Menu
Recruiting NCT06489262

Efficacy Trial of Healthy Together ("Juntos")

No phase Interventional Obesity Activity, Motor Diet, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Together ("Juntos").
Who it may be relevant to
Registry conditions: Obesity, Activity, Motor, Diet, Healthy. Basic parameters: 12 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral 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

Primary outcome measures

  • Change in Body Mass Index (BMI) in adolescents [Time frame: Baseline and up to 12 months]
Secondary outcome measures (10)
  • Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents [Time frame: Baseline and up to 12 months]
  • 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]
  • Change in Percentage of Body Fat in adolescents [Time frame: Baseline and up to 12 months]
  • Change in Body Mass Index (BMI) in parents [Time frame: Baseline and up to 12 months]
  • Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents [Time frame: Baseline and up to 12 months]
  • 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]
  • Change in Percentage of Body Fat in parents [Time frame: Baseline and up to 12 months]
  • Change in Parenting Practices measured by the Parental involvement Scale [Time frame: Baseline and up to 12 months]
  • Change in Communication measured by Parent Adolescent Communication Scale [Time frame: Baseline and up to 12 months]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06489262 · 20231382 · R01CA289519

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗