NCT05856149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

May 3, 2023

Results QC Date

December 16, 2025

Last Update Submit

February 3, 2026

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Percent Weight Change at Intervention Completion

    Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.

    baseline and 3 months 1 week

  • Percent Weight Change Three Months Post Intervention

    Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.

    baseline and 6 months 1 week

Secondary Outcomes (8)

  • Change in Hemoglobin A1C Levels

    baseline and 3 months 1 week

  • Change in Hemoglobin A1C Levels

    baseline and 6 months 1 week

  • Change in Diabetes Knowledge Assessment

    baseline and 3 months 1 week

  • Change in Diabetes Knowledge Assessment

    baseline and 6 months 1 week

  • Change in Eating Patterns

    baseline and 3 months 1 week

  • +3 more secondary outcomes

Study Arms (2)

STEPS

EXPERIMENTAL

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.

Behavioral: Mobile Diabetes Prevention Program

Usual Care

NO INTERVENTION

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

Interventions

Mobile Diabetes Prevention ProgramBEHAVIORAL

The intervention is a mobile, web-based diabetes prevention program that participants will have access to for a total of 12 weeks. The intervention is a behavioral intervention aimed at increasing the knowledge and skills of participants to reduce type 2 diabetes risk behaviors.

STEPS

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Language fluency in English or Spanish
  • Hispanic
  • High risk for prediabetes using the CDC's Prediabetic Screener
  • Rural county residence
  • Not currently pregnant
  • Is cleared for physical activity using the PAR-Q and/or doctor's approval
  • Currently has a smartphone with internet access

You may not qualify if:

  • \<18 years and older
  • Not fluent in English or Spanish
  • Not Hispanic
  • Not at risk for prediabetes using the CDC's Prediabetic Screener
  • Not a rural county residence
  • Is currently pregnant
  • Is not cleared for physical activity using the PAR-Q and/or doctor's approval
  • Does not currently have a smartphone with internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Action Corporation of South Texas Health Center

Alice, Texas, 78332, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Debra Rios
Organization
ISA Associates, Inc.
drios@isagroup.com
7037390462

Study Officials

  • Debra M Rios, DrPH

    ISA Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 12, 2023

Study Start

April 19, 2023

Primary Completion

November 1, 2024

Study Completion

January 31, 2025

Last Updated

February 23, 2026

Results First Posted

February 23, 2026

Record last verified: 2026-02

Locations

US(1)