- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959309
Media Use in Preschooler Study (MUPS)
Media Use in Preschooler Study (MUPS) An Office Based Intervention to Improve Media Use in Preschool Children: a Randomized Controlled Trial
Childhood obesity is an epidemic and increasing. There are very few effective treatments for obesity in children. Recent studies have shown an association between obesity and sedentary behaviors such as television, video viewing and playing video games ('screen time') in preschool aged children. A school based intervention to reduce screen time in older children has been effective in preventing obesity.
The reduction of screen time may lead to the prevention of obesity and its complications in preschool children.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There have been no trials examining an intervention to decrease screen time in preschool children in the physician office setting. This setting is appealing for interventions directed to preschool children because of accessibility. In addition, other public health interventions implemented in a physician office setting, such as home safety advice, have been effective.
The proposed study design will be a randomized controlled trial. The intervention group will receive the study intervention, which is a 15 minute session about the health impact of screen time in children and strategies to decrease screen time.
The objective of this study is to determine if an office based intervention is effective in decreasing screen time (television, video viewing and playing video games) in preschool children.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- registered to attend a 3 year old well child visit
Exclusion Criteria:
- children with limitations in ambulation or cognitive delay will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
15 minute session about the health impact of screen time in children and strategies to decrease screen time (removing televisions from the child's bedroom, budgeting screen time, providing a contingency plan for time spent not watching TV, encouraging family meal time, and implementing a one week television turn off, where children are encouraged to spend one week without watching TV/videos). Activities for the child include reading a story about television viewing (The Berenstain Bears and Too Much TV), and creating a list of non TV related activities to replace TV time. The intervention group will receive a CPS handout titled 'Promoting Good Television Habits' and a calendar with stickers for the television turn off. Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home') |
|
Active Comparator: Control
|
Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parent reported number of hours screen time on the previous weekday and previous weekend day
Time Frame: 6 and 12 months
|
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of meals in front of the TV
Time Frame: 6 and 12 months
|
6 and 12 months
|
|
Activity levels
Time Frame: 6 and 12 months
|
6 and 12 months
|
|
Anthropometric measures
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine Birken, MD, The Hospital for Sick Children, Toronto Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000009542
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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