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Type 2 DiabetesNCT05856149

Mobile Diabetes Prevention for Hispanics Living in Rural Areas

A study testing Mobile Diabetes Prevention Program in people with Type 2 Diabetes, run by ISA Associates, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
Mobile Diabetes Prevention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 siteUnited States
Study dates
19 Apr 2023to 31 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 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

Who cannot join

  • <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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Community Action Corporation of South Texas Health Center

    Alice, Texas, 78332

Other trials in United States

About this study

Official title: Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach

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.

Read the detailed description

Behavioral interventions have been successful in reducing and delaying diabetes by targeting weight loss through modifiable behaviors (e.g., diet and exercise). There remain significant difficulties implementing Diabetes Prevention Programs (DPP) in certain populations due to access and resource availability. The health disparities seen between individuals living in rural communities versus metropolitan areas are evident. Rural communities have a 17 percent higher rate of type 2 diabetes compared to their urban counterparts.

Previous efforts to culturally adapt the DPP for Hispanics are vital, yet critical gaps remain. Specifically, insufficient attention has been paid to rural Hispanic populations and the formidable barriers these individuals face. The investigators intend to fill this gap. ISA Associates has developed a mobile web-based diabetes prevention program for Hispanic Americans living in rural communities. STEPS: Small Changes to Prevent Diabetes will be designed to increase knowledge and skills to help change lifestyle factors associated with diabetes in rural Hispanic adults. STEPS will also deliver culturally tailored information to users. The program provides users with the information, skills, and tools needed to promote health and reduce risk for the development of diabetes. Materials will be multi-modal in format (e.g., narration by a program 'coach', culturally-appropriate visuals, graphics, interactive assessments with feedback, and tailoring of information). The goal of the program will be to promote self-management of diet and physical activity and minimize risks associated with diabetes.

The investigators plan to test the effectiveness of STEPS in a randomized controlled trial with 165 Hispanic adults. Inclusion criteria are as follows: 18 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 Physical Activity Readiness Questionnaire (PAR-Q) and/or doctor's approval; and currently has a smartphone with internet access.

Individuals who are interested in participating in the study will be provided with contact information for the study. Once they initiate contact with study staff, they will learn more about the study if they choose to proceed. If they choose to proceed, they will be screened for eligibility. If they are not eligible, they will be thanked for their time. If an individual is eligible to participate, they will be scheduled for a study appointment at a Community Action of South Texas (CACOST) health center. Once they arrive for their appointment, they will receive a consent form and a study staff member will provide them details on the study and the consent form. If a participant does not consent, they will be thanked for their time and participation will not commence. If a participant consents to participate, they will then receive anthropometric screening and will complete a study questionnaire on a research tablet. Study questionnaires will take an estimated 40 minutes to complete. Once a participant completes the questionnaire, the investigators will then indicate which group they fall into (Intervention: STEPS or Control: Usual Care) and provide them with further study information.

Participants in the intervention group will have access to STEPS for a total of three months. Control participants will have access to the STEPS program once the study is complete. Before, 3-months 1 week post randomization, and 6-months 1 week post randomization, the investigators will assess anthropometric data including height, weight, a1c; demographic data, diabetes risk and knowledge, dietary intake, self-report physical activity, objective measured physical activity, self-efficacy, dietary and weight loss self-efficacy, stress, and social support.

Conditions
Type 2 Diabetes
Being tested
Mobile Diabetes Prevention Program
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Diabetes Prevention ProgramBehavioural

    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.

Study groups in NCT05856149
Study groupRoleWhat they receive
STEPSExperimentalParticipants 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.
Receives: Behavioral: Mobile Diabetes Prevention Program
Usual CareNo interventionParticipants in the Usual Care control group will not receive an intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 3 months 1 week

  2. 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.

    Measured: baseline and 6 months 1 week

Secondary outcomes (8)
  1. Change in Hemoglobin A1C Levels

    A rapid A1C self-administered test will be conducted at every study visit using an A1CNow Self Check. This at-home test delivers results in five minutes.

    Measured: baseline and 3 months 1 week

  2. Change in Hemoglobin A1C Levels

    A rapid A1C self-administered test will be conducted at every study visit using an A1CNow Self Check. This at-home test delivers results in five minutes.

    Measured: baseline and 6 months 1 week

  3. Change in Diabetes Knowledge Assessment

    Diabetes Knowledge Assessment: A 20-item measure will assess knowledge gained due to the intervention. This measure was create by the study PI, based on the contents of the intervention. The questions are answered using true or false indicators. Each correct score receives 1-point for a total score of 20 being the highest achievable score and 0 being the lowest achievable score. The higher the score, the more knowledge the participant presents.

    Measured: baseline and 3 months 1 week

  4. Change in Diabetes Knowledge Assessment

    Diabetes Knowledge Assessment: A 20-item measure will assess knowledge gained due to the intervention. This measure was create by the study PI, based on the contents of the intervention. The questions are answered using true or false indicators. Each correct score receives 1-point for a total score of 20 being the highest achievable score and 0 being the lowest achievable score. The higher the score, the more knowledge the participant presents.

    Measured: baseline and 6 months 1 week

  5. Change in Eating Patterns

    This 10-item subscale is part of the Weight Control Assessment scale aim to measure food patterns as eating too much or in between meals. This scale asks participants to recall their behavior in the past 30 days. A Likert-scale: a)almost always, b)sometimes, c)rarely, and d)never, are provided for each question. Total scores for this measure range from 10 to 40. A higher score represents more frequent use of recommended weight-control behaviors for a max score of 40.

    Measured: baseline and 3 months 1 week

  6. Change in Eating Patterns

    This 10-item subscale is part of the Weight Control Assessment scale aim to measure food patterns as eating too much or in between meals. This scale asks participants to recall their behavior in the past 30 days. A Likert-scale: a)almost always, b)sometimes, c)rarely, and d)never, are provided for each question. Total scores for this measure range from 10 to 40. A higher score represents more frequent use of recommended weight-control behaviors for a max score of 40.

    Measured: baseline and 6 months 1 week

  7. Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)

    This 27 item assess physical activity and inactivity as reported by the participant over a variety of domains including at home, for work, leisure, and job-related. Both leisure moderate physical active days and average minutes per day were utilized to calculate total minutes across a week timespan.

    Measured: baseline and 3 months 1 week

  8. Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)

    This 27 item assess physical activity and inactivity as reported by the participant over a variety of domains including at home, for work, leisure, and job-related. Both leisure moderate physical active days and average minutes per day were utilized to calculate total minutes across a week timespan.

    Measured: baseline and 6 months 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start19 Apr 2023
  3. Primary completion1 Nov 2024
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856149
Sponsor's protocol ID
R44MD014082
Other IDs
R44MD014082
Status last verified
Feb 2026
First submitted
3 May 2023
Last updated
23 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Diabetes Prevention Program in people with Type 2 Diabetes, run by ISA Associates, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Change at Intervention Completion (time frame: baseline and 3 months 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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