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
  Purpose

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.


Condition Intervention
Obesity
Behavioral: TV modification
Behavioral: safety and injury prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Starting Healthy Staying Healthy Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Control
Parents of children ages 2-5 receive behavioral-change counseling around toddler & preschooler safety and injury prevention.
Behavioral: safety and injury prevention
Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503074

Locations
United States, Washington
Child Health Institute, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
Investigators
Principal Investigator: Frederick J Zimmerman, Ph.D. University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederick J. Zimmerman, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00503074     History of Changes
Other Study ID Numbers: 07-6609-J01
Study First Received: July 16, 2007
Last Updated: November 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Diet, reducing
Television
Child Behavior

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014