Biomarker evaluation of different types of Internet-based interactive computer-tailored nutrition education on fat consumption

ISRCTN	ISRCTN01557410
DOI	https://doi.org/10.1186/ISRCTN01557410
Protocol serial number	NTR623
Sponsor	Erasmus University Medical Center
Funder	ZonMw

Submission date: 04/04/2006
Registration date: 04/04/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Willemieke Kroeze
Scientific

Erasmus Medical Center
Department of Public Health
Room AE 139
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 4089253
Email	w.kroeze@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised, single blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Biomarker evaluation of different types of Internet-based interactive computer-tailored nutrition education on fat consumption
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Intention to change 2. Process measures
Completion date	21/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	841
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	24/03/2003
Date of final enrolment	21/04/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3000 CA
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	29/04/2008	06/01/2021	Yes	No

Editorial Notes

06/01/2021: Publication reference added.