Obesity Clinical Trial
Official title:
Reducing Television Viewing to Prevent Childhood Obesity
Randomized controlled trial to test the efficacy of reducing television, videotape and video game use to prevent obesity, increase physical activity, improve physical fitness, and decrease dietary fat and calorie intake among third grade children in twelve ethnically-diverse elementary schools.
The United States has experienced dramatic increases in obesity among both children and
adults. Population-based primary prevention may hold the greatest promise. Unfortunately,
obesity prevention programs that have specifically attempted to reduce fat and calorie
intake and increase physical activity have been relatively ineffective at reducing body
fatness. As a result, there is a pressing need for innovative interventions to prevent
obesity.
Children spend more time watching television and videotapes and playing video games than in
any other activity except sleeping. As a result, there has been widespread speculation that
television viewing might be one of the most easily modifiable causes of obesity among
children. This hypothesis has broad appeal, but has been difficult to validate.
Epidemiological studies have consistently found weak associations between media use and
childhood obesity, and additional epidemiological studies are unlikely to help clarify these
relationships.
We propose an innovative experimental model. In the current environment, in which television
viewing is already so prevalent, the question of greatest clinical, practical and policy
importance is: Will reducing television, videotape and video game use prevent childhood
obesity? As a foundation for this proposal, we have completed two pilot studies that
demonstrate (1) it is possible to significantly reduce children's television, videotape and
video game use and (2) that a school-based intervention to reduce children's television,
videotape and video game use may result in clinically significant decreases in adiposity.
We propose a school-based randomized controlled trial involving 12 ethnically- and
socioeconomically-diverse elementary schools and approximately 900 third graders. Six
schools will be randomly assigned to receive an intervention to reduce television, videotape
and video game use and the other six schools will receive an attention-placebo control
intervention, to minimize the potential for compensatory rivalry or resentful
demoralization. Our proposed intervention model is derived directly from principles of
Bandura's social cognitive theory and includes a classroom curriculum and parent
newsletters. The primary intervention will be delivered throughout the third grade school
year.
Survey and physical assessments of all children will occur at baseline, at the end of 3rd
grade (post-test) and at the beginning and end of 4th grade (4 month and one year
follow-ups, respectively). A subsample of children will participate in 4 days of activity
monitoring and three 24-hour dietary recalls at baseline, post-test and one-year follow-up.
Parents will be interviewed by phone.
PRIMARY HYPOTHESIS: Compared to controls, third grade children exposed to a school-based
intervention to reduce time spent watching television and videotapes and playing video
games, will significantly reduce their body mass index (BMI, kg/m2). In addition, triceps
skinfold thickness and waist and hip ratio will be measured to further characterize changes
in obesity resulting from the intervention.
SECONDARY HYPOTHESES: Children attending intervention schools will significantly decrease
the amount of time they spend watching television, watching videotapes and playing video
games; Children attending intervention schools will significantly increase their levels of
moderate to vigorous physical activity and total physical activity; Children attending
intervention schools will significantly improve their physical fitness; Children attending
intervention schools will significantly reduce their fat intakes and total calorie intakes;
Children attending intervention schools will significantly reduce the number of meals and
snacks they eat while watching television and videotapes or playing video games.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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