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
|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|
|Actual Study Start Date :||August 27, 2021|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
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.
- 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.
- 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.
- 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.
- 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.
- 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
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: Vanina Pavia, MDemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|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|