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
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