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NCT Number: NCT05856149

Mobile Diabetes Prevention for Hispanics Living in Rural Areas

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Action Corporation of South Texas Health Center

Alice, Texas, 78332, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • <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

Treatment and study plan

Mobile Diabetes Prevention Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Hemoglobin A1C Levels

    Time frame: baseline and 3 months 1 week

    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.

  2. Change in Hemoglobin A1C Levels

    Time frame: baseline and 6 months 1 week

    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.

  3. Change in Diabetes Knowledge Assessment

    Time frame: baseline and 3 months 1 week

    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.

  4. Change in Diabetes Knowledge Assessment

    Time frame: baseline and 6 months 1 week

    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.

  5. Change in Eating Patterns

    Time frame: baseline and 3 months 1 week

    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.

  6. Change in Eating Patterns

    Time frame: baseline and 6 months 1 week

    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.

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

    Time frame: baseline and 3 months 1 week

    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.

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

    Time frame: baseline and 6 months 1 week

    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.

Sponsors and collaborators

Lead sponsor

ISA Associates, Inc.

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 12, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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