Efficacy Trial of Healthy Together ("Juntos")
NCT Number: NCT06489262
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Activity, Motor|Diet, Healthy
Interventions: BEHAVIORAL: Healthy Together ("Juntos")
Sponsor: University of Miami
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD
Enrollment: 750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2029-05-31
Locations: University of Miami, Miami, Florida, 33136, United States

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.

Primary Outcome Measures: Change in Body Mass Index (BMI) in adolescents, Will be measured in kg/m\^2, Baseline and up to 12 months
Secondary Outcome Measures: 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)), 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, Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet, Baseline and up to 12 months|Change in Percentage of Body Fat in adolescents, Measured in percentage, Baseline and up to 12 months|Change in Body Mass Index (BMI) in parents, Will be measured in kg/m\^2, Baseline and up to 12 months|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)), 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, Healthy Eating Index scores range from 0-100, higher scores indicate a higher quality diet, Baseline and up to 12 months|Change in Percentage of Body Fat in parents, Measured in percentage, Baseline and up to 12 months|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), Baseline and up to 12 months|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), Baseline and up to 12 months|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), Baseline and up to 12 months