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Efficacy Trial of Healthy Together ("Juntos")

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06489262
Enrollment
750
Registered
2024-07-05
Start date
2025-02-28
Completion date
2029-05-31
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Motor, Diet, Healthy, Obesity

Keywords

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

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.

Interventions

BEHAVIORALHealthy 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.

Sponsors

University of Miami
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Mass Index (BMI) in adolescentsBaseline and up to 12 monthsWill be measured in kg/m\^2

Secondary

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

Countries

United States

Contacts

CONTACTSara St George, PhD
healthyjuntos@med.miami.edu1 (305) 243-0726
PRINCIPAL_INVESTIGATORSara St George, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026