Condition category
Not Applicable
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
01/09/2009
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 Gitte Kloek

ORCID ID

Contact details

Erasmus Medical Center
Department of Public Health
P.O. BOX 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4087422
g.kloek@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR616; 4010.0033

Study information

Scientific title

Acronym

Study hypothesis

The computer-tailored health information in combination with personal counselling leads to:
1. Improvement of health behaviors
2. Improvement of parental satisfaction with well-child care visits
3. Improvement of well-child care provider satisfaction with well-child care visits

Ethics approval

Received from local medical ethics committee

Study design

Multicentre radomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Unintentional injuries, overweight

Intervention

Parents are randomised into one of two groups below:
1. Tailored health information in combination with personal counselling
2. Usual care
Depending on the age of the child, the topics of the tailored health education program will differ. Parents of babies (n = 240) will receive health information on safety behaviors. Parents of toddlers (n = 240) will receive health information on overweight related health behaviors: physical activity and nutrition. Parents in the intervention group will access the computer-tailored health education program at their homes through the internet. After completion of the assessment questions, the program compiles a tailored health information handout. During the next well-child visit the well-child care provider will discuss this tailored health information with the parent.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Parents' child safety behaviors relevant to prevention of burns, drowning, falls, and poisoning; intentions to adopt child safety behaviors; beliefs about preventive behaviors
2. Children's physical activity and child nutrition and feeding practices; awareness of physical activity behavior and feeding practices

Secondary outcome measures

Well-child care provider: satisfaction with well-child visit
Parents: satisfaction with well-child visits

Overall trial start date

01/04/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Parents visiting the youth health care centre for well-child visits.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

480

Participant exclusion criteria

Those parents who are not able to read and understand Dutch sufficiently.

Recruitment start date

01/04/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (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) (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