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Behavioral Intervention
Healthy Together Program for Obesity
N/A
Waitlist Available
Led By Sara St George, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if a digital program called Healthy Together can help Hispanic teenagers maintain a healthy weight and improve their physical activity, diet, and body fat percentage."
Who is the study for?
This trial is for Hispanic adolescents who are interested in preventing weight gain and improving their physical activity, diet quality, and body fat percentage. Specific eligibility criteria details were not provided.
What is being tested?
The study is testing the effectiveness of 'Healthy Together' ('Juntos'), a digital program accessible via web and mobile phones designed to help families adopt healthier lifestyles.
What are the potential side effects?
Since 'Healthy Together' ('Juntos') is a lifestyle intervention program focusing on diet and exercise, it does not have side effects like medications do. However, participants may experience muscle soreness or fatigue from new physical activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Body Mass Index (BMI) in adolescents
Secondary study objectives
Change in Body Mass Index (BMI) in parents
Change in Communication measured by Parent Adolescent Communication Scale
Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Together ("Juntos")Experimental Treatment1 Intervention
Participants will receive the Healthy Together ("Juntos") digital intervention. The six-month intervention includes an "intensive" phase comprised of eight modules and coaching sessions delivered in the first three months and a "maintenance phase" comprised of three modules and coaching sessions delivered in the subsequent three months.
Group II: ControlActive Control1 Intervention
This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites that they may access at their discretion.
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Who is running the clinical trial?
University of MiamiLead Sponsor
948 Previous Clinical Trials
427,094 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,013,703 Total Patients Enrolled
Sara St George, PhDPrincipal InvestigatorUniversity of Miami
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