|- candidate number||2569|
|- NTR Number||NTR966|
|- Date ISRCTN created||30-mei-2007|
|- date ISRCTN requested||22-mei-2007|
|- Date Registered NTR||2-mei-2007|
|- Secondary IDs||ZonMw project number 62300039 |
|- Public Title||Individual health promotion on physical activity and nutrition among workers|
|- Scientific Title||Cost-effectiveness of an individually-tailored long-term worksite health promotion program on physical activity and nutrition: a cluster randomised controlled trial.|
|- hypothesis||It is hypothesized that long-term electronic communication through the web and e-mails (the Health Portal) provides efficient means to increase exposure to advice on healthy behavior and to facilitate adherence and sustainability.|
|- Healt Condition(s) or Problem(s) studied||Nutrition, Physical activity, Worksite, Health promotion|
|- Inclusion criteria||Eligibility criteria for individual workers are:
1. Paid employment;
2. Working at least 12 hours a week;
3. Being literate enough to read and understand simple e-mail and internet-based messages in the Dutch language.|
|- Exclusion criteria||Exclusion criteria for individual workers are:
1. Insufficient Dutch language skills.
2. Working less than 12 hours a week.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-mrt-2007|
|- planned closingdate||28-feb-2011|
|- Target number of participants||1400|
|- Interventions||1. usual care control group:
Standard worksite health promotion program consisting of a questionnaire, a health check with a biometric assessment and access to a restricted part of the Health Portal on Internet containing personal results on the questionnaire and health check and general information on health.
2. intervention group:
on top of the standard worksite health promotion program the intervention group will have access to the personalized Health Portal on Internet which is built on 4 critical features:
- computer-tailored advice on physical activity and nutrition
- reports on individual progress in self-reported weight, body mass index, physical activity and fruit and vegetables consumption.
- opportunity to contact professionals through e-mail
- continuous support and feedback through e-mail by a personal coach
After 12 months the monthly contact by a personal coach will be terminated, but access to the Health Portal will remain another 12 months.
Data will be collected by means of a questionnaire at baseline, and after 12 and 24 months and a health check at baseline and after 24 months.
|- Primary outcome||1. Change in (moderate and vigorous) physical activity level using the International Physical Activity Questionnaire;
2. Change in level of fruit and vegetable intake using the short Dutch Food Frequency Questionnaire.
|- Secondary outcome||1. Self-efficacy and perceived barriers on physical activity and fruit and vegetable consumption;
2. Change in self-reported saturated fat intake
3. By using the SCORE system a risk profile on cardiovascular disease, consisting of systolic blood pressure, gender, smoking and total cholesterol level will be assessed;
4. Body mass index, waist circumference and body fat percentage;
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. S.J.W. Robroek |
|- CONTACT for SCIENTIFIC QUERIES|| A. Burdorf |
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Public Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||BACKGROUND Cardiovascular disease (CVD) is a leading cause of disability and mortality in the Netherlands. Major modifiable risk factors for CVD include low physical activity and poor nutrition. The prevalence of these risk factors has increased in the past decades. In the prevention of CVD programs that promote adoption and maintenance of a healthy lifestyle are of great importance. Worksites have specific features, including an efficient structure to reach large groups and make use of a natural social network for peer support, that make the worksite a promising place for health promotion. In this study a worksite health promotion program (WHPP), consisting of a personal Health Portal on Internet, on different cardiovascular risk factors will be evaluated.
OBJECTIVES The main objectives of this study are 1) to evaluate the effectiveness of a WHPP, consisting of a personal Health Portal, on adherence to lifestyle recommendations and sustainability of a healthy lifestyle, and 2) to evaluate the cost-effectiveness of the personal Health Portal on top of a standard WHPP.
METHODS/DESIGN The study is a pragmatic cluster randomised controlled trial with the worksite as the unit of randomisation. The study population consists of workers in companies that offer a standard WHPP to their employees. All workers receive a standard WHPP, consisting of a questionnaire, a health check with a biometric assessment and a report with personal results. The intervention group additionally has access to a personal Health Portal on Internet with as main features 1) computer tailored advice on physical activity, fruit and vegetable consumption and fat intake, 2) a monitor function in which one can report individual progress in self-reported weight, body mass index, physical activity and fruit and vegetable intake over time, 3) the possibility to consult professionals, such as a personal coach, a physiotherapist, or a dietician through e-mail, and 4) continuous feedback and support through monthly e-mails by a personal coach. Primary outcome indicators will be compliance with national recommendations for physical activity and fruit and vegetable intake, measured with self-administered questionnaires.
|- Main changes (audit trail)|
|- RECORD||2-mei-2007 - 8-aug-2007|