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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943628
Recruitment Status Completed
First Posted May 9, 2019
Last update posted December 11, 2019
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.
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.
|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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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
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
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).
(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.
United States, Florida
University of Miami
University of Miami
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigator: Guillermo Prado, PhD University of Miami