Healthy Together Program for Obesity

Overseen By Sara St George, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Obesity, Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.

Who Is on the Research Team?

Sara M St. George, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Adolescent: Lives with participating biological parent or legal guardian, Self-identifies as Hispanic, Is between the ages of 12-15 years old, Has access to a smartphone, Does not meet recommendations for physical activity, Does not meet recommendations for daily fruit and vegetable intake, Exceeds recommendations for screen time

Parent: Is the biological parent or legal guardian of and lives with the adolescent, Self-identifies as Hispanic, Has access to a smartphone

Exclusion Criteria

I am a teenager with a very low or very high BMI, have a serious health condition, cognitive or developmental delays as reported by my parent.

Parent: Provides PAR-Q responses that indicate a serious health issue and physician does not approve participation, Reports family plans to move out of South Florida during the study follow-up period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Treatment

Participants receive the Healthy Together ('Juntos') digital intervention, including eight modules and coaching sessions over the first three months

12 weeks

Multiple virtual sessions

Maintenance Treatment

Participants continue with the Healthy Together ('Juntos') digital intervention, including three modules and coaching sessions over the subsequent three months

12 weeks

Multiple virtual sessions

Follow-up

Participants are monitored for changes in body mass index, physical activity, diet quality, and body fat percentage

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Together ('Juntos')

Trial Overview 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.

How Is the Trial Designed?

Group I: Healthy Together ("Juntos") Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+