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OverweightNCT03943628

Reducing Obesity Health Disparities in Hispanic Youth

A study testing Familias Unidas in people with Overweight and Family Relations, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 15 years
Conditions the study is for
Overweight, Family Relations, Adolescent Behavior
What is being tested?
Familias Unidas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
12 Jan 2015to 27 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Familias Unidas
Keywords
prevention, Hispanic adolescents, obesity and overweightness, family functioning, sexual risk behavior
Medical subject headings
Overweight, Adolescent Behavior, Sexual Behavior, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Familias UnidasBehavioural

Study groups in NCT03943628
Study groupRoleWhat they receive
Familias UnidasExperimentalConsists of eight parent group sessions and four family sessions with the adolescent.
Receives: Behavioral: Familias Unidas
Community PracticeOtherConsists of community practice.
Receives: Behavioral: Familias Unidas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity Questionnaire

    Change in moderate to vigorous physical activity over time

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

  2. 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.

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

Secondary outcomes (5)

  1. BMI

    Collection of raw BMI data for children and adults

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

  2. Parenting Practices Questionnaire

    Measure to assess parental investment

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

  3. Parent-Adolescent Communication Scale

    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

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

  4. Drug Use (items from Monitoring the Future Survey)

    Measure to assess frequency of adolescent drug use

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

  5. Adolescent Sexual Risk Behaviors

    Measure to assess adolescent sexual activity

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start12 Jan 2015
  3. Primary completion27 Dec 2018
  4. Study completion27 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943628
Sponsor's protocol ID
20130195
Other IDs
R01MD007724
Status last verified
May 2022
First submitted
7 May 2019
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35894971

  • 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.

    PubMed 34751514

  • 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.

    PubMed 33689118

  • 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.

    PubMed 33011010

Questions about this trial

What is this clinical trial studying?

A study testing Familias Unidas in people with Overweight and Family Relations, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity Questionnaire (time frame: Baseline and 6-, 12-, 24- months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943628, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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