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 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 measure
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 (if study stopped)
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
PO Box 93245
The Hague
2509 AE
Netherlands
Sponsor type
Research organisation
Website
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25880376
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27538423