Starting Healthy Staying Healthy Pilot Trial

This study has been completed.
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00503074
First received: July 16, 2007
Last updated: November 18, 2009
Last verified: November 2009

July 16, 2007
November 18, 2009
July 2007
February 2008   (final data collection date for primary outcome measure)
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks) [ Time Frame: at conclusion of trial and 6 months post-intervention ] [ Designated as safety issue: No ]
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks) [ Time Frame: at conclusion of trial and 6 months post-intervention ]
Complete list of historical versions of study NCT00503074 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Starting Healthy Staying Healthy Pilot Trial
Starting Healthy Staying Healthy Pilot Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • Behavioral: 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.
  • Behavioral: safety and injury prevention
    Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.
  • Experimental: 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.
    Intervention: Behavioral: TV modification
  • Active Comparator: Control
    Parents of children ages 2-5 receive behavioral-change counseling around toddler & preschooler safety and injury prevention.
    Intervention: Behavioral: safety and injury prevention
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. Epub 2012 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503074
07-6609-J01
Yes
Frederick J. Zimmerman, Associate Professor, University of Washington
University of Washington
Seattle Children's Hospital
Principal Investigator: Frederick J Zimmerman, Ph.D. University of Washington
University of Washington
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP