Reducing Obesity Health Disparities in Hispanic Youth

May 7, 2022 updated by: Guillermo Prado, University of Miami

Families Preventing and Reducing Obesity Health Disparities in Hispanic Youth

The proposed study will evaluate the efficacy of a family-based obesity prevention intervention in increasing physical activity and improving the quality of dietary intake among Hispanic Youth. Additional primary outcomes that will be examined include drug use and sexual risk behaviors. Secondary outcomes include examining the effects of family functioning and BMI. The knowledge expected to be gained in this study will have strong implications for prevention as well as contribute to the reduction of obesity-related health disparities seen in Hispanic youth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study's aims are: AIM 1: To examine the relative efficacy of Familias Unidas, extended to target obesity, in increasing physical activity and improving the quality of dietary intake among overweight Hispanic youth and AIM 2: To examine whether and to what extent family functioning partially mediates the effects of Familias Unidas on physical activity and quality of dietary intake.

H1: Familias Unidas will be efficacious, compared to Community Practice, in increasing Hispanic youth's past moderate to vigorous physical activity over time.

H2: Familias Unidas will be efficacious, compared to Community Practice, in improving Hispanic youth's past quality dietary intake (defined as decreases in dietary intakes of sugar-sweetened beverages, fast foods, and increases in dietary intakes of fresh fruits and vegetables) over time.

H3: Familias Unidas' effects on youth's past day moderate to vigorous physical activity and youth's past quality dietary intake will be partially mediated by changes in family functioning over time.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  1. Female and male adolescents of Hispanic immigrant origin, defined by at least one parent (or legal guardian/primary caregiver) born in a Spanish speaking country of the Americas.
  2. Adolescent attending 7th or 8th grade at the time of the initial assessment (T1).
  3. Adolescent living with an adult primary caregiver who is willing to participate in the study.
  4. At T1, families must live within the catchment areas of the middle schools included in this study: Citrus Grove, Shenandoah Middle, Kinloch Park, Ponce de Leon, Rivera, South Miami, Glades, and Carver Middle Schools. All eight schools are located within a single school district, and have a population that is predominantly Hispanic (70% or greater across all three schools). Our staff has conducted studies with these schools for over 15 years (see letter of support from the Miami-Dade County Public School District), which collectively serve over 2,000 Hispanic 8th graders per year. We will be recruiting over three academic school years. Thus, we do not anticipate any barriers to recruiting the target sample size from the 6,000 Hispanic 8th graders (of which approximately 1800 are expected to be overweight) enrolled in these schools over the three academic years.
  5. Adolescents must meet criterion for overweight (i.e. body mass index [BMI] > 85% adjusted for age and sex). We decided to select overweight youth for a number of reasons: (1) In our prior research with Familias Unidas, we have found that our intervention is most successful for more at- risk samples and less efficacious for universal samples (IOM, 2009) and (2) The needs of normal- weight (or underweight) youth may not be adequately or appropriately addressed by a family-based intervention targeting behavioral risk factors for obesity. For example, Whitlock and colleagues found that including normal-weight youth in research studies may induce individual and parental preoccupation with weight, weight management, and dietary and physical activity behaviors and, thus, have iatrogenic effects (Whitlock et al., 2005).

EXCLUSION CRITERIA:

(a) Family planning to move out of the catchment areas of the target schools during the 3 month intervention period, or out of the South Florida area during the two year follow-up phase of the study. (b) Parent or youth refuses to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Familias Unidas
Consists of eight parent group sessions and four family sessions with the adolescent.
Behavioral: Familias Unidas
Other: Community Practice
Consists of community practice.
Behavioral: Familias Unidas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Questionnaire
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Change in moderate to vigorous physical activity over time
Baseline and 6-, 12-, 24- months post-baseline
NHANES Dietary Screener Questionnaire (DSQ)
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Change in quality dietary intake (decreases in dietary intakes of sugar-sweetened beverages, fast foods, and increases in dietary intakes of fresh fruits and vegetables) over time.
Baseline and 6-, 12-, 24- months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Collection of raw BMI data for children and adults
Baseline and 6-, 12-, 24- months post-baseline
Parenting Practices Questionnaire
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess parental investment
Baseline and 6-, 12-, 24- months post-baseline
Parent-Adolescent Communication Scale
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess quality and content of communication. Items are measured on a scale from 1= Strongly disagree, 2=Moderately disagree, 3=Neither agree nor disagree, 4=Moderately agree and 5=Strongly agree. Higher values represent a better outcome. Sum scores are used to determine a total score
Baseline and 6-, 12-, 24- months post-baseline
Drug Use (items from Monitoring the Future Survey)
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess frequency of adolescent drug use
Baseline and 6-, 12-, 24- months post-baseline
Adolescent Sexual Risk Behaviors
Time Frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess adolescent sexual activity
Baseline and 6-, 12-, 24- months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2015

Primary Completion (Actual)

December 27, 2018

Study Completion (Actual)

December 27, 2018

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130195
  • R01MD007724 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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