Mobile Diabetes Prevention Program for Type 2 Diabetes

Overseen By DEBRA M RIOS, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ISA Associates, Inc.

Disqualifiers: Under 18, Not Hispanic, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile program called STEPS can reduce the risk of Type 2 Diabetes in Hispanic individuals living in rural areas. Participants will either use the STEPS program, a web-based diabetes prevention tool, or continue with their usual care for three months. The trial aims to determine if STEPS leads to more weight loss and better health outcomes compared to not using it. Hispanic individuals living in rural areas who are at high risk for prediabetes may be suitable candidates if they have a smartphone with internet access. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health solutions for the community.

Do I have to stop taking my current medications for the trial?

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 this mobile diabetes prevention program is safe?

Research shows that lifestyle change programs like STEPS are generally safe for people. Studies on similar programs have found that they help reduce the risk of developing type 2 diabetes by promoting healthy habits, such as losing weight and exercising regularly. For example, the Diabetes Prevention Program (DPP) successfully lowered diabetes risk by 58% in participants who followed its guidelines.

These programs focus on encouraging healthier lifestyles instead of using medication, often resulting in fewer side effects. Research on these types of programs has not reported any serious negative effects. Most participants handle the programs well. As always, discussing participation with a healthcare provider is important to ensure the trial aligns with individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mobile Diabetes Prevention Program, called STEPS, is unique because it leverages a digital platform to help prevent type 2 diabetes, offering a new approach compared to traditional in-person counseling or medication. Researchers are excited about this program because it allows participants to access all resources and tools online, making it more convenient and accessible, particularly for those with busy schedules or limited access to healthcare facilities. Unlike standard care options, which may include lifestyle interventions delivered in person or medications like metformin, STEPS provides a flexible, web-based solution that could potentially reach a broader audience and encourage sustained lifestyle changes.

What evidence suggests that this mobile diabetes prevention program is effective for reducing the risk of Type 2 Diabetes in rural Hispanics?

Research has shown that mobile programs can help prevent Type 2 Diabetes. One study found that people using a mobile program lost more weight over a year compared to those receiving regular care. Another study showed that similar lifestyle changes reduced the risk of diabetes by 58%. Participants in these programs often lose weight and body fat. This trial will compare the effectiveness of the mobile, web-based diabetes prevention program, STEPS, with usual care. This evidence suggests that using a mobile program could lower the chances of developing Type 2 Diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Debra M Rios, DrPH

Principal Investigator

ISA Associates

Are You a Good Fit for This Trial?

This trial is for Hispanic adults living in rural areas who are at high risk for Type 2 Diabetes, as determined by the CDC's Prediabetic Screener. Participants must be over 18, fluent in English or Spanish, have a smartphone with internet access, and be cleared for physical activity. Pregnant individuals or those not at prediabetes risk are excluded.

Inclusion Criteria

This criterion does not provide enough context for me to rewrite it. Can you please provide more information or clarify the context?

You have a high risk for developing prediabetes according to the CDC's prediabetes test.

Currently has a smartphone with internet access

Exclusion Criteria

You are not at risk for prediabetes according to the CDC's Prediabetic Screener.

Not Hispanic

Does not currently have a smartphone with internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the STEPS intervention or usual care for a total of three months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes such as weight change and diabetes diagnosis

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Diabetes Prevention Program

Trial Overview The study tests a mobile web-based diabetes prevention program called STEPS against usual care to see if it reduces Type II Diabetes risk in rural Hispanics. It's a randomized controlled trial where outcomes like weight loss will be compared after three and six months.

How Is the Trial Designed?

Group I: STEPS Experimental Treatment 1 Intervention

Participants will have access to the mobile, web-based diabetes prevention program-- STEPS--for a total of three months or twelve weeks. They will be able to access all program modules and tools during this period.

Group II: Usual Care Active Control 1 Intervention

Participants in the Usual Care control group will not receive an intervention.

Who Is Running the Clinical Trial?

ISA Associates, Inc.

Lead Sponsor

Trials

6

Recruited

920+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32459631/

Mobile Delivery of the Diabetes Prevention Program in ... Conclusions: This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618152/

Advancing Type 2 Diabetes Prevention through Text ... A total of 12% of the intervention group and 11% of the control group achieved the Healthy Lifestyle Outcome (a composite score of weight, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125000694

a systematic review and meta-analysis of interventions The study showed that participants achieved a significant reduction in body weight of 7.5 %, in percent body fat (ranging from −6.0 % to −5.4 %) and visceral ...

5. mhealth.jmir.org mhealth.jmir.org/2020/7/e17842

Mobile Delivery of the Diabetes Prevention Program in People ... Outcomes. Primary outcome measures included a change in weight and HbA1c levels at 6 and 12 months from the start of the program. The CDC's ...

6. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

7. diabetes.org diabetes.org/newsroom/new-data-from-diabetes-prevention-program-outcomes-study-shows-persistent-reduction-of-t2d-development-over-22-year-average-follow-up

New Data from Diabetes Prevention Program Outcomes ... The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125000232

Digital technologies for prediabetes: A systematic review ... Individuals with prediabetes are at a significant risk of developing type 2 diabetes mellitus (T2DM) along with the severe and life-threatening complications of ...