Starting Healthy Staying Healthy Pilot… | Clinical Trial

Key information

Conditions

Obesity Behavior Body Weight Child Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Health Institute, University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TV modification

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.

Safety and injury prevention

Behavioral

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

Seattle Children's Hospital

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 18, 2007
Registry last updated: Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed