Cost-effectiveness of package 3 versus package 2 of the BeweegKuur in the prevention and treatment of overweight
| ISRCTN | ISRCTN46574304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46574304 |
| Secondary identifying numbers | 50-51100-98-001 |
- Submission date
- 23/12/2010
- Registration date
- 10/02/2011
- Last edited
- 31/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hans H.C.M. Savelberg
Scientific
Scientific
Maastricht University
Dept of Human Movement Science
PO Box 616
Maastricht
6200 MD
Netherlands
Study information
| Study design | Single-blind multicentre cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Medical Ethics Committee of Maastricht University Medical Centre, 09/07/2010, ref: 31990.068.10 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2010 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
PO Box 93245
The Hague
2509 AE
Netherlands
| Website | http://www.zonmw.nl/ |
|---|---|
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
ZonMw (ref: 50-51100-98-001)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/03/2015 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No |
Editorial Notes
31/01/2018: Publication reference added.
11/02/2016: Publication reference added.
