Healthy Juntos Pilot Study

Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

The purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among Hispanic parent-adolescent dyads.

Study Overview

• Status: Completed
• Conditions: Obesity; Sedentary Behavior; Diet, Healthy; Activity, Motor
• Intervention / Treatment: Behavioral: Healthy Juntos

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanina Pavia, MD; Phone Number: 786-643-4300; Email: vxp395@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Female and male adolescents whose primary caregiver self-identifies as Hispanic
2. Adolescent is between the ages of 12-15;
3. Adolescent lives with an adult primary caregiver willing to participate;
4. Both parent and adolescent have smartphone/mobile device with internet access;
5. Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;
6. Adolescent does not meet physical activity guidelines as determined by responses on a validated two-item screener AND self-reports engaging in >2 hours/day of screen time (proxy for overall sedentary behavior) using three items.

Exclusion Criteria:

1. Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
2. Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
3. Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
4. Parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking medications that would interfere with changes to physical activity or diet (e.g., adolescent is diagnosed with Attention Deficit Hyperactivity Disorder and is currently on stimulant medication);
5. Family is planning to move out of the South Florida during the study follow-up period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Juntos Intervention Condition; Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks.	Behavioral: Healthy Juntos; Parent-adolescent dyads will log in to a secured website for a total of eight weeks. 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 weekly 15-30 minute sessions regarding the family's progress throughout the intervention period.
No Intervention: Control Group; This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of parent-adolescent dyads retained and engaged at post-intervention (feasibility)	We will calculate the % of enrolled parent-adolescent dyads retained from baseline to 2-months post-baseline (post-intervention). We will also calculate the % of parents and adolescents randomly assigned to the intervention condition who complete all 8 weekly sessions.	2 months
Mean participant ratings on weekly session content and post-intervention open-ended feedback (acceptability)	Parents and adolescents randomly assigned to the intervention condition will rate their overall impression of each session using a 5-star rating scale; a subset of parent-adolescent dyads will also be interviewed at 2-months post-baseline to assess their acceptance of the intervention.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adolescent and parent physical activity	Adolescents will self-report their physical activity using the Youth Activity Profile. Parents will self-report their physical activity using the International Physical Activity Questionnaire.	Baseline, 2 months
Change in adolescent and parent dietary intake (i.e., fruits/vegetables, sugar)	Adolescents and parents will self-report their own dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables and teaspoon equivalents of added sugars will be calculated using a scoring algorithm developed by the National Cancer Institute.	Baseline, 2 months
Change in adolescent and parent sedentary behavior	Adolescents will self-report their sedentary behavior using the Youth Activity Profile. Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire	Baseline, 2 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sara M St George, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; family; nutrition; digital health; Hispanic; obesity prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20160415; K01HL133521 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No