Efficacy Trial of Healthy Together ("Juntos")

Last updated: March 3, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Healthy Together ("Juntos")

Clinical Study ID

NCT06489262
20231382
R01CA289519
  • Ages 12-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 dietquality) as determined by a validated 2-item screener;

  7. Exceeds recommendations for screen time (proxy for sedentary behavior) as determinedby 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

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) thatrequires 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 approveparticipation;

  4. Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) thatmay interfere with understanding program materials.

Parent

  1. Provides PAR-Q responses that indicate a serious health issue and a physician doesnot approve participation;

  2. Reports family plans to move out of South Florida during the study follow-up period

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: Healthy Together ("Juntos")
Phase:
Study Start date:
February 28, 2025
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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