Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/07/2009
Date assigned
02/09/2009
Last edited
12/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.balanceatwork.org

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

Other

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

01/06/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.vumc.nl/english/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20003405
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22383591
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23288297
4. 2013 economic evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/23969508

Publication citations

  1. Results

    Verweij LM, Proper KI, Weel AN, Hulshof CT, van Mechelen W, Design of the Balance@Work project: systematic development, evaluation and implementation of an occupational health guideline aimed at the prevention of weight gain among employees., BMC Public Health, 2009, 9, 461, doi: 10.1186/1471-2458-9-461.

  2. Results

    Verweij LM, Proper KI, Weel AN, Hulshof CT, van Mechelen W, The application of an occupational health guideline reduces sedentary behaviour and increases fruit intake at work: results from an RCT., Occup Environ Med, 2012, 69, 7, 500-507, doi: 10.1136/oemed-2011-100377.

  3. Results

    Verweij LM, Proper KI, Weel AN, Hulshof CT, van Mechelen W, Long-term effects of an occupational health guideline on employees' body weight-related outcomes, cardiovascular disease risk factors, and quality of life: results from a randomized controlled trial., Scand J Work Environ Health, 2013, 39, 3, 284-294, doi: 10.5271/sjweh.3341.

  4. Economic evaluation

    van Wier MF, Verweij LM, Proper KI, Hulshof CT, van Tulder MW, van Mechelen W, Economic evaluation of an occupational health care guideline for prevention of weight gain among employees., J. Occup. Environ. Med., 2013, 55, 9, 1100-1109, doi: 10.1097/JOM.0b013e31829b279a.

Additional files

Editorial Notes