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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00065052
Other study ID # MODHTV (completed)
Secondary ID 1R01DK063442
Status Completed
Phase N/A
First received July 16, 2003
Last updated January 12, 2010
Start date September 2002
Est. completion date May 2007

Study information

Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if limiting television (TV) and computer time will result in a stabilization or smaller increase in body mass index (BMI), lower energy intake, and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over two years.


Description:

There is a positive correlation between obesity and television watching in adults and children. And, television watching, controlling for current obesity, is a predictor of future obesity. Almost half of all children watch 3 or more hours of television each day. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours each day.

Families will be randomized to one of two conditions. Half the families will be taught to use the TV Allowance to reduce their child's TV and computer use by one-half over a six month period and the other half will use the device to monitor TV watching (control group). This study uses TV Allowance units to monitor home television watching, video game playing, and computer use. The TV Allowance can also be used to limit the amount of TV and computer use by programming it to allow a specific number of hours for each family member. Heights, weights, food intake, and physical activity will be measured at baseline and every six months. The purpose of this study is to determine if limiting television and computer time will result in a stabilization or smaller increase in BMI, lower energy intake, and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over two years.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 7 Years
Eligibility - Greater than the 85th BMI percentile

- Minimum of 15 hours of TV watching, computer use, and video game playing per week

- No medical conditions that may affect the child's ability to safely participate in physical activity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior modification


Locations

Country Name City State
United States University at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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