Healthy Juntos Pilot Study

Obesity Clinical Trial

Official title:

Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986190
• Other study ID #: 20160415
• Secondary ID: K01HL133521
• Status: Completed
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: May 6, 2023

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adolescents Physical Activity	Adolescents will self-report physical activity using the Youth Activity Profile.	Baseline, up to 2 months
Primary	Change in Adolescent Sedentary Behavior	Adolescents will self-report sedentary behavior using the Youth Activity Profile.	Baseline, 2 months
Primary	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
Primary	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	Change in Parent Physical Activity.	Parents will self-report physical activity using the International Physical Activity Questionnaire.	Baseline, up to 2 months
Secondary	Change Parent Sedentary Behavior	Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire	Baseline, up to 2 months
Secondary	Change in Parents Dietary Intake (i.e., Fruits/Vegetables)	Parents 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, up to 2 months
Secondary	Change in Parents Dietary Intake (Sugar)	Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.	Baseline, up to 2 months