Condition category
Not Applicable
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Willemieke Kroeze

ORCID ID

Contact details

Erasmus Medical Center
Department of Public Health
Room AE 139
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4089253
w.kroeze@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR623

Study information

Scientific title

Acronym

Study hypothesis

Computer-tailored health education has been found to be a promising intervention technique to improve a variety of health related behaviours, such as physical activity and dietary behaviours. To be able to improve efficacy, efficiency and applicability of computer-tailored interventions, more in-depth investigations are needed into the most effective delivery forms (print versus interactive), the feedback elements that contribute to efficacy, and whether intervention effects can also be demonstrated using biomarkers as an outcome measure.

The aim of the present study was three-fold:
1. To investigate whether provision of interactive computer-tailored information versus in print format differ in efficacy
2. To identify the minimally required feedback elements of a computer-tailored intervention
3. To evaluate the intervention effects using biomarkers as an outcome measure in addition to self-reported behaviour

These research questions were studied in relation to a computer-tailored intervention aimed at fat intake. Fat intake is an important behavioural risk factor and computer-tailored interventions have been found most effective in reducing fat intake. The study was conducted among healthy adults recruited from nine companies and two communities in the area of Rotterdam.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, single blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

No condition, healthy person

Intervention

The study contains four experimental conditions and one control group:
1. Computer-tailored personal feedback on fat consumption in print form
2. Computer-tailored personal and normative feedback on fat consumption in print form
3. Computer-tailored personal, normative and action feedback on fat consumption in print form
4. Computer-tailored personal, normative and action feedback on fat consumption in web-based form (CD-ROM)
5. Generic information on fat consumption in print form (control group)

All the intervention materials were provided once.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Total fat and saturated fat consumption - measured with a validated food frequency questionnaire developed by Wageningen University
2. Blood lipids (total cholesterol, high density lipoprotein [HDL], low density lipoprotein [LDL], triglycerides) - sampling and analysing conducted by a certified laboratory (Star Rotterdam)

Secondary outcome measures

1. Intention to change
2. Process measures

Overall trial start date

24/03/2003

Overall trial end date

21/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 - 65 years
2. No prescribed diet from dietician or physician
3. No treatment for hyper-cholesterolaemia
4. Sufficient understanding of the Dutch language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

841

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

24/03/2003

Recruitment end date

21/04/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Public Health
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

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

Publication citations

Additional files

Editorial Notes