|- candidate number||3012|
|- NTR Number||NTR1190|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jan-2008|
|- Secondary IDs||WC2007-062 |
|- Public Title||Work in Balance - The (cost) effectiveness of a guideline to improve physical activity and dietary behavior in order to prevent weight gain.|
|- Scientific Title||Work in Balance - The (cost) effectiveness of a guideline to improve physical activity and dietary behavior in order to prevent weight gain.|
|- ACRONYM||Work in Balance|
|- hypothesis||The intervention group, receiving a lifestyle intervention, will significantly improve physical activity and dietary behavior, and thus prevent weight gain compared to the control group at the short (6 months) and the longer term (12 months). |
|- Healt Condition(s) or Problem(s) studied||Obesity|
|- Inclusion criteria||1. Being insufficiently active or having overweight;|
2. 18-55 years old;
3. Not being on sick leave for the last 7 days;
4. Ability to complete Dutch questionnaire;
5. Having signed informed consent.
|- Exclusion criteria||Disease or pregnancy which makes physical activity impossible.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2008|
|- planned closingdate||31-dec-2011|
|- Target number of participants||800|
|- Interventions||Detailed information about the format and content of the intervention cannot be given yet, as it will be developed during the first phase of the project. Based on current literature and experience, the intervention may include the following components: |
1. The intervention will be aimed at physical activity and dietary behavior (both sides of the energy balance) in order to prevent weight gain;
2. Using social ecological models and implementation intentions, respondents will receive a tailored intervention by means of counselling/ face-to-face/ telephone/internet contacts;
3. The control group will receive care as usual.
|- Primary outcome||Physical activity, dietary behaviour, waist circumference and body weight.|
|- Secondary outcome||General health status, quality of life, cardiovascular disease, risk profile, sick leave and cost-effectiveness.|
|- Timepoints||At baseline, 6, 12, and 18 months measurements take place.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc L Verweij|
|- CONTACT for SCIENTIFIC QUERIES||Dr. K.I. Proper |
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The prevalence of overweight and obesity is high among the Dutch population and is associated with an enormous public health impact as well as with an economic burden. As it is expected that the prevalence of overweight will increase further, there is an urgent need to intervene in order to prevent weight gain. Based on an extensive systematic literature research (BRAVO reviews), the workplace is identified as an appropriate setting for effective and feasible primary prevention lifestyle promotion. The Netherlands Society of Occupational Medicine (NVAB) recognises this and shows the need for information on how to counsel as to physical activity and dietary behavior, and which strategy is effective. |
The aims of this study are thus:
1. to develop a weight gain prevention guideline to be used by occupational health (OH) professionals, which is focused on improving workers' physical activity and dietary behaviour;
2. to evaluate the (cost-) effectiveness of this guideline;
3. to implement this guideline in the OH services in the Netherlands.
Following the standard template of the NVAB in formulating OHS guidelines and using the Intervention Mapping protocol, a blue print version of the guideline will be developed, and afterwards evaluated. The guideline will provide clear-cut recommendations to the OP on how to improve workers’ physical activity and dietary behavior. Researchers, occupational practitioners (OP) and other relevant stakeholders will be consulted in the developmental phase. The guideline will be evaluated using a RCT design with 2 arms, randomized at the OP level (n=10). During the Periodical Medical Screening OPs of the intervention group will be asked to apply the guideline (including the tailored lifestyle intervention) to eligible workers. The OPs in the control group will perform their usual care. Eligible workers (2x n=220) will be measured at baseline, 6, 12 and 18 months.
Primary outcome measures are physical activity, dietary behaviour, waist circumference and body weight.
Secondary outcome measures are general health status, quality of life, cardiovascular disease, risk profile and sick leave. Moreover, cost-effectiveness and cost-utility will be determined.
Based on the results, the guideline will be adapted and implemented in the OHS. The project started in January 2008.
|- Main changes (audit trail)|
|- RECORD||16-jan-2008 - 28-apr-2008|