Efficacy Trial of Healthy Together ("Juntos")

Efficacy Trial of Healthy Together "Juntos": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diet, Healthy; Activity, Motor
• Intervention / Treatment: Behavioral: Healthy Together ("Juntos")

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara St George, PhD; Phone Number: 1 (305) 243-0726; Email: healthyjuntos@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Sara St George
      • Contact: Sara St George, PhD; Phone Number: +1 (305) 243-0726; Email: s.stgeorge@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI) in adolescents	Will be measured in kg/m^2	Baseline and up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents	Will be measured using an Actigraph (counts/seconds (Moderate=757-1111 counts/15-seconds and vigorous>1200 counts/15-seconds))	Baseline and up to 12 months
Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool	Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet	Baseline and up to 12 months
Change in Percentage of Body Fat in adolescents	Measured in percentage	Baseline and up to 12 months
Change in Body Mass Index (BMI) in parents	Will be measured in kg/m^2	Baseline and up to 12 months
Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents	Will be measured using an Actigraph (in counts/minutes (Moderate=2690-6166 - counts/minute; vigorous≥6167 counts/min))	Baseline and up to 12 months
Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool	Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet	Baseline and up to 12 months
Change in Percentage of Body Fat in parents	Measured in percentage	Baseline and up to 12 months
Change in Parenting Practices measured by the Parental involvement Scale	Measured by parental involvement subscale of the Parenting Practices measure (4-point Likert scale, higher scores indicate higher parental involvement; parent and adolescent report)	Baseline and up to 12 months
Change in Communication measured by Parent Adolescent Communication Scale	Measured by the Parent-Adolescent Communication Scale (5-point Likert scale, higher scores indicate more positive communication; parent and adolescent report)	Baseline and up to 12 months
Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale	Measured by the Parenting Strategies for Eating and Activity Scale (5-point Likert scale, higher scores indicate more use of parent strategies for heathy eating and activity; parent and adolescent report)	Baseline and up to 12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sara St George, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hispanic, family, digital health, obesity prevention, physical activity, nutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Motor Activity
• Other Study ID Numbers: 20231382; R01CA289519 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No