Clinical trial NCT00503074: Starting Healthy Staying Healthy Pilot Trial
Official title: Starting Healthy Staying Healthy Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Diet, reducing
Television
Child Behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2007-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 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

Primary outcomes:
measure: Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks)
timeFrame: at conclusion of trial and 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Child Health Institute, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Frederick J Zimmerman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.