NOT_YET_RECRUITING
Efficacy Trial of Healthy Together ("Juntos")
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.
Conditions:
🦠 Obesity 🦠 Activity, Motor 🦠 Diet, Healthy
🗓️ Study Start (Actual) 1 January 2025
🗓️ Primary Completion (Estimated) 31 May 2029
✅ Study Completion (Estimated) 31 May 2029
👥 Enrollment (Estimated) 750
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • Adolescent
    • 1. Has BMI \<5th (underweight) or ≥95th percentile (obesity);
    • 2. Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
    • 3. 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;
    • 4. Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.
    • Parent
    • 1. Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
    • 2. Reports family plans to move out of South Florida during the study follow-up period
Ages Eligible for Study: 12 Years to 15 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 June 2024
  • First Submitted that Met QC Criteria 28 June 2024
  • First Posted 5 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 5 July 2024
  • Last Verified June 2024