(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined lifestyle intervention

Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period

Group Type EXPERIMENTAL

Combined lifestyle intervention

Intervention Type BEHAVIORAL

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

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.

Group Type OTHER

Usual care group

Intervention Type OTHER

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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Other Intervention Names

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SLIMMER intervention

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No