Reducing Obesity Health Disparities in Hispanic Youth

Overweight Clinical Trial

Official title:

Families Preventing and Reducing Obesity Health Disparities in Hispanic Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943628
• Other study ID #: 20130195
• Secondary ID: R01MD007724
• Status: Completed
• Phase: N/A
• Start date: January 12, 2015
• Est. completion date: December 27, 2018

Study information

• Verified date: May 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

INCLUSION CRITERIA:

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 Americas.

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 study.

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).

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Drug Use
• Family Relations
• Obesity
• Overweight
• Sexual Behavior

Intervention

Behavioral:
• Familias Unidas

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Questionnaire	Change in moderate to vigorous physical activity over time	Baseline and 6-, 12-, 24- months post-baseline
Primary	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	BMI	Collection of raw BMI data for children and adults	Baseline and 6-, 12-, 24- months post-baseline
Secondary	Parenting Practices Questionnaire	Measure to assess parental investment	Baseline and 6-, 12-, 24- months post-baseline
Secondary	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	Baseline and 6-, 12-, 24- months post-baseline
Secondary	Drug Use (items from Monitoring the Future Survey)	Measure to assess frequency of adolescent drug use	Baseline and 6-, 12-, 24- months post-baseline
Secondary	Adolescent Sexual Risk Behaviors	Measure to assess adolescent sexual activity	Baseline and 6-, 12-, 24- months post-baseline