Trial Outcomes & Findings for Mobile Diabetes Prevention for Hispanics Living in Rural Areas (NCT NCT05856149)

NCT ID: NCT05856149

Last Updated: 2026-02-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

179 participants

Primary outcome timeframe

baseline and 3 months 1 week

Results posted on

2026-02-23

Participant Flow

Participants were recruited through a federally qualified health center in South Texas. They were provided flyers to reach out to research staff if interested. If interested, they were screened for eligibility. Once eligible, participants were scheduled for their baseline appointment.

Of the 288 potential participants screened, 179 were eligible and randomized.

Participant milestones

Participant milestones
Measure
STEPS Intervention
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
Control condition participants will receive usual care with no additional education.
Overall Study
STARTED
90
89
Overall Study
COMPLETED
70
76
Overall Study
NOT COMPLETED
20
13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobile Diabetes Prevention for Hispanics Living in Rural Areas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
STEPS Intervention
n=90 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=89 Participants
Control condition participants will receive usual care with no additional education.
Total
n=179 Participants
Total of all reporting groups
Age, Continuous
47.77 years
STANDARD_DEVIATION 13.59 • n=58 Participants
50.63 years
STANDARD_DEVIATION 15.30
49.18 years
STANDARD_DEVIATION 14.49 • n=1 Participants
Sex: Female, Male
Female
70 Participants
n=58 Participants
65 Participants
135 Participants
n=1 Participants
Sex: Female, Male
Male
20 Participants
n=58 Participants
24 Participants
44 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
90 Participants
n=58 Participants
89 Participants
179 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Weight
208.1 pounds
STANDARD_DEVIATION 53.9 • n=58 Participants
192.8 pounds
STANDARD_DEVIATION 58.6
200.5 pounds
STANDARD_DEVIATION 56.7 • n=1 Participants

PRIMARY outcome

Timeframe: baseline and 3 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=70 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=71 Participants
Control condition participants will receive usual care with no additional education.
Percent Weight Change at Intervention Completion
-.14 Mean percent change
Standard Deviation 4.1
2.3 Mean percent change
Standard Deviation 11.9

PRIMARY outcome

Timeframe: baseline and 6 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=70 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=76 Participants
Control condition participants will receive usual care with no additional education.
Percent Weight Change Three Months Post Intervention
-.50 Mean percent change
Standard Deviation 4.8
-.12 Mean percent change
Standard Deviation 5.7

SECONDARY outcome

Timeframe: baseline and 3 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=59 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=65 Participants
Control condition participants will receive usual care with no additional education.
Change in Hemoglobin A1C Levels
A1C 3 MONTHS 1 WEEK POST
5.6 Percentage of Glycated Hemoglobin
Standard Deviation .64
5. Percentage of Glycated Hemoglobin
Standard Deviation .74
Change in Hemoglobin A1C Levels
A1C Baseline
5.7 Percentage of Glycated Hemoglobin
Standard Deviation .82
5.8 Percentage of Glycated Hemoglobin
Standard Deviation .95

SECONDARY outcome

Timeframe: baseline and 6 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=63 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=71 Participants
Control condition participants will receive usual care with no additional education.
Change in Hemoglobin A1C Levels
Baseline a1c
5.7 Percentage of Glycated Hemoglobin
Standard Deviation .82
5.8 Percentage of Glycated Hemoglobin
Standard Deviation .96
Change in Hemoglobin A1C Levels
6 months 1 week post A1C
5.5 Percentage of Glycated Hemoglobin
Standard Deviation .80
5.5 Percentage of Glycated Hemoglobin
Standard Deviation .45

SECONDARY outcome

Timeframe: baseline and 3 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=49 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=47 Participants
Control condition participants will receive usual care with no additional education.
Change in Diabetes Knowledge Assessment
Baseline Knowledge
17.4 Total score
Standard Deviation 2.1
17.6 Total score
Standard Deviation 1.9
Change in Diabetes Knowledge Assessment
3 months 1 week post knowledge
17.6 Total score
Standard Deviation 2.2
17.7 Total score
Standard Deviation 1.8

SECONDARY outcome

Timeframe: baseline and 6 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=48 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=49 Participants
Control condition participants will receive usual care with no additional education.
Change in Diabetes Knowledge Assessment
Baseline Knowledge
17.6 Total score
Standard Deviation 2.2
17.6 Total score
Standard Deviation 1.9
Change in Diabetes Knowledge Assessment
6 Months 1 week post knowledge
17.1 Total score
Standard Deviation 2.3
17.5 Total score
Standard Deviation 2.2

SECONDARY outcome

Timeframe: baseline and 3 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=35 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=39 Participants
Control condition participants will receive usual care with no additional education.
Change in Eating Patterns
Baseline Eating Pattern Total Score
25.2 Total score
Standard Deviation 4.9
24.2 Total score
Standard Deviation 4.4
Change in Eating Patterns
3 months 1 week post Eating Pattern Total Score
24.8 Total score
Standard Deviation 4.1
24.6 Total score
Standard Deviation 4.2

SECONDARY outcome

Timeframe: baseline and 6 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=33 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=39 Participants
Control condition participants will receive usual care with no additional education.
Change in Eating Patterns
Baseline eating patterns score
24.6 Total score
Standard Deviation 4.7
24.2 Total score
Standard Deviation 4.4
Change in Eating Patterns
6 months 1 week post eating patterns score
24.7 Total score
Standard Deviation 4.4
24.7 Total score
Standard Deviation 4.3

SECONDARY outcome

Timeframe: baseline and 3 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=60 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=58 Participants
Control condition participants will receive usual care with no additional education.
Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
Baseline Leisure Moderate Physical Activity
33.7 Total minutes
Standard Deviation 126.7
87.1 Total minutes
Standard Deviation 201.2
Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
3months 1 week Leisure Moderate Physical Activity
74.8 Total minutes
Standard Deviation 383.6
157.2 Total minutes
Standard Deviation 683.8

SECONDARY outcome

Timeframe: baseline and 6 months 1 week

Population: Due to missing data and/or "prefer not to answer" option within the study surveys and procedures (i.e., weight assessment and A1C measurement), the total number of participants analyzed for this outcome is less than the N=179.

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.

Outcome measures

Outcome measures
Measure
STEPS Intervention
n=59 Participants
Experimental Group participants will have access to the STEPS intervention. STEPS- Small Steps to Diabetes Prevention: A web-based, mobile diabetes prevention program for rural Hispanics. This tailored, mobile diabetes prevention program aims to reduce diabetes risk among Hispanics living in rural communities through an evidence-based, theoretically informed tailored intervention. Potential users will be guided through 12 modules that provide tailored diabetes prevention education and skill building to reduce diabetes risk. Additionally, STEPS includes a variety of important features and tools including SMS text messages, goal setting, a steps counter, and a way to connect with social support. We envision this intervention being used by clinics and community based organizations that serve Hispanics living in rural areas.
Control
n=57 Participants
Control condition participants will receive usual care with no additional education.
Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
Baseline leisure moderate physical activity
34.1 total minutes
Standard Deviation 127.7
84.7 total minutes
Standard Deviation 202.3
Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)
6 months 1 week post leisure moderate physical activity
21.0 total minutes
Standard Deviation 52.7
177.8 total minutes
Standard Deviation 717.4

Adverse Events

STEPS Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debra Rios

ISA Associates, Inc.

Phone: 7037390462

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place