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Childhood Obesity Prevention Program for Hispanics

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Families-Childhood Obesity Prevention and Oral Health
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Pediatric Obesity

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University
  • Meharry Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Intervention: Obesity Prevention

Alternative Intervention/control: Oral Health

Arm Description

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)-for-age percentile

Secondary Outcome Measures

Child eating behaviors
Child physical activity (accelerometers)
Parenting strategies
parent physical activity

Full Information

First Posted
June 14, 2010
Last Updated
May 5, 2016
Sponsor
Meharry Medical College
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01156402
Brief Title
Childhood Obesity Prevention Program for Hispanics
Official Title
Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meharry Medical College
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Pediatric Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Intervention: Obesity Prevention
Arm Type
Experimental
Arm Title
Alternative Intervention/control: Oral Health
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Healthy Families-Childhood Obesity Prevention and Oral Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)-for-age percentile
Time Frame
one year
Secondary Outcome Measure Information:
Title
Child eating behaviors
Time Frame
One year
Title
Child physical activity (accelerometers)
Time Frame
One year
Title
Parenting strategies
Time Frame
One year
Title
parent physical activity
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23624172
Citation
Zoorob R, Buchowski MS, Beech BM, Canedo JR, Chandrasekhar R, Akohoue S, Hull PC. Healthy families study: design of a childhood obesity prevention trial for Hispanic families. Contemp Clin Trials. 2013 Jul;35(2):108-21. doi: 10.1016/j.cct.2013.04.005. Epub 2013 Apr 26.
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Childhood Obesity Prevention Program for Hispanics

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