Efficacy Trial of Healthy Together ("Juntos")

NCT ID: NCT06489262

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2029-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy Together ("Juntos")

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sara StGeorge

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara St George, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara St George, PhD

Role: CONTACT

healthyjuntos@med.miami.edu

1 (305) 243-0726

Facility Contacts

Sara St George, PhD

Role: primary

s.stgeorge@med.miami.edu

305-243-0726

Other Identifiers

R01CA289519

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20231382

Identifier Type: -

Identifier Source: org_study_id