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 trial aims to test a digital program called "Healthy Together" to help Hispanic teens maintain a healthy weight and improve their physical activity and diet. The program provides coaching and modules over six months to guide participants in making better lifestyle choices. Hispanic teens who live with a parent or guardian, have a smartphone, and struggle with regular exercise or healthy eating may be a good fit for this study. Participants will either use the "Healthy Together" program or access a list of lifestyle apps and websites. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could positively impact their community's health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Healthy Together program is safe for adolescents?

Research has shown that digital lifestyle programs like Healthy Together ("Juntos") are generally safe. These programs aim to improve diet and exercise habits, which typically carry low risks. The primary goal is to help participants make healthier choices using online and mobile tools.

As a digital program, it involves no medications or physical treatments, reducing the chance of physical side effects. Similar programs have reported no serious problems. Participants might find it challenging to maintain commitment, but this is common with lifestyle changes and poses no health risk.

Overall, Healthy Together is expected to be easy to follow, with risks more related to motivation than safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Together ("Juntos") program because it offers a fresh, digital approach to tackling obesity. Unlike traditional methods that often involve in-person meetings or rigid diet plans, this program is delivered entirely online, providing flexibility and accessibility for participants. The program features an "intensive" phase with eight interactive modules and coaching sessions, offering personalized guidance in the initial months. This is followed by a "maintenance phase" to help sustain progress, which is a unique aspect that aims to support long-term lifestyle changes. By integrating digital tools and personalized support, this program has the potential to make managing obesity more convenient and effective for many people.

What evidence suggests that the Healthy Together program is effective for obesity?

Research has shown that the Healthy Together ("Juntos") program, which participants in this trial may receive, helps people become more active and eat healthier. One study found that participants exercised more and improved their diets. The program also strengthened family bonds, supporting lasting lifestyle changes. Another study found that digital health programs like this one can help teenagers lose weight effectively. These findings suggest the program could be helpful in managing obesity and related health issues. ^{1 2 3 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06489262

NCT06489262 | Efficacy Trial of Healthy Together ("Juntos") 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 ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09737-8

A RE-AIM evaluation of Healthy Together - BMC Public Health Effectiveness was demonstrated in reported improvements in physical activity, healthy eating, and strengthened social connections. HT was also ...

3. ctv.veeva.com ctv.veeva.com/study/efficacy-trial-of-healthy-together-juntos

Efficacy Trial of Healthy Together ("Juntos") 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06489262/efficacy-trial-of-healthy-together-juntos

Efficacy Trial of Healthy Together ("Juntos") 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8236388/

Effectiveness of a Weight Loss Program Using Digital Health ... Conclusions: An entirely remote digital weight loss program is effective in facilitating weight loss in adolescents with overweight or obesity ...

6. reporter.nih.gov reporter.nih.gov/project-details/11113818

A Family-based Digital Lifestyle Intervention for Hispanic ... PROJECT SUMMARY Obesity, physical inactivity, and poor diet are major modifiable risk factors for cancer — a leading cause of death among US Hispanics.