Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.alifeatwork.nl

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2002

Overall trial end date

01/08/2006

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.vumc.nl/english/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16723021
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21261935
3. 2012 economis evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22967224

Publication citations

  1. Results

    van Wier MF, Ariëns GA, Dekkers JC, Hendriksen IJ, Pronk NP, Smid T, van Mechelen W, ALIFE@Work: a randomised controlled trial of a distance counselling lifestyle programme for weight control among an overweight working population [ISRCTN04265725]., BMC Public Health, 2006, 6, 140, doi: 10.1186/1471-2458-6-140.

  2. Results

    Dekkers JC, van Wier MF, Ariëns GA, Hendriksen IJ, Pronk NP, Smid T, van Mechelen W, Comparative effectiveness of lifestyle interventions on cardiovascular risk factors among a Dutch overweight working population: a randomized controlled trial., BMC Public Health, 2011, 11, 1, 49, doi: 10.1186/1471-2458-11-49.

  3. Economis evaluation

    van Wier MF, Dekkers JC, Bosmans JE, Heymans MW, Hendriksen IJ, Pronk NP, van Mechelen W, van Tulder MW, Economic evaluation of a weight control program with e-mail and telephone counseling among overweight employees: a randomized controlled trial., Int J Behav Nutr Phys Act, 2012, 9, 112, doi: 10.1186/1479-5868-9-112.

Additional files

Editorial Notes