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

Trial Summary

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 data supports the effectiveness of the treatment Fit24+ for preventing type 2 diabetes?

Research shows that lifestyle interventions, especially when combined with a low-carbohydrate diet, can significantly reduce the risk of developing type 2 diabetes in people with prediabetes. This suggests that treatments like Fit24+, which may include similar components, could be effective in diabetes prevention. ^{1 2 3 4 5}

What safety data exists for Fit24+ or similar treatments in humans?

In a diabetes prevention study, a treatment group using a drug called troglitazone was discontinued due to liver toxicity, highlighting the importance of monitoring for adverse effects in similar treatments. ^{1 2 6 7 8}

What makes the Fit24+ treatment unique for preventing type 2 diabetes?

The Fit24+ treatment is unique because it likely incorporates a comprehensive lifestyle approach, focusing on physical activity and possibly dietary changes, to prevent type 2 diabetes, rather than relying solely on medication. This approach aligns with evidence showing that regular physical activity and lifestyle modifications are effective in reducing diabetes risk. ^{9 10 11 12 13}

What is the purpose of this trial?

Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics of participants in the Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of screen and treat policies in prevention of type 2 diabetes: systematic review and meta-analysis of screening tests and interventions. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention-A 12-Month Subanalysis of the ACOORH Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of AUSDRISK as a screening tool for lifestyle modification programs: international implications for policy and cost-effectiveness. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Uptake and impact of the English National Health Service digital diabetes prevention programme: observational study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Canada pubmed.ncbi.nlm.nih.gov

"It's a Life Thing, Not a Few Months Thing": Profiling Patterns of the Physical Activity Change Process and Associated Strategies of Women With Prediabetes Over 1 Year. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Epidemiological studies of exercise in diabetes prevention. [2016]

11. Switzerland pubmed.ncbi.nlm.nih.gov

PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Physical activity and insulin sensitivity: the RISC study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Physical activity intervention for rural middle-aged and older Australian adults: a pilot implementation study of the ecofit program delivered in a real-world setting. [2021]