RecruitingNot ApplicableNCT06489262

Efficacy Trial of Healthy Together ("Juntos")

Efficacy Trial of Healthy Together "Juntos": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents


Sponsor

University of Miami

Enrollment

750 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.


Eligibility

Min Age: 12 YearsMax Age: 15 Years

Inclusion Criteria12

  • Adolescent
  • Lives with participating biological parent or legal guardian;
  • Self-identifies as Hispanic;
  • Is between the ages of 12-15years old;
  • Has access to a smartphone;
  • Does not meet recommendations for physical activity as determined by a validated 2-item screener;
  • Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;
  • Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener
  • Parent
  • Is the biological parent or legal guardian of and lives with the adolescent;
  • Self-identifies as Hispanic;
  • Has access to a smartphone;

Exclusion Criteria8

  • Adolescent
  • Has BMI \<5th (underweight) or ≥95th percentile (obesity);
  • Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
  • Has parent-reported responses on a physical activity readiness questionnaire (PAR-Q) that indicates a serious health issue, and a physician does not approve participation;
  • Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.
  • Parent
  • Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
  • Reports family plans to move out of South Florida during the study follow-up period

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Interventions

BEHAVIORALHealthy Together ("Juntos")

Parent-adolescent dyads will log in to a secured website for six months. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in approximately weekly (during the first 3 months), and monthly (during the following 3 months) 20-30-minute sessions regarding the family's progress throughout the intervention period.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06489262


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