Balance@Work: the (cost)-effectiveness of an occupational health guideline to improve physical activity and dietary behaviour among workers in order to prevent weight gain

ISRCTN	ISRCTN73545254
DOI	https://doi.org/10.1186/ISRCTN73545254
Protocol serial number	NTR1190
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 120510007)

Submission date: 27/07/2009
Registration date: 02/09/2009
Last edited: 12/05/2014

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

Ms Lisanne Verweij
Scientific

Vrije University Medical Center
EMGO+ Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 9681
Email	l.verweij@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group single blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Balance@Work
Study objectives	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).
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	600
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Center

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes