|- candidate number||0|
|- NTR Number||NTR43|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||1-jul-2005|
|- Secondary IDs||N/A |
|- Public Title||Amsterdam Lifestyle Intervention on Food and Exercise at Work.|
|- Scientific Title||A randomized controlled trial on the preventive effects of a physical activity enhancing and healthy eating program on weight control among an overweight working population.|
|- hypothesis||It is hypothesized that participation in a healthy lifestyle program, aimed at controlling body weight by increasing physical activity and improving eating habits, may contribute to the reduction of overweight, to weight maintenance and consequently to the prevention of health problems, like type 2 diabetes mellitus, hypertension, hypercholesterolaemia and cardiovascular diseases.|
|- Healt Condition(s) or Problem(s) studied||Overweight|
|- Inclusion criteria||1. Paid employment on a permanent basis;|
2. BMI ³ 25 kg/m2;
3. Adequate knowledge of the Dutch language;
4. Access to the internet and knowledge of how to use it;
5. At least 18 years of age.
|- Exclusion criteria||Employees will be excluded for the following reasons: pregnancy, diagnosis or treatment of cancer, or any other disorder that makes physical activity impossible.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2002|
|- planned closingdate||1-aug-2006|
|- Target number of participants||1386|
|- Interventions||Two intervention conditions (phone-based [N=462] or Internet-based intervention[N=464]) or a reference group (N=460);|
In addition, employees were randomized to either a group of employees having basic measures only (80% out of each group) or to a group of employees having additional measures (i.e. waist circumference, body fat percentage, blood pressure, total cholesterol level and fitness level; 20% subjects of each group). The two-step randomization means there are six groups an employee could be assigned to.
|- Primary outcome||1. Change in body weight;|
2. Change in physical activity level;
3. Change in dietary intake.
|- Secondary outcome||Health, empowerment, self-efficacy and stage-of-change in relation to weight control, physical activity and eating habits, and sickness absence.|
|- Trial web site||http://www.alifeatwork.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Caroline Dekkers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Caroline Dekkers|
|- Sponsor/Initiator ||VU University Medical Center, EMGO-Institute, Body@Work TNO-VUmc, Research Center Physical Activity, Work and Health|
(Source(s) of Monetary or Material Support)
|the Netherlands Organisation for Health Research and Development, Body@Work TNO VU Medical Center, Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Publications||1. BMC Public Health. 2006 May 24;6:140. |
2. BMC Med Res Methodol. 2008 Oct 28;8(1):69. [Epub ahead of print].
|- Brief summary||Block randomization was used.|
In this randomized controlled trial, 1386 overweight employees are participating and being followed for two years. Participants are employees working at seven different companies throughout The Netherlands.
Subjects in the phone-based group received the healthy lifestyle intervention program in a binder and were counseled by phone; subjects in the internet-based group followed the same program on the Internet and were counseled by e-mail.
Subjects in the reference group received information brochures with general information on overweight, physical activity and healthy nutrition, and were not counseled. The intervention program lasted six months and took place in the first half year of the two years.
Measurements are taken at baseline, and at 6, 12, 18 and 24 months of follow-up.
|- Main changes (audit trail)|
|- RECORD||14-jul-2005 - 2-dec-2008|