Fit24+ for Type 2 Diabetes Prevention

(Fit24+ Trial)

Overseen By Erica Soltero, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Steroids

Disqualifiers: Sleep apnea, Recent hospitalization, Pregnant, others

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

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent type 2 diabetes in Hispanic adolescents who encounter barriers such as transportation and busy family schedules. The program, Fit24+, uses telehealth to provide nutrition education and support through online sessions, along with a Fitbit to track activity. The trial targets Hispanic teens aged 12-16 with obesity who own a cellphone. Participants receive tools and support to improve their lifestyle, while the control group follows standard diet and activity guidelines. As an unphased trial, this study offers participants a unique opportunity to actively contribute to innovative solutions for preventing diabetes in their community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications that affect activity, sleep, or glucose metabolism, you may not be eligible to participate.

What prior data suggests that the Fit24+ program is safe for Hispanic adolescents?

Research shows that Fit24+, a digital health program, helps Hispanic teenagers with obesity improve their physical activity and sleep. Studies have found that this program uses tools like a Fitbit and text messages to assist in setting and reaching health goals.

In past studies, participants responded positively to Fit24, indicating it is a practical and acceptable way to support healthy behavior changes. The program aims to lower the risk of type 2 diabetes by encouraging more active lifestyles and better sleep habits.

No specific reports of negative effects from using Fit24 have emerged. As a digital program with wearable technology and educational materials, it is generally easy to use. The focus on improving lifestyle habits presents a low-risk way to support better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fit24+ is unique because it combines nutrition education with technology-driven support to help prevent Type 2 Diabetes. Unlike the standard treatments that often focus on medications or lifestyle advice given in-person, Fit24+ offers a digital platform with pre-recorded sessions, a discussion board, and personalized goal-setting using a Fitbit and a chatbot. This approach not only provides convenience and accessibility by being available online but also encourages ongoing engagement and personalized support, which can be crucial for long-term behavior change. Researchers are excited about this trial because it explores how digital tools can empower individuals and their families to make sustainable lifestyle changes that could prevent the onset of diabetes.

What evidence suggests that the Fit24+ program might be an effective treatment for type 2 diabetes prevention in Hispanic adolescents?

Research has shown that Fit24+, the program tested in this trial, might help prevent type 2 diabetes in Hispanic teenagers. Participants in the intervention arm will receive text messages and Fitbit devices to encourage more physical activity and better sleep. Studies have found that these methods can lower the risk of diabetes. Fit24+ is available through telehealth, which helps avoid issues like transportation or scheduling conflicts. Early results indicate that participants find Fit24+ practical and enjoyable. Overall, Fit24+ aims to support healthier lifestyle changes in a convenient and engaging way. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Hispanic adolescents aged 12-16 who are facing challenges with obesity and at risk of type 2 diabetes. It aims to help those who might have trouble accessing traditional health programs due to social or logistical barriers.

Inclusion Criteria

Self-report as Hispanic

Own his or her own cellphone

My BMI is in the top 5% for my age and gender.

Exclusion Criteria

Pregnant

Currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit

I am on medication or have a condition affecting my activity, sleep, or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Focus Groups

Adolescents and parents participate in focus groups or surveys to gather perceptions and data on technology use.

4 weeks

1 visit (virtual)

Phase 2: Expert Panel and Program Adaptation

An expert panel reviews program adaptations and provides feedback on modifications.

4 weeks

2 visits (virtual)

Phase 3: Usability Testing

Field usability testing with participants to provide feedback on nutrition education sessions and activity tracker functionality.

4 weeks

1 visit (virtual)

Intervention

Participants engage in a telehealth diabetes prevention program with nutrition and physical activity components.

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for feasibility and acceptability of the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fit24+

Trial Overview The study is testing Fit24+, a telehealth diabetes prevention program tailored for the needs of these adolescents. The goal is to see if this online approach can effectively reach and engage participants in managing their health.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Nutrition Education: There are 12 pre-recorded nutrition and well-being sessions in Spanish and English lasting 20-40 minutes and hosted on an elearning platform, Learnworlds. This is a secure platform and each participant and their family members will have a secure, unique, password protected login. The platform includes a discussion board to share challenges and successes in behavior change, a recipes tab, and message system to ask instructors questions or report technical issues. Participants will receive a Fitbit Charge and access to a chatbot developed by Mobile Coach to assist youth in setting behavioral goals and planning opportunities to be active or to improve sleep behaviors. Mid-week texts will emphasize competence by acknowledging progression towards goals, providing evidence-based strategies for increasing PA, and reinforcing content from nutrition sessions. End of week texts will provide feedback on goal attainment.

Group II: Control Active Control 1 Intervention

Youth in the control will receive a handout on diet and PA guidelines . Control youth will be given access to the nutrition education website after their participation as a control for 12-weeks. No additional data will be collected on control youth beyond the 12 week intervention period.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

The Diabetes Prevention Program (DPP) is a large-scale clinical trial aimed at preventing type 2 diabetes in high-risk individuals, with 3,048 participants recruited from a pool of over 133,000 screened, highlighting its extensive reach.

The trial includes diverse participants, with 45% from ethnic minority groups and 67% being women, ensuring a representative sample for evaluating the effectiveness of lifestyle changes and metformin in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Background and recruitment data for the U.S. Diabetes Prevention Program. Fujimoto, WY.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11143392/

Feasibility of Fit24, a Digital Diabetes Prevention Program ... This study qualitatively assessed the feasibility and acceptability of Fit24, a 12-week goal-setting intervention that uses a Fitbit watch.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36775009/

Fit24, a digital health intervention to reduce type 2 diabetes ... A 12-week intervention that uses theoretically grounded text messages and a Fitbit device to improve PA and sleep among Hispanic adolescents with obesity.

3. sciencedirect.com sciencedirect.com/science/article/am/pii/S155171442300040X

Fit24, a digital health intervention to reduce type 2 diabetes ... Discussion: This study will advance our knowledge on the feasibility of digital prevention strategies to promote PA and sleep behaviors to reduce T2D risk among.

4. researchgate.net researchgate.net/publication/380667027_Feasibility_of_Fit24_a_Digital_Diabetes_Prevention_Program_for_Hispanic_Adolescents_Qualitative_Evaluation_Study

(PDF) Feasibility of Fit24, a Digital Diabetes Prevention ... Findings from this study will inform future diabetes prevention trials of Fit24 and other digital health interventions for high-risk pediatric populations.

5. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/f2c7226e-ad67-49aa-932d-01f9b88c2d2c-MECA.pdf?abstractid=5124511&mirid=1

Fit24+, a digital diabetes prevention program for Hispanic ... ... type 2 diabetes, yet remain underrepresented in diabetes prevention research. ... feasibility and outcomes data ... with type 2 diabetes: Effective eHealth ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442300040X

Fit24, a digital health intervention to reduce type 2 diabetes ... This study will advance our knowledge on the feasibility of digital prevention strategies to promote PA and sleep behaviors to reduce T2D risk among Hispanic ...

7. formative.jmir.org formative.jmir.org/2024/1/e54595

Feasibility of Fit24, a Digital Diabetes Prevention Program for ... This study qualitatively assessed the feasibility and acceptability of Fit24, a 12-week goal-setting intervention that uses a Fitbit watch (Fitbit Inc) and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10065958/

Fit24, a digital health intervention to reduce type 2 diabetes ... A 12-week intervention that uses theoretically grounded text messages and a Fitbit device to improve PA and sleep among Hispanic adolescents with obesity.