Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children

Obesity Clinical Trial

Official title:

Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216306
• Other study ID #: 1K07CA131178
• Status: Completed
• Phase: N/A
• First received: September 15, 2010
• Last updated: December 4, 2013
• Start date: October 2010
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Obesity has been linked to the development of multiple cancers, and to poorer prognoses and higher mortality rates for certain pediatric and adult cancers. Preventing obesity is therefore a major strategy to prevent new cases of cancer and to decrease cancer related morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood obesity strongly tracks into adulthood this epidemic among children greatly increases the risk of obesity and presumably cancer in adulthood. As a result, preventing childhood obesity has been selected as a major public health goal to reduce the risk and sequelae of obesity and cancer in the US.

Moreover, television (TV) viewing has been identified as a major risk factor for childhood obesity and US children spent more time watching TV than any other activity except sleep. TV viewing contributes to excess weight gain by decreasing physical activity and increasing caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for parents to limit their children's total entertainment media time to no more than 1 to 2 hours of quality programming per day for children greater than 2 years of age. Low-income and minority children were at greater risk for exceeding this recommendation.

Few published interventions have been successful in decreasing TV viewing in children and only one was successful among preschool children. This intervention, "Fit 5 Kids" (i.e. fit by age 5 years), was a preschool curriculum designed to decrease TV viewing via age-appropriate lessons taught to the children by research staff. The curriculum also included a take-home component consisting of a newsletter with ideas for parent (for this grant, defined as the adult most responsible for the child's care, usually the mother) and child activities that complemented the school lesson plans. Although most behavioral interventions for preschoolers target parents rather than children, this curriculum was one of the few successful interventions targeted directly at children. However, Fit 5 Kids was not designed for or evaluated among Hispanic preschool children, the subpopulation of preschool children most severely affected by obesity. Moreover, no published intervention has successfully reduced both TV viewing and excess weight gain in any preschool population. In order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5 Kids TV reduction curriculum among Hispanic preschool children enrolled in the Head Start Program.

Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV watching and encourage alternative activities such as family meals and active playtime. The primary goal of this research plan will be to conduct a pilot group randomized controlled trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess weight gain in low income, Hispanic preschool children

To achieve the project goals, the investigators Specific Aim includes:

1. To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start centers each year for 3 years and conduct a group randomized controlled study of the adapted Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight gain in Hispanic preschool children.

The Primary Hypothesis to be tested includes:

H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight gain among Hispanic preschool children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• 3-5 year old Hispanic children enrolled at the specific Head Start centers who have agreed to collaborate on this study

Exclusion Criteria:

• Clinically underweight, undernutrition, or failure to thrive

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Physical Activity
• Sedentary Activity
• Television Viewing

Intervention

Behavioral:
• Television reduction curriculum
Students are taught the television reduction curriculum during the school day (15-30 minutes/day) 3-5 days/week over 7 weeks. Parents are invited to attend brief after-school meetings every other week to discuss reducing their children's television viewing.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Television viewing at follow up	Television viewing (hours) will be measured by television viewing diaries completed by the parents for up to 7-days	The follow up measurement of television viewing will occur 8-10 weeks after the start of the study	No
Secondary	Adiposity and obesity at follow up	Body mass index calculated from measured height and weight obtained per standard protocol. Waist circumference measured per standard protocol.	The follow up measurement of television viewing will occur 8-10 weeks after the start of the study	No
Secondary	Physical activity at follow up	Physical activity (duration and intensity) objectively measured by accelerometers for up to 7-days.	The follow up measurement of television viewing will occur 8-10 weeks after the start of the study	No