Status:
RECRUITING
Efficacy Trial of Healthy Together ("Juntos")
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Obesity
Activity, Motor
Eligibility:
All Genders
12-15 years
Phase:
NA
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06489262
Start Date
February 28 2025
End Date
May 31 2029
Last Update
March 4 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136