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

Tracking Information
First Received Date ^ICMJE	June 14, 2010
Last Updated Date	December 12, 2011
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 1, 2010)	Body Mass Index (BMI)-for-age percentile [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01156402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 1, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Childhood Obesity Prevention Program for Hispanics
Official Title ^ICMJE	Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Childhood Obesity
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Active Intervention: Obesity Prevention Intervention: Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health Experimental: Alternative Intervention/control: Oral Health Intervention: Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	650
Estimated Completion Date	November 2014
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	5 Years to 8 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01156402
Other Study ID Numbers ^ICMJE	030425PC062 03 (Meharry IRB)
Has Data Monitoring Committee	No
Responsible Party	Meharry Medical College
Study Sponsor ^ICMJE	Meharry Medical College
Collaborators ^ICMJE	Vanderbilt University
Investigators ^ICMJE	Not Provided
Information Provided By	Meharry Medical College
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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