Reducing Obesity Health Disparities in Hispanic Youth

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT03943628

Collaborator

National Institutes of Health (NIH) (NIH), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

280

Enrollment

Location

Arms

47.5

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Overweight Family Relations Adolescent Behavior Drug Use Sexual Behavior	Behavioral: Familias Unidas	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 :

Jan 12, 2015

Actual Primary Completion Date :

Dec 27, 2018

Actual Study Completion Date :

Dec 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Familias Unidas Consists of eight parent group sessions and four family sessions with the adolescent.	Behavioral: Familias Unidas
Other: Community Practice Consists of community practice.	Behavioral: Familias Unidas

Arm

Intervention/Treatment

Experimental: Familias Unidas

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

Behavioral: Familias Unidas

Other: Community Practice

Consists of community practice.

Behavioral: Familias Unidas

Outcome Measures

Primary Outcome Measures

Physical Activity Questionnaire [Baseline and 6-, 12-, 24- months post-baseline]
Change in moderate to vigorous physical activity over time
NHANES Dietary Screener Questionnaire (DSQ) [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

BMI [Baseline and 6-, 12-, 24- months post-baseline]
Collection of raw BMI data for children and adults
Parenting Practices Questionnaire [Baseline and 6-, 12-, 24- months post-baseline]
Measure to assess parental investment
Parent-Adolescent Communication Scale [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
Drug Use (items from Monitoring the Future Survey) [Baseline and 6-, 12-, 24- months post-baseline]
Measure to assess frequency of adolescent drug use
Adolescent Sexual Risk Behaviors [Baseline and 6-, 12-, 24- months post-baseline]
Measure to assess adolescent sexual activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.