Amsterdam Lifestyle Intervention on Food and Exercise at Work

ISRCTN	ISRCTN04265725
DOI	https://doi.org/10.1186/ISRCTN04265725
Protocol serial number	NTR43
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funders	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)

Submission date: 04/08/2005
Registration date: 04/08/2005
Last edited: 08/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Caroline Dekkers
Scientific

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 1707
Email	c.dekkers@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	ALIFE@Work
Study objectives	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.
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1386
Key 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
Key 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
Date of first enrolment	01/08/2002
Date of final enrolment	01/08/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Van der Boechorststraat 7

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes