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NCT Number: NCT06489262

Efficacy Trial of Healthy Together ("Juntos")

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.

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Key information

Conditions

Obesity Activity, Motor Behavior Body Weight Diet, Healthy Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Sara St George

PRINCIPAL_INVESTIGATOR

Sara St George, PhD

CONTACT

[email protected]

+1 (305) 243-0726

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Body Mass Index (BMI) in adolescents

    Time frame: Baseline and up to 12 months

    Will be measured in kg/m^2

Secondary outcomes

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

    Time frame: 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))

  2. Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool

    Time frame: Baseline and up to 12 months

    Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet

  3. Change in Percentage of Body Fat in adolescents

    Time frame: Baseline and up to 12 months

    Measured in percentage

  4. Change in Body Mass Index (BMI) in parents

    Time frame: Baseline and up to 12 months

    Will be measured in kg/m^2

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

    Time frame: Baseline and up to 12 months

    Will be measured using an Actigraph (in counts/minutes (Moderate=2690-6166 - counts/minute; vigorous≥6167 counts/min))

  6. Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool

    Time frame: Baseline and up to 12 months

    Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet

  7. Change in Percentage of Body Fat in parents

    Time frame: Baseline and up to 12 months

    Measured in percentage

  8. Change in Parenting Practices measured by the Parental involvement Scale

    Time frame: 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)

  9. Change in Communication measured by Parent Adolescent Communication Scale

    Time frame: 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)

  10. Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sara St George, PhD

CONTACT

[email protected]

1 (305) 243-0726

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 5, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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