STEPS for Type 2 Diabetes

Community Action Corporation of South Texas Health Center, Alice, TX
Type 2 DiabetesMobile Diabetes Prevention Program - Behavioral
Eligibility
18 - 99
All Sexes
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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.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: baseline and 6 months 1 week

3 months 1 week
Program Evaluation - Program Satisfaction
Month 3
Change in Self-Reported Health
Percent weight change at intervention completion
Month 6
Change in Diabetes Diagnosis
Change in Diabetes Knowledge Assessment
Change in Dietary behaviors - Hispanic Dietary Assessment
Change in Eating Patterns
Change in Hemoglobin A1C levels
Change in Interpersonal Support Scale
Change in Objectively Measured Physical Activity using Fitbits
Change in Perceived Stress Scale
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
Change in Self Reported Health
Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
Change in body mass index
Percent weight change three months post intervention
Stages of Change

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Usual Care
1 of 2
STEPS
1 of 2

Active Control

Experimental Treatment

165 Total Participants · 2 Treatment Groups

Primary Treatment: STEPS · No Placebo Group · N/A

STEPS
Behavioral
Experimental Group · 1 Intervention: Mobile Diabetes Prevention Program · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months 1 week

Who is running the clinical trial?

ISA Associates, Inc.Lead Sponsor
3 Previous Clinical Trials
530 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
316 Previous Clinical Trials
1,322,828 Total Patients Enrolled
Debra M Rios, DrPHPrincipal InvestigatorISA Associates

Eligibility Criteria

Age 18 - 99 · All Participants · 8 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.