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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Reducing Obesity Health Disparities in Hispanic Youth

Clinicaltrials.gov identifier NCT03943628

Recruitment Status Completed

First Posted May 9, 2019

Last update posted December 11, 2019

Study Description

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.

  • Condition or Disease:Overweight
    Family Relations
    Adolescent Behavior
    Drug Use
    Sexual Behavior
  • Intervention/Treatment: Behavioral: Familias Unidas
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 280 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Families Preventing and Reducing Obesity Health Disparities in Hispanic Youth
  • Actual Study Start Date: January 2015
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: December 2018
Arms and interventions
Arm Intervention/treatment
Other: Community Practice
Consists of community practice.
Behavioral: Familias Unidas
Experimental: Familias Unidas
Consists of eight parent group sessions and four family sessions with the adolescent.
Behavioral: Familias Unidas
Outcome Measures
  • Primary Outcome Measures: 1. Physical Activity Questionnaire [ Time Frame: Baseline and 6-, 12-, 24- months post-baseline ]
    Change in moderate to vigorous physical activity over time
  • 2. 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.
  • Secondary Outcome Measures: 1. BMI [ Time Frame: Baseline and 6-, 12-, 24- months post-baseline ]
    Collection of raw BMI data for children and adults
  • 2. Parenting Practices Questionnaire [ Time Frame: Baseline and 6-, 12-, 24- months post-baseline ]
    Measure to assess parental investment
  • 3. 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
  • 4. 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
  • 5. Adolescent Sexual Risk Behaviors [ Time Frame: Baseline and 6-, 12-, 24- months post-baseline ]
    Measure to assess adolescent sexual activity
Eligibility Criteria
  • Ages Eligible for Study: 12 to 15 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, Florida
University of Miami
Miami

Sponsors and Collaborators

University of Miami

National Institutes of Health (NIH)

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Guillermo Prado, PhD University of Miami

More Information
  • Responsible Party: University of Miami
  • ClinicalTrials.gov Identifier: NCT03943628 History of Changes
  • Other Study ID Numbers: 20130195, R01MD007724
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: December 11, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Miami: Hispanic adolescents
    prevention
    obesity and overweightness
    family functioning
    sexual risk behavior
  • Additional relevant MeSH terms: Obesity Overweight