NCT00959309

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Oct 2007

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

August 12, 2009

Last Update Submit

November 8, 2017

Conditions

Keywords

pediatricsmediaMUPS

Outcome Measures

Primary Outcomes (1)

  • Parent reported number of hours screen time on the previous weekday and previous weekend day

    6 and 12 months

Secondary Outcomes (3)

  • Number of meals in front of the TV

    6 and 12 months

  • Activity levels

    6 and 12 months

  • Anthropometric measures

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Strategies to decrease screen time in children

Control

ACTIVE COMPARATOR
Behavioral: Non-Strategical Media Education

Interventions

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')

Intervention

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')

Control

Eligibility Criteria

Age3 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • registered to attend a 3 year old well child visit

You may not qualify if:

  • children with limitations in ambulation or cognitive delay will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Birken, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Paediatrician

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 14, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations