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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Diabetes Prevention Program |
| Usual Care | No intervention | Participants 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.
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
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)
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
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
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
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
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
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
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
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.
- First posted12 May 2023
- Study start19 Apr 2023
- Primary completion1 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ISA Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Debra Rios, ISA Associates, Inc.
- Investigators
- Debra M Rios, DrPH, Principal investigator, ISA Associates
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach
- ClinicalTrials.gov ID
- NCT05856149
- Acronym / sponsor ID
- R44MD014082
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- ISA Associates, Inc.University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Posted 23 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS | Experimental | Behavioral: Mobile Diabetes Prevention ProgramParticipants 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. |
| Usual Care | No intervention | –Participants in the Usual Care control group will not receive an intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older
- Language fluency in English or Spanish
- Hispanic
- High risk for prediabetes using the CDC's Prediabetic Screener
- Rural county residence
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Diabetes Prevention ProgramThe 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. | Behavioural | STEPS |
Primary outcome
Percent Weight Change at Intervention Completion
Time frame: baseline and 3 months 1 week
Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.
Percent Weight Change Three Months Post Intervention
Time frame: baseline and 6 months 1 week
Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.
8 secondary outcomes
Change in Hemoglobin A1C Levels
Time frame: baseline and 3 months 1 week
Change in Hemoglobin A1C Levels
Time frame: baseline and 6 months 1 week
Change in Diabetes Knowledge Assessment
Time frame: baseline and 3 months 1 week
Change in Diabetes Knowledge Assessment
Time frame: baseline and 6 months 1 week
Change in Eating Patterns
Time frame: baseline and 3 months 1 week
Change in Eating Patterns
Time frame: baseline and 6 months 1 week
Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
Time frame: baseline and 3 months 1 week
Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
Time frame: baseline and 6 months 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra M Rios, DrPH principal investigator
ISA Associates
1 site in 1 country: see every site and its status.
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.