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Healthy Juntos Pilot Study

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ClinicalTrials.gov Identifier: NCT03986190
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sara StGeorge, 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.

Condition or disease Intervention/treatment Phase
Obesity Activity, Motor Diet, Healthy Sedentary Behavior Behavioral: Healthy Juntos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

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.



Primary Outcome Measures :
  1. Percent of parent-adolescent dyads retained and engaged at post-intervention (feasibility) [ Time Frame: 2 months ]
    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. Mean participant ratings on weekly session content and post-intervention open-ended feedback (acceptability) [ Time Frame: 2 months ]
    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.


Secondary Outcome Measures :
  1. Change in adolescent and parent physical activity [ Time Frame: Baseline, 2 months ]
    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.

  2. Change in adolescent and parent dietary intake (i.e., fruits/vegetables, sugar) [ Time Frame: Baseline, 2 months ]
    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.

  3. Change in adolescent and parent sedentary behavior [ Time Frame: Baseline, 2 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986190


Contacts
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Contact: Vanina Pavia, MD 786-643-4300 vxp395@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sara M St. George, PhD    305-243-0726    s.stgeorge@med.miami.edu   
Principal Investigator: Sara M St. George, PhD         
Sponsors and Collaborators
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sara M St George, PhD University of Miami
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Responsible Party: Sara StGeorge, Assistant Professor of Public Health Sciences, University of Miami
ClinicalTrials.gov Identifier: NCT03986190    
Other Study ID Numbers: 20160415
K01HL133521 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara StGeorge, University of Miami:
Hispanic
family
digital health
obesity prevention
physical activity
nutrition
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight