Childhood Obesity Prevention Program for Hispanics

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	319 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
Study Start Date :	May 2010
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	May 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Body Mass Index (BMI)-for-age percentile [ Time Frame: one year ]

Secondary Outcome Measures :

1. Child eating behaviors [ Time Frame: One year ]
2. Child physical activity (accelerometers) [ Time Frame: One year ]
3. Parenting strategies [ Time Frame: One year ]
4. parent physical activity [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 8 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Meharry Medical College
Nashville, Tennessee, United States, 37208

Sponsors and Collaborators

Meharry Medical College

Vanderbilt University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Meharry Medical College
ClinicalTrials.gov Identifier:	NCT01156402 History of Changes
Other Study ID Numbers:	030425PC062 03 (Meharry IRB)
First Posted:	July 2, 2010
Last Update Posted:	May 6, 2016
Last Verified:	May 2016

Keywords provided by Meharry Medical College:

Obesity; Pediatric Obesity

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms