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Mobile Diabetes Prevention Program for Type 2 Diabetes

N/A
Recruiting
Led By Debra M Rios, DrPH
Research Sponsored by ISA Associates, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months 1 week
Awards & highlights

Study Summary

This trial will test if a mobile, web-based program could reduce Type II Diabetes risk among rural Hispanics compared to usual care. Participants will be monitored for 3 and 6 months.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes through a digital platform rather than medication, typical drug side effects aren't expected. However, participants may experience discomfort from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent weight change at intervention completion
Percent weight change three months post intervention
Secondary outcome measures
Change in Diabetes Diagnosis
Change in Diabetes Knowledge Assessment
Change in Dietary behaviors - Hispanic Dietary Assessment
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STEPSExperimental Treatment1 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 CareActive Control1 Intervention
Participants in the Usual Care control group will not receive an intervention.

Find a Location

Who is running the clinical trial?

ISA Associates, Inc.Lead Sponsor
4 Previous Clinical Trials
684 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
382 Previous Clinical Trials
1,215,996 Total Patients Enrolled
Debra M Rios, DrPHPrincipal InvestigatorISA Associates

Media Library

Mobile Diabetes Prevention Program Clinical Trial Eligibility Overview. Trial Name: NCT05856149 — N/A
Type 2 Diabetes Research Study Groups: STEPS, Usual Care
Type 2 Diabetes Clinical Trial 2023: Mobile Diabetes Prevention Program Highlights & Side Effects. Trial Name: NCT05856149 — N/A
Mobile Diabetes Prevention Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856149 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to partake in this medical study?

"In order to be qualified, patients should have type 2 diabetes and span the ages of 18-99. This medical trial is currently recruiting up to 165 participants."

Answered by AI

Does this experimental protocol accept elderly participants?

"This trial mandates that those enrolled must be over the age of consent, but no older than 99 years old."

Answered by AI

Are any recruitment slots still available for participants of this trial?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was first posted on April 19th 2023 is actively recruiting subjects for participation. This investigation aims to recruit 165 patients from a single site location."

Answered by AI

How many individuals are participating in the ongoing clinical trial?

"Indeed, the information on clinicaltrials.gov affirms that this investigation is currently recruiting volunteers. This trial was initially publicized on April 19th 2023 and has since been modified on May 11th of the same year. 165 individuals are desired by one site for enrolment in this study."

Answered by AI

What objectives are researchers seeking to accomplish with this study?

"This investigation, with a timeline spanning baseline to 3 months 1 week post-intervention, aims to gauge the percentage of weight change. Other measures that will be observed include alteration in Hemoglobin A1C levels (determined by an at-home test yielding results within five minutes), dietary habit modification as per the Hispanic Dietary Assessment (a 24 item survey which assigns scores from 0 to 34 where lower is healthier) and augmentation in diabetes knowledge via a 20 question true or false quiz."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Mobile Diabetes Prevention for Hispanics Living in Rural Areas
Debra Rios 2023. "Mobile Diabetes Prevention for Hispanics Living in Rural Areas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856149.
~82 spots leftby Apr 2025
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