Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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13 January 2015 |
Main ID: |
ISRCTN04265725 |
Date of registration:
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04/08/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Amsterdam Lifestyle Intervention on Food and Exercise at Work
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Scientific title:
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A randomised controlled trial on the preventive effects of a physical activity enhancing and healthy eating program on weight control among an overweight working population |
Date of first enrolment:
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01/08/2002 |
Target sample size:
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1386 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN04265725 |
Study type:
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Interventional |
Study design:
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Randomised, active controlled, parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Caroline
Dekkers |
Address:
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Van der Boechorststraat 7
1081 BT
Amsterdam
Netherlands |
Telephone:
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+31 (0)20 444 1707 |
Email:
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c.dekkers@vumc.nl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Paid employment on a permanent basis 2. Body Mass Index (BMI) greater than or equal to 25 kg/m^2 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: 1. Pregnancy 2. Diagnosis or treatment of cancer 3. Any other disorder that makes physical activity impossible
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overweight Nutritional, Metabolic, Endocrine Obesity
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Intervention(s)
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Block randomisation was used. In this randomised controlled trial, 1386 overweight employees are participating and being followed for two years. Participants are employees working at seven different companies throughout The Netherlands.
At baseline, employees were randomised to either one of two intervention conditions (phone-based [N = 462] or Internet-based intervention [N = 464]) or a reference group (N = 460). In addition, employees were randomised 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 randomisation means there are six groups an employee could be assigned to.
Subjects in the phone-based group received the healthy lifestyle intervention program in a binder and were counselled 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 counselled. The intervention program lasted six months and took place in the first half year of the two years.
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Primary Outcome(s)
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1. Change in body weight 2. Change in physical activity level 3. Change in dietary intake
Measurements are taken at baseline, and at 6, 12, 18 and 24 months of follow-up.
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Secondary Outcome(s)
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1. Perceived health 2. Empowerment 3. Self-efficacy and stage-of-change in relation to weight control 4. Physical activity and eating habits 5. Sickness absence
Measurements are taken at baseline, and at 6, 12, 18 and 24 months of follow-up.
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Source(s) of Monetary Support
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Vrije University Medical Centre (VUMC) (The Netherlands) - EMGO-Institute, The Netherlands Heart Foundation (The Netherlands), The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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