Healthy Juntos Pilot Study

NCT ID: NCT03986190

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2023-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy Juntos

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sara StGeorge

Assistant Professor of Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara M St George, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K01HL133521

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20160415

Identifier Type: -

Identifier Source: org_study_id