist and hip circumference, body fat
Baseline, end of intervention (12 months), after follow-up (18 months)
Physical fitness
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
measured with six-minute walk test
Baseline, end of intervention (12 months), after follow-up (18 months)
Blood pressure
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Baseline, end of intervention (12 months), after follow-up (18 months)
Medication use
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Baseline, end of intervention (12 months), after follow-up (18 months)
Quality of Life
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Baseline, end of intervention (12 months), after follow-up (18 months)
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
Baseline, end of intervention (12 months), after follow-up (18 months)
Physical activity behaviour
Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)
Measured with questionnaire
Baseline, end of intervention (12 months), after follow-up (18 months)
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
Baseline, end of intervention (12 months), after follow-up (18 months)
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
Baseline, end of intervention (12 months), after follow-up (18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Diabetes Research Foundation

Investigators

  • Principal Investigator: Edith Feskens, PHd, Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL37994.081.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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