Efficacy Trial of Healthy Together ("Juntos")

Not Applicable

Recruiting

• Conditions: Diet, Healthy; Activity, Motor; Obesity
• Interventions: Behavioral: Healthy Together ("Juntos")

• Registration Number: NCT06489262
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-05
• Study Start: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2029-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Together ("Juntos")	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.

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI) in adolescents	Baseline and up to 12 months	Will be measured in kg/m\^2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States