Reducing Obesity Health Disparities in Hispanic Youth
Primary Purpose
Overweight, Family Relations, Adolescent Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Familias Unidas
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring prevention, Hispanic adolescents, obesity and overweightness, family functioning, sexual risk behavior
Eligibility Criteria
INCLUSION CRITERIA:
- 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).
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Familias Unidas
Community Practice
Arm Description
Consists of eight parent group sessions and four family sessions with the adolescent.
Consists of community practice.
Outcomes
Primary Outcome Measures
Physical Activity Questionnaire
Change in moderate to vigorous physical activity over time
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.
Secondary Outcome Measures
BMI
Collection of raw BMI data for children and adults
Parenting Practices Questionnaire
Measure to assess parental investment
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
Drug Use (items from Monitoring the Future Survey)
Measure to assess frequency of adolescent drug use
Adolescent Sexual Risk Behaviors
Measure to assess adolescent sexual activity
Full Information
NCT ID
NCT03943628
First Posted
May 7, 2019
Last Updated
May 7, 2022
Sponsor
University of Miami
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03943628
Brief Title
Reducing Obesity Health Disparities in Hispanic Youth
Official Title
Families Preventing and Reducing Obesity Health Disparities in Hispanic Youth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
December 27, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Family Relations, Adolescent Behavior, Drug Use, Sexual Behavior
Keywords
prevention, Hispanic adolescents, obesity and overweightness, family functioning, sexual risk behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Familias Unidas
Arm Type
Experimental
Arm Description
Consists of eight parent group sessions and four family sessions with the adolescent.
Arm Title
Community Practice
Arm Type
Other
Arm Description
Consists of community practice.
Intervention Type
Behavioral
Intervention Name(s)
Familias Unidas
Primary Outcome Measure Information:
Title
Physical Activity Questionnaire
Description
Change in moderate to vigorous physical activity over time
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Title
NHANES Dietary Screener Questionnaire (DSQ)
Description
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.
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Secondary Outcome Measure Information:
Title
BMI
Description
Collection of raw BMI data for children and adults
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Title
Parenting Practices Questionnaire
Description
Measure to assess parental investment
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Title
Parent-Adolescent Communication Scale
Description
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
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Title
Drug Use (items from Monitoring the Future Survey)
Description
Measure to assess frequency of adolescent drug use
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
Title
Adolescent Sexual Risk Behaviors
Description
Measure to assess adolescent sexual activity
Time Frame
Baseline and 6-, 12-, 24- months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35894971
Citation
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.
Results Reference
derived
PubMed Identifier
34751514
Citation
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.
Results Reference
derived
PubMed Identifier
33689118
Citation
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.
Results Reference
derived
PubMed Identifier
33011010
Citation
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.
Results Reference
derived
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Reducing Obesity Health Disparities in Hispanic Youth
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