University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT03943628
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.
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Notify Me12 year–15 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: Baseline and 6-, 12-, 24- months post-baseline
Change in moderate to vigorous physical activity over time
Time frame: 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.
Time frame: Baseline and 6-, 12-, 24- months post-baseline
Collection of raw BMI data for children and adults
Time frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess parental investment
Time frame: 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
Time frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess frequency of adolescent drug use
Time frame: Baseline and 6-, 12-, 24- months post-baseline
Measure to assess adolescent sexual activity
University of Miami
Other
Families Preventing and Reducing Obesity Health Disparities in Hispanic Youth
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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