Contact information
Type
Scientific
Contact name
Dr Caroline Dekkers
ORCID ID
Contact details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 1707
c.dekkers@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR43
Study information
Scientific title
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
Acronym
ALIFE@Work
Study hypothesis
It is hypothesised 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 two diabetes mellitus, hypertension, hypercholesterolaemia and cardiovascular diseases.
Ethics approval(s)
The study design, procedures and informed consent form were approved by the Medical Ethics Committee of the VU University Medical Center (ref: 03/193), and all participants provided written informed consent.
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Overweight
Intervention
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.
Intervention type
Other
Primary outcome measure
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.
Secondary outcome measures
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.
Overall study start date
01/08/2002
Overall study end date
01/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1386
Participant 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
Recruitment start date
01/08/2002
Recruitment end date
01/08/2006
Locations
Countries of recruitment
Netherlands
Study participating centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
EMGO-Institute
Department of Public and Occupational Health
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands) - EMGO-Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Heart Foundation (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/05/2006 | Yes | No | |
| Results article | results | 24/01/2011 | Yes | No | |
| Other publications | economis evaluation | 11/09/2012 | Yes | No |