|- candidate number||6697|
|- NTR Number||NTR2095|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2009|
|- Secondary IDs||2008-055 WC EMGO+ Instituut|
|- Public Title||The effectiveness of a tailor-made intervention to prevent and reduce overweight and musculoskeletal complaints among construction workers.|
|- Scientific Title||The effectiveness of a tailor-made intervention to prevent and reduce overweight and musculoskeletal complaints among construction workers.|
|- ACRONYM||VIP in de bouw|
|- hypothesis||It is hypothesised that body weight will decrease and body composition will improve as a result of the intervention resulting from improved lifestyle and energy balance (increase in physical activity and/or lower calorie intake). Musculoskeletal complaints are expected to decrease as a result of improved physical capacity due to training and reduced body weight. In addition, an increase in physical activity will have positive effects on physical fitness, CVD risk factors, and (as a result of the positive effects mentioned above) work related measures are expected to improve.|
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity, Muscoskeletal disorders, Muscoskeletal complaints|
|- Inclusion criteria||1. Being employed at the company at least for 12 months following inclusion; |
2. Not being absent from work long-term;
3. Having signed an informed consent.
|- Exclusion criteria||Workers being on long term sick leave (4 or more weeks).|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||560|
|- 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 obesity and musculoskeletal complaints;
2. Respondents will receive a tailored intervention by means of specific programme materials and counselling;
3. The control group will receive care as usual.
|- Primary outcome||1. Body weight;|
2. Waist circumference:
3. Musculoskeletal complaints.
|- Secondary outcome||1. Physical activity;|
2. Dietary intake;
3. Sedentary behaviour;
4. Cardiorespiratory fitness;
5. Cardiovascular disease risk profile;
6. Sick leave;
|- Timepoints||At baseline, 6, and 12 months measurements take place.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. L. Viester|
|- CONTACT for SCIENTIFIC QUERIES||Dr. K.I. Proper |
|- Sponsor/Initiator ||VU University Medical Center, EMGO Institute|
(Source(s) of Monetary or Material Support)
|Delta Lloyd Groep|
|- Brief summary||The prevalence of obesity continues to increase rapidly. It is common knowledge that obesity has a negative impact on health, short term (for example musculoskeletal disorders) as well as long term (for example diabetes and cardiovascular disease). Recent research data show that the prevalence of overweight and obesity in workers in the construction industry is even higher than in the general Dutch adult population. Furthermore, in construction workers the prevalence of musculoskeletal disorders (MSD) is high. These complaints result in sickness absence and productivity loss and are possibly related to an unhealthy lifestyle.
This research project will consist of two phases. In the first phase, the intervention will be developed using an intervention mapping protocol. To increase the effectiveness and chances of successful implementation of the intervention, and the workers’ compliance, the development will take place in close cooperation with the target group and management of the organisation. The second phase of this project aims at evaluating the intervention. The additional effect of the developed lifestyle intervention compared to usual care will be investigated by means of a randomised controlled trial (RCT). Participants will be assigned randomly to two different groups: (1) a control group receiving usual care, (2) an intervention group receiving the intervention designed for this research in addition to usual care.
Measurements will take place preceding the intervention (baseline, T0), directly following the intervention (after 6 months, T1), and after 12 months (T2) to evaluate the long term effects.
Primary outcome variables are body weight and musculoskeletal complaints. Secondary outcome variables will be physical fitness, lifestyle behaviours and work-related variables such as vitality, productivity, and work ability. In addition, the cost-effectiveness of the intervention will be analysed. Finally, a process evaluation will be performed.
|- Main changes (audit trail)|
|- RECORD||5-nov-2009 - 18-nov-2009|