Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/12/2010
Date assigned
10/02/2011
Last edited
11/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hans H.C.M. Savelberg

ORCID ID

Contact details

Maastricht University
Dept of Human Movement Science
P.O. Box 616
Maastricht
6200 MD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

50-51100-98-001

Study information

Scientific title

Cost-effectiveness of package 3 (a supervised physical training and nutrition program) versus package 2 of the BeweegKuur a combined lifestyle intervention in the prevention and treatment of overweight

Acronym

Study hypothesis

The more structured and more intense supervised intervention offered in package 3 is more effective and cost-effective in assisting people with overweight and obesity to adopt a healthier lifestyle than package 2 of the BeweegKuur.

Ethics approval

Medical Ethics Committee of Maastricht University Medical Centre, 09/07/2010, ref: 31990.068.10

Study design

Single-blind multicentre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overweight and obesity

Intervention

Experimental program is package 3 of the BeweegKuur consisting of a physical activity and dietary program. Control program is package 2 of the BeweegKuur consisting of a physical activity and dietary program.

The physical activity program takes place in the standard, local activity facilities or (temporarily) with support of a physical therapist. The characteristics of the physical activity program depend on the BeweegKuur package followed. Package 2 and 3 differ in the amount of supervision/support provided by the physical therapist. In package 2 participants receive three sessions in which barriers for being physically active are identified and participants are supported to cope with these barriers in a plan to become physical active autonomously. The physical therapist will stimulate self-initiated activities and/or visiting local movement facilities. The physical activity program of package 3 starts with intensive support from the physical therapist. Participants will exercise under supervision of the physical therapist for 12 weeks. Goal is outflow to local facilities or independent activities following these 12 weeks, if this goal is not reached, the supervision period can be extended once with 4 weeks.

The dietary program consists of (a combination of) individual tailored advice of a nutritionist and group meetings at the nutritionist with other participants. The dietary advice is based on several Dutch guidelines (dietary guidelines diabetes [NDF, 2006], guidelines good diet [Health Council, 2006], guidlines obesity diagnosis and treatment in adults and children [CBO, 2008]). The content of the dietary advice is independent from the physical activity program.

The duration of the BeweegKuur intervention is one year for both packages. Independent of the package, the participants have five meetings with their Life Style Advisor (LSA).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Moderate to vigorous physical activity (MVPA) in minutes per week. This is measured by means of:
1. Activity monitor at baseline, and at one year and two years after the start of the intervention
2. Self administered questionnaire International Physical Activity Questionnaire (IPAQ) at baseline, six months, twelve months, 18 months and 24 months

Secondary outcome measures

1. Dietary habits (short version of the ENVET) at baseline, six months, twelve months, 18 months and 24 months
2. Quality of life (EQ6-D), medication, side effects, direct and indirect costs, at baseline and every three months from baseline until 2 years of follow-up
3. Health risk, e.g. waist circumference (cm), body composition (body mass in kg, fat and fat free mass in %), diastolic blood pressure (DPB) (mmHg), systolic blood pressure (SBP) (mmHg), resting heart rate, blood values, i.e. fasting glucose (mmol/L), HbA1c (% or mmol/L), total cholesterol (mmol/L), HDL (mmol/L), triglycerides (mmol/L) and creatinin (micromol/L) and physical fitness (Astrand test, Valk neuropathy test, Timed Up and Go Test) at baseline, at one year and two years after start of the program

Overall trial start date

01/08/2010

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults with a weight-related health risk
2. Have an inactive lifestyle (Dutch norm Healthy Exercise: 30 minutes moderate physical activity for at least 5 days per week)
3. Motivated for behavioral change
4. Willing to participate after having read the informed consent information
5. Body mass index (BMI) between 25 - 30 kg/m2 combined with a large waist circumference (men greater than 102 cm, women greater than 88 cm) with comorbidity (cardiovascular disease and/or diabetes mellitus II, arthrosis and sleep apnoea)
6. BMI between 30 - 35 kg/m2 combined with a normal or large waist circumference with comorbidity
7. BMI between 35 - 40 kg/m2 combined with a normal or large waist circumference with risk factors for cardiovascular disease or diabetes mellitus II and without other comorbidity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. BMI less than 25 kg/m2
2. BMI of 25 - 30 kg/m2 combined with normal waist circumference
3. BMI of 35 - 40 kg/m2 combined with comorbidity (cardiovascular disease and/or diabetes mellitus II, arthrosis and sleep apnoea)
4. BMI of greater than 40 kg/m2
5. Impairments that prevent from participating in the BeweegKuur (according to the GP)

Recruitment start date

01/08/2010

Recruitment end date

31/07/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands

Sponsor type

Research organisation

Website

http://www.zonmw.nl/

Funders

Funder type

Research organisation

Funder name

ZonMw (ref: 50-51100-98-001)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25880376

Publication citations

Additional files

Editorial Notes

11/02/2016: Publication reference added.