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

179 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this Randomized Controlled Trial (RCT) is to test the effectiveness of a mobile, web-based diabetes prevention program for Hispanics living in rural communities. The main question it aims to answer is: Does STEPS, a mobile, web-based diabetes prevention program, reduce the risk of Type II Diabetes in rural Hispanics compared to usual care? Participants will be randomly assigned to receive either the mobile STEPS intervention or usual care for a total of three months. Researchers will compare percentage weight loss, and additional outcome measures in participants of both groups at months three and six post-baseline.

Research Team

Debra M Rios, DrPH

Principal Investigator

ISA Associates

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+