Clinical trial NCT06489262: Efficacy Trial of Healthy Together ("Juntos")
Official title: Efficacy Trial of Healthy Together "Juntos": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Activity, Motor
Diet, Healthy
Keywords: Hispanic, family, digital health, obesity prevention, physical activity, nutrition
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-05
Enrollment: 750
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

Adolescent

1. Lives with participating biological parent or legal guardian;
2. Self-identifies as Hispanic;
3. Is between the ages of 12-15years old;
4. Has access to a smartphone;
5. Does not meet recommendations for physical activity as determined by a validated 2-item screener;
6. Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;
7. Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener

Parent

1. Is the biological parent or legal guardian of and lives with the adolescent;
2. Self-identifies as Hispanic;
3. Has access to a smartphone;

Exclusion Criteria:

Adolescent

1. Has BMI \<5th (underweight) or ≥95th percentile (obesity);
2. Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
3. 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;
4. Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.

Parent

1. Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
2. Reports family plans to move out of South Florida during the study follow-up period

Primary outcomes:
measure: Change in Body Mass Index (BMI) in adolescents
timeFrame: Baseline and up to 12 months
Secondary outcomes:
measure: Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents
timeFrame: Baseline and up to 12 months
measure: Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
timeFrame: Baseline and up to 12 months
measure: Change in Percentage of Body Fat in adolescents
timeFrame: Baseline and up to 12 months
measure: Change in Body Mass Index (BMI) in parents
timeFrame: Baseline and up to 12 months
measure: Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents
timeFrame: Baseline and up to 12 months
measure: Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
timeFrame: Baseline and up to 12 months
measure: Change in Percentage of Body Fat in parents
timeFrame: Baseline and up to 12 months
measure: Change in Parenting Practices measured by the Parental involvement Scale
timeFrame: Baseline and up to 12 months
measure: Change in Communication measured by Parent Adolescent Communication Scale
timeFrame: Baseline and up to 12 months
measure: Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale
timeFrame: Baseline and up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sara St George, PhD
role: PRINCIPAL_INVESTIGATOR
References: