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ObesityNCT06489262

Efficacy Trial of Healthy Together ("Juntos")

A study testing Healthy Together ("Juntos") in people with Obesity and Activity, Motor, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Activity, Motor, Diet, Healthy
What is being tested?
Healthy Together ("Juntos")
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteUnited States
Study dates
28 Feb 2025to 31 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara St George, PhD contact

1 (305) 243-0726

healthyjuntos@med.miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Miami, Florida, 33136

    Sara St George, PhD, +1 (305) 243-0726, s.stgeorge@med.miami.edu

    Sara St George

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Healthy Together ("Juntos")
Keywords
Hispanic, family, digital health, obesity prevention, physical activity, nutrition
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Together ("Juntos")Behavioural

    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.

Study groups in NCT06489262
Study groupRoleWhat they receive
Healthy Together ("Juntos")ExperimentalParticipants 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.
Receives: Behavioral: Healthy Together ("Juntos")
ControlNo interventionThis group will receive a digital standard of care - a list of publicly available lifestyle apps and websites that they may access at their discretion.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Will be measured in kg/m^2

    Measured: Baseline and up to 12 months

Secondary outcomes (10)

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

    Will be measured using an Actigraph (counts/seconds (Moderate=757-1111 counts/15-seconds and vigorous>1200 counts/15-seconds))

    Measured: Baseline and up to 12 months

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

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

    Measured: Baseline and up to 12 months

  3. Change in Percentage of Body Fat in adolescents

    Measured in percentage

    Measured: Baseline and up to 12 months

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

    Will be measured in kg/m^2

    Measured: Baseline and up to 12 months

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

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

    Measured: Baseline and up to 12 months

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

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

    Measured: Baseline and up to 12 months

  7. Change in Percentage of Body Fat in parents

    Measured in percentage

    Measured: Baseline and up to 12 months

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

    Measured by parental involvement subscale of the Parenting Practices measure (4-point Likert scale, higher scores indicate higher parental involvement; parent and adolescent report)

    Measured: Baseline and up to 12 months

  9. Change in Communication measured by Parent Adolescent Communication Scale

    Measured by the Parent-Adolescent Communication Scale (5-point Likert scale, higher scores indicate more positive communication; parent and adolescent report)

    Measured: Baseline and up to 12 months

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

    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)

    Measured: Baseline and up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start28 Feb 2025
  3. Primary completion31 May 2029 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06489262
Sponsor's protocol ID
20231382
Other IDs
R01CA289519
Status last verified
Mar 2026
First submitted
28 Jun 2024
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Together ("Juntos") in people with Obesity and Activity, Motor, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara St George, PhD (1 (305) 243-0726, healthyjuntos@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) in adolescents (time frame: Baseline and up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06489262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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