Efficacy Trial of Healthy Together ("Juntos")

NCT06489262 | Recruiting

• 2 other identifiers: 20231382R01CA289519
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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

Diet, Healthy; Obesity; Activity, Motor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI) in adolescents

  Will be measured in kg/m\^2

  Baseline and up to 12 months

Secondary Outcomes (10)

• Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents

  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

  Baseline and up to 12 months

• Change in Percentage of Body Fat in adolescents

  Baseline and up to 12 months

• Change in Body Mass Index (BMI) in parents

  Baseline and up to 12 months

• Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents

  Baseline and up to 12 months

Study Arms (2)

Healthy Together ("Juntos")

EXPERIMENTAL

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")

Control

NO INTERVENTION

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") 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.

Healthy Together ("Juntos")

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Sara St George, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara St George, PhD

CONTACT

1 (305) 243-0726; healthyjuntos@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)