Expired Study
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Houston, Texas 77030


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

1 K07 CA131178


NCT ID:

NCT01216306


Secondary ID:


Study Acronym:


Brief Title:

Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children


Official Title:

Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

3 Years


Maximum Age:

5 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Seattle Children's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

252


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jason A Mendoza, MD, MPH
Principal Investigator
Seattle Children's Hospital

Study Dates

Start Date:October 2010
Completion Date:August 2013
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 4, 2013
First Received Date:September 15, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Television viewing at follow up
Time Frame:The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Safety Issues:False
Description:Television viewing (hours) will be measured by television viewing diaries completed by the parents for up to 7-days
Outcome Type:Secondary Outcome
Measure:Adiposity and obesity at follow up
Time Frame:The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Safety Issues:False
Description:Body mass index calculated from measured height and weight obtained per standard protocol. Waist circumference measured per standard protocol.
Outcome Type:Secondary Outcome
Measure:Physical activity at follow up
Time Frame:The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Safety Issues:False
Description:Physical activity (duration and intensity) objectively measured by accelerometers for up to 7-days.

Study Interventions

Intervention Type:Behavioral
Name:Television reduction curriculum
Description: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.
Arm Name:Television reduction curriculum
Other Name:Fit 5 Kids

Study Arms

Study Arm Type:Experimental
Arm Name:Television reduction curriculum
Description:Students are taught the television reduction curriculum during the school day and parents are invited to attend after-school meetings to discuss reducing their children's television viewing.
Study Arm Type:No Intervention
Arm Name:Control
Description:Students will be taught the standard preschool curriculum.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Seattle Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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