Childhood Obesity Prevention Program for Hispanics

Meharry Medical College

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health

Study type: Interventional

Funder types: Other

Identifiers

NCT01156402

030425PC062 03 (Meharry IRB)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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319 participants in 2 patient groups

Active Intervention: Obesity Prevention

Experimental group

Treatment:

Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health

Alternative Intervention/control: Oral Health

Experimental group

Treatment:

Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health