Reducing Obesity Health Disparities in Hispanic Youth

Not Applicable

Completed

• Conditions: Sexual Behavior; Drug Use; Overweight; Family Relations; Adolescent Behavior
• Interventions: Behavioral: Familias Unidas

• Registration Number: NCT03943628
• Lead Sponsor: University of Miami

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-12
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Familias Unidas	Familias Unidas	Consists of eight parent group sessions and four family sessions with the adolescent.
Community Practice	Familias Unidas	Consists of community practice.

Primary Outcome Measures

Name	Time	Method
Physical Activity Questionnaire	Baseline and 6-, 12-, 24- months post-baseline	Change in moderate to vigorous physical activity over time
NHANES Dietary Screener Questionnaire (DSQ)	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.

Secondary Outcome Measures

Name	Time	Method
BMI	Baseline and 6-, 12-, 24- months post-baseline	Collection of raw BMI data for children and adults
Parent-Adolescent Communication Scale	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
Drug Use (items from Monitoring the Future Survey)	Baseline and 6-, 12-, 24- months post-baseline	Measure to assess frequency of adolescent drug use
Adolescent Sexual Risk Behaviors	Baseline and 6-, 12-, 24- months post-baseline	Measure to assess adolescent sexual activity
Parenting Practices Questionnaire	Baseline and 6-, 12-, 24- months post-baseline	Measure to assess parental investment

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States