Efficacy Trial of Healthy Together ("Juntos")

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06489262
Status
Recruiting
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Conditions

  • Activity, Motor
  • Diet, Healthy
  • Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 15 Years
Healthy Volunteers
Accepted

Interventions

  • Healthy Together ("Juntos") — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Healthy Together ("Juntos")
    Participants will receive the Healthy Together ("Juntos") digital intervention. The six-month intervention includes an "intensive" phase comprised of eight modules and coaching sessions delivered in the first three months and a "maintenance phase" comprised of three modules and coaching sessions delivered in the subsequent three months.
  • No Intervention: Control
    This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites that they may access at their discretion.

Primary Outcome Measure

Change in Body Mass Index (BMI) in adolescents [ Time Frame: Baseline and up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Sara St George, PhD
[email protected]
+1 (305) 243-0726
Sara St George (PRINCIPAL_INVESTIGATOR)

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