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Efficacy Trial of Healthy Together ("Juntos")

ConditionsObesityActivity, MotorDiet, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-15
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Healthy Together ("Juntos")Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Body Mass Index (BMI) in adolescents

Will be measured in kg/m\^2

Time frame
Baseline and up to 12 months

Secondary outcomes

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))

Time frame
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

Time frame
Baseline and up to 12 months
3

Change in Percentage of Body Fat in adolescents

Measured in percentage

Time frame
Baseline and up to 12 months
4

Change in Body Mass Index (BMI) in parents

Will be measured in kg/m\^2

Time frame
Baseline and up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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