Starting Healthy Staying Healthy Pilot Trial

NCT ID: NCT00503074

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet.

Detailed Description

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TV viewing is among the most significant features of childhood. In the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of TV, one-third under 6 have TVs in their bedrooms, and 30% make TV part of bedtime routines. By the age of 2 years, 90% of children watch TV or videos regularly. Among those who watch, average viewing is 1.5 hours daily by age 2.

Yet the effects of this early viewing are poorly understood. In this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods.

We will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). A case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. In addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. The website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. The control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. At the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch TV compared to control-arm infants.

The comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.

Conditions

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Obesity

Keywords

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Diet, reducing Television Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Parents receive tailored health-behavior change messages designed to reduce their child's exposure to televised food commercials. Intervention is delivered by a case manager, by a website, and by periodic newsletters.

Group Type EXPERIMENTAL

TV modification

Intervention Type BEHAVIORAL

Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.

Control

Parents of children ages 2-5 receive behavioral-change counseling around toddler \& preschooler safety and injury prevention.

Group Type ACTIVE_COMPARATOR

safety and injury prevention

Intervention Type BEHAVIORAL

Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.

Interventions

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TV modification

Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.

Intervention Type BEHAVIORAL

safety and injury prevention

Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must watch at least 1.5 hours of television a day on average
* Must speak English at home
* Residence in or near Seattle

Exclusion Criteria

* Developmental delay
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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Frederick J Zimmerman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Child Health Institute, University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Zimmerman FJ, Ortiz SE, Christakis DA, Elkun D. The value of social-cognitive theory to reducing preschool TV viewing: a pilot randomized trial. Prev Med. 2012 Mar-Apr;54(3-4):212-8. doi: 10.1016/j.ypmed.2012.02.004. Epub 2012 Feb 14.

Reference Type DERIVED
PMID: 22349644 (View on PubMed)

Other Identifiers

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07-6609-J01

Identifier Type: -

Identifier Source: org_study_id