Plain English Summary
Not provided at time of registration
Study website
Contact information
Type
Scientific
Contact name
Ms Lisanne Verweij
ORCID ID
Contact details
Vrije University Medical Center
EMGO+ Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 9681
l.verweij@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
NTR1190
Study information
Scientific title
The (cost)-effectiveness of an occupational health guideline to improve physical activity and dietary behaviour among workers in order to prevent weight gain: a randomised, controlled, parallel group, single blinded trial
Acronym
Balance@Work
Study hypothesis
The intervention group, receiving a lifestyle intervention, is expected to significantly improve their daily physical activity and dietary behaviour, and thus prevent weight gain compared to the control group at the short (6 months) and the longer term (12 months).
Ethics approval(s)
Ethics Committee of the VU University Medical Centre ('Medisch Ethische Toetseingscommissie VU medisch centrum') approved on the 7th May 2009 (ref: 2009/002).
Study design
Randomised controlled parallel group single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity prevention
Intervention
The intervention is aimed at physical activity and dietary behaviour (both sides of the energy balance) in order to prevent weight gain. Using social ecological models and implementation intentions, respondents receive a tailored intervention by means of counselling based on motivational interviewing by occpational physicians. The control group receives care as usual.
Treatment in the intervention group is 6 months. Follow-up measurements in both groups take place at 6, 12, and 18 months after baseline.
Intervention type
Other
Primary outcome measure
1. Physical activity, measured with the Squash questionnaire at baseline, 6, 12, and 18 months
2. Dietary behaviour, measured with the Short Fruit and Vegetable questionnaire and the Fat list at baseline, 6, 12, and 18 months
3. Waist circumference, measured with the Seca 201 waist circumference measure at baseline, 6, 12, and 18 months
4. Body weight at baseline, 6, 12, and 18 months
Secondary outcome measures
1. General health status (sedentary behaviour measured with the International Physical Activity Questionnaire [IPAQ], anthropometrics [body weight, body height, blood pressure and cholesterol] measured retrospectively) at baseline, 6, 12, and 18 months
2. Quality of life, measured with the EQ-5D questionnaire at baseline, 6, 12, and 18 months
3. Cardiovascular disease risk profile, calculated following SCORE at baseline, 6, 12, and 18 months
4. Sick leave, measured with the HPQ questionnaire at 3, 6, 9, 12, 15, and 18 months
5. Cost-effectiveness, measured with EQ-5D and HPQ data at 3, 6, 9, 12, 15, and 18 months
Overall study start date
01/06/2009
Overall study end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Workers who do not comply to Dutch physical activity and nutrition guidelines, and/or workers who are overweight
2. Aged 18 - 55 years, either sex
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
600
Participant exclusion criteria
1. Unable to be physically active
2. Not sufficiently capable of using the Dutch language
3. Not having signed an informed consent form
4. Sick leave for the last 3 weeks
Recruitment start date
01/06/2009
Recruitment end date
01/06/2011
Locations
Countries of recruitment
Netherlands
Study participating centre
Vrije University Medical Center
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
EMGO+ Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 9681
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 120510007)
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
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/12/2009 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No | |
| Other publications | economic evaluation | 01/09/2013 | Yes | No |