NCT03943628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

May 7, 2019

Last Update Submit

May 7, 2022

Conditions

OverweightFamily RelationsAdolescent BehaviorDrug UseSexual Behavior

Keywords

preventionHispanic adolescentsobesity and overweightnessfamily functioningsexual risk behavior

Outcome Measures

Primary Outcomes (2)

  • Physical Activity Questionnaire

    Change in moderate to vigorous physical activity over time

    Baseline and 6-, 12-, 24- months post-baseline

  • NHANES Dietary Screener Questionnaire (DSQ)

    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 Outcomes (5)

  • BMI

    Baseline and 6-, 12-, 24- months post-baseline

  • Parenting Practices Questionnaire

    Baseline and 6-, 12-, 24- months post-baseline

  • Parent-Adolescent Communication Scale

    Baseline and 6-, 12-, 24- months post-baseline

  • Drug Use (items from Monitoring the Future Survey)

    Baseline and 6-, 12-, 24- months post-baseline

  • Adolescent Sexual Risk Behaviors

    Baseline and 6-, 12-, 24- months post-baseline

Study Arms (2)

Familias Unidas

EXPERIMENTAL

Consists of eight parent group sessions and four family sessions with the adolescent.

Behavioral: Familias Unidas

Community Practice

OTHER

Consists of community practice.

Behavioral: Familias Unidas

Interventions

Familias UnidasBEHAVIORAL
Community PracticeFamilias Unidas

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • Adolescent attending 7th or 8th grade at the time of the initial assessment (T1).
  • Adolescent living with an adult primary caregiver who is willing to participate in the study.
  • 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.
  • 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).

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • Perrino T, Brincks AM, Estrada Y, Messiah SE, Prado G. Reducing Screen-Based Sedentary Behavior Among Overweight and Obese Hispanic Adolescents Through a Family-Based Intervention. J Phys Act Health. 2022 Jul 7;19(7):509-517. doi: 10.1123/jpah.2022-0050. Print 2022 Jul 1.

    PMID: 35894971DERIVED

  • Kobayashi MA, Lee TK, St George SM, Lebron C, Dorcius D, Prado G, Messiah SE. Intergenerational cardiovascular disease risks among Hispanics living in the United States. Pediatr Obes. 2022 Apr;17(4):e12870. doi: 10.1111/ijpo.12870. Epub 2021 Nov 8.

    PMID: 34751514DERIVED

  • Fernandez A, Lozano A, Lee TK, Estrada Y, Messiah SE, Prado G. A Family-Based Healthy Lifestyle Intervention: Crossover Effects on Substance Use and Sexual Risk Behaviors. Prev Sci. 2021 Jul;22(5):602-608. doi: 10.1007/s11121-021-01220-z. Epub 2021 Mar 10.

    PMID: 33689118DERIVED

  • Prado G, Fernandez A, St George SM, Lee TK, Lebron C, Tapia MI, Velazquez MR, Messiah SE. Results of a Family-Based Intervention Promoting Healthy Weight Strategies in Overweight Hispanic Adolescents and Parents: An RCT. Am J Prev Med. 2020 Nov;59(5):658-668. doi: 10.1016/j.amepre.2020.06.010. Epub 2020 Oct 1.

    PMID: 33011010DERIVED

MeSH Terms

Conditions

OverweightAdolescent BehaviorSexual BehaviorObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Guillermo Prado, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

January 12, 2015

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)