Healthy Juntos Pilot Study

NCT03986190 | Completed Results

• 2 other identifiers: 20160415K01HL133521
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Activity, Motor; Diet, Healthy; Sedentary Behavior

Keywords

Hispanic; family; digital health; obesity prevention; physical activity; nutrition

Outcome Measures

Primary Outcomes (4)

• Change in Adolescents Physical Activity

  Adolescents will self-report physical activity using the Youth Activity Profile.

  Baseline, up to 2 months

• Change in Adolescent Sedentary Behavior

  Adolescents will self-report sedentary behavior using the Youth Activity Profile.

  Baseline, 2 months

• Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)

  Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute.

  Baseline, 2 months

• Change in Adolescents Dietary Intake (Sugar)

  Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.

  Baseline, up to 2 months

Secondary Outcomes (4)

• Change in Parent Physical Activity.

  Baseline, up to 2 months

• Change Parent Sedentary Behavior

  Baseline, up to 2 months

• Change in Parents Dietary Intake (i.e., Fruits/Vegetables)

  Baseline, up to 2 months

• Change in Parents Dietary Intake (Sugar)

  Baseline, up to 2 months

Study Arms (2)

Healthy Juntos Intervention Condition

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Healthy Juntos BEHAVIORAL

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.

Healthy Juntos Intervention Condition

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male adolescents whose primary caregiver self-identifies as Hispanic
• Adolescent is between the ages of 12-15;
• Adolescent lives with an adult primary caregiver willing to participate;
• Both parent and adolescent have smartphone/mobile device with internet access;
• Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;
• 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.

You may not qualify if:

• Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
• Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
• Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
• 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);
• Family is planning to move out of the South Florida during the study follow-up period

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Sara St George
• Organization: University of Miami Miller School of Medicine

s.stgeorge@med.miami.edu

305-243-0726

Study Officials

• Sara M St George, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Public Health Sciences

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: August 27, 2021
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)