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 : December 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Activity, Motor Diet, Healthy Sedentary Behavior||Behavioral: Healthy Juntos||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
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.
- 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.
- 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.
- 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.
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
|Contact: Sara M St George, PhDemail@example.com|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Contact: Sara M St. George, PhD 305-243-0726 firstname.lastname@example.org|
|Principal Investigator: Sara M St. George, PhD|
|Principal Investigator:||Sara M St George, PhD||University of Miami|