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Healthy Juntos Pilot Study

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ClinicalTrials.gov Identifier: NCT03986190
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
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 develop an online (web and mobile-phone-based) program to improve physical activity levels, nutrition, and family functioning in Hispanic adolescents and their primary caregivers.

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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

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 are being 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 a 15-30 minute conversation with parents regarding their family's progress periodically throughout the intervention period.

No Intervention: Control Group
This group will not receive any form of intervention in the study.



Primary Outcome Measures :
  1. Change in adolescent moderate-to-vigorous physical activity [ Time Frame: Baseline, 2 months, 8 months ]
    Adolescents will self-report their physical activity using the Global Physical Activity Questionnaire (GPAQ). A summed score of recreational and transport activities in units of minutes for moderate-to-vigorous physical activity levels during a typical week will be calculated using the WHO scoring guide.

  2. Change in adolescent fruit and vegetable intake [ Time Frame: Baseline, 2 months, 8 months ]
    Adolescents will self-report their dietary intake over the previous month using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by that National Cancer Institute.

  3. Change in adolescent sedentary behavior [ Time Frame: Baseline, 2 months, 8 months ]
    Adolescents will self-report their sedentary behavior (hours/week) on a usual weekday and weekend day separately using the Sedentary Behaviors Scale. Response options range from none to 4 or more hours. A composite score of sedentary hour/week will be calculated.



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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 own a smartphone 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: Sara M St George, PhD 305-243-0726 s.stgeorge@med.miami.edu

Locations
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United States, Florida
University of Miami Not yet 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     History of Changes
Other Study ID Numbers: 20160415
K01HL133521 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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
Signs and Symptoms