Recruiting

Healthy Together

Sponsor:

University of Miami

Code:

NCT06489262

Conditions

Obesity

Activity, Motor

Diet, Healthy

Eligibility Criteria

Sex: All

Age: 12 - 15

Healthy Volunteers: Accepted

Interventions

Healthy Together ("Juntos")

Study Details

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 improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.

Conditions

Obesity

Activity, Motor

Diet, Healthy

Study ID

NCT06489262

Start date

Feb 28, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 15

Healthy Volunteers: Accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Healthy 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Sara St George

More Information

Sponsor

University of Miami

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Hispanic, family, digital health, obesity prevention, physical activity, nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-23.