Healthy Juntos Pilot Study

Not Applicable

Completed

• Conditions: Obesity; Sedentary Behavior; Activity, Motor; Diet, Healthy
• Interventions: Behavioral: Healthy Juntos

• Registration Number: NCT03986190
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-14
• Study Start: 2021-08-27
• Primary Completion: 2023-05-06
• Study Completion: 2023-05-06
• Results First Submitted: 2024-05-01
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Results First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Juntos Intervention Condition	Healthy Juntos	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.

Primary Outcome Measures

Name	Time	Method
Change in Adolescents Physical Activity	Baseline, up to 2 months	Adolescents will self-report physical activity using the Youth Activity Profile.
Change in Adolescent Sedentary Behavior	Baseline, 2 months	Adolescents will self-report sedentary behavior using the Youth Activity Profile.
Change in Adolescents Dietary Intake (Sugar)	Baseline, up to 2 months	Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)	Baseline, 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Parents Dietary Intake (Sugar)	Baseline, up to 2 months	Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Change in Parent Physical Activity.	Baseline, up to 2 months	Parents will self-report physical activity using the International Physical Activity Questionnaire.
Change Parent Sedentary Behavior	Baseline, up to 2 months	Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire
Change in Parents Dietary Intake (i.e., Fruits/Vegetables)	Baseline, up to 2 months	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States