NCT01216306

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

2.7 years

First QC Date

September 15, 2010

Last Update Submit

December 4, 2013

Conditions

Keywords

ObesityPhysical ActivitySedentary ActivityTelevision viewingLatinoHispanicPreschoolSchoolHead Start

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Adiposity and obesity at follow up

    The follow up measurement of television viewing will occur 8-10 weeks after the start of the study

  • Physical activity at follow up

    The follow up measurement of television viewing will occur 8-10 weeks after the start of the study

Study Arms (2)

Television reduction curriculum

EXPERIMENTAL

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.

Behavioral: Television reduction curriculum

Control

NO INTERVENTION

Students will be taught the standard preschool curriculum.

Interventions

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.

Also known as: Fit 5 Kids
Television reduction curriculum

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Clinically underweight, undernutrition, or failure to thrive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Ogren M, Baranowski T, Lowry SJ, Mendoza JA. Model of goal directed behavior for limiting Latino preschoolers' television viewing: validity and reliability. BMC Public Health. 2020 Feb 5;20(1):185. doi: 10.1186/s12889-020-8268-x.

  • Mendoza JA, Baranowski T, Jaramillo S, Fesinmeyer MD, Haaland W, Thompson D, Nicklas TA. Fit 5 Kids TV Reduction Program for Latino Preschoolers: A Cluster Randomized Controlled Trial. Am J Prev Med. 2016 May;50(5):584-592. doi: 10.1016/j.amepre.2015.09.017. Epub 2015 Nov 10.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jason A Mendoza, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

September 15, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations