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Childhood Obesity Prevention Program for Hispanics

This study is currently recruiting participants.
Verified December 2011 by Meharry Medical College
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Meharry Medical College
ClinicalTrials.gov Identifier:
NCT01156402
First received: June 14, 2010
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.


Condition Intervention
Childhood Obesity
 Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meharry Medical College:

Primary Outcome Measures:
  • Body Mass Index (BMI)-for-age percentile [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child eating behaviors [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Child physical activity (accelerometers) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Parenting strategies [ Time Frame: One year ] [ Designated as safety issue: No ]
  • parent physical activity [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: May 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Intervention: Obesity Prevention Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health
The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.
Experimental: Alternative Intervention/control: Oral Health Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health
The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.

Detailed Description:

Childhood obesity has been ranked as a critical public health threat in the U.S. due to the increasing prevalence of obesity among children over the past three decades. Childhood obesity poses both intermediate and long-term health risks, as well as considerable economic costs. While this epidemic affects all socioeconomic levels, certain racial/ethnic groups are disproportionately affected, including Hispanics.The long-term goal of the current research is to contribute to the reduction of racial/ethnic disparities in obesity and obesity-related outcomes among Hispanics by testing a childhood obesity prevention program that has been culturally tailored for the Hispanic population through a participatory process. This developmental community-based participatory research (CBPR) project is a collaborative community-academic partnership between Meharry Medical College (MMC), Tennessee State University-Center for Health Research (TSU-CHR), and a grassroots community-based organization called Progreso Community Center (PCC). The Childhood Obesity Study is designed to evaluate two programs for Hispanic children ages 5 to 7 and their parents. One program focuses on nutrition and physical activity (based on NIH's "We Can!" program), and a parallel program focuses on oral health (developed by TSU's Dental Hygiene Program). Upon enrollment in the Study, parents and children will respond to an initial interview involving body measurement and questionnaire. Families will be given physical activity monitor to be worn for 7 days and randomly assigned to one of two groups. The families assigned to the Nutrition and Physical Activity Program will attend eight (8) bi-weekly classes (one every two weeks for four months) dealing with nutrition and physical activity. In the Oral Health Program families will attend 4 monthly classes (once a month for four months). These sessions deal with ways to take care of children's teeth and oral health. In addition, these families will have the opportunity to sign up for a free dental cleaning and assessment at the Dental Hygiene Clinic at Tennessee State University.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Children:

  • 5-7 year-old female or male of Hispanic origin (identified by parent)
  • resident of Davidson County or adjacent counties
  • ≥25th percentile of age- and sex-specific BMI (CDC growth charts) or one parent/caregiver with BMI ≥ 25 kg/m2
  • More than one child may enroll per family

Parents:

  • Hispanic origin (self-identified)
  • Spanish speaker
  • adult age 18 or older
  • parent of at least one eligible child
  • Only one parent per family may enroll as a study participant and respond to questionnaires

Exclusion Criteria:

Children:

  • BMI ≥ 35 kg/m2
  • Medical conditions affecting growth
  • Conditions limiting participation in the interventions or measurements
  • Taking medications affecting growth
  • No consent or inability to understand informed consent
  • Incomplete or missed baseline assessments
  • Plan to move from geographic area within the next 12 months.

Parents:

  • No exclusions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156402

Locations
United States, Tennessee
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Roger J Zoorob, MD, MPH     615-327-6572     rzoorob@mmc.edu    
Contact: Pamela Hull, PhD     615-936-3241     pam.hull@vanderbilt.edu    
Sub-Investigator: Pamela Hull, PhD            
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Pamela Hull, PhD     615-936-3241     pam.hull@vanderbilt.edu    
Sponsors and Collaborators
Meharry Medical College
Vanderbilt University
  More Information

No publications provided

Responsible Party: Meharry Medical College
ClinicalTrials.gov Identifier: NCT01156402     History of Changes
Other Study ID Numbers: 030425PC062 03 (Meharry IRB)
Study First Received: June 14, 2010
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Meharry Medical College:
Obesity
Pediatric Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013