(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention

Diabetes Mellitus Type 2 Clinical Trial

— SLIMMER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02094911
• Other study ID #: NL37994.081.11
• Status: Active, not recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 19, 2014
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: March 2014
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 316
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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:
• 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

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Dutch Diabetes Research Foundation, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting insulin		Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Glucose tolerance	fasting glucose, 2h glucose, 2h insulin, HbA1c	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Serum lipids	total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Body fatness	body weight, BMI, waist and hip circumference, body fat	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Physical fitness	measured with six-minute walk test	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Blood pressure		Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Medication use		Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Quality of Life		Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Eating behaviour	Measured as nutrient intake and food intake, with a Food Frequency Questionnaire	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Physical activity behaviour	Measured with questionnaire	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Behavioural determinants	Determinants of nutrition and physical activity behaviour, measured with questionnaire	Baseline, end of intervention (12 months), after follow-up (18 months)	No
Secondary	Process indicators	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)	No