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Mobile Diabetes Prevention for Hispanics Living in Rural Areas

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Diabetes Prevention Program
Sponsored by
ISA Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Community Action Corporation of South Texas Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEPS

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in body mass index
Participants height will be measured at baseline along with weight. Research staff will then use this information to calculate body mass index.
Change in body mass index
Participants height will be measured at baseline along with weight. Research staff will then use this information to calculate body mass index.
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.
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.
Change in Dietary behaviors - Hispanic Dietary Assessment
The 24-item measure has two portions that assess how often the individual eats a variety of foods and how many daily portions of fruits and vegetables are consumed. For the variety of food questions, a total fat score is calculate with a range of 0 to 34, with the lower number being healthier. For the fruit and vegetable consumption, a total consumption number is divided by seven to get an average daily rate.
Change in Dietary behaviors - Hispanic Dietary Assessment
The 24-item measure has two portions that assess how often the individual eats a variety of foods and how many daily portions of fruits and vegetables are consumed. For the variety of food questions, a total fat score is calculated with a range of 0 to 34, with the lower number being healthier. For the fruit and vegetable consumption, a total consumption number is divided by seven to get an average daily rate.
Change in Diabetes Knowledge Assessment
A 20-item measure will assess knowledge gained due to the intervention. The questions are answered using true or false indicators.
Change in Diabetes Knowledge Assessment
A 20-item measure will assess knowledge gained due to the intervention. The questions are answered using true or false indicators.
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. A Likert-scale from 'almost always' to 'never' is provided for each question.
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. A Likert-scale from 'almost always' to 'never' is provided for each question.
Change in Subjectively Measured 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. The time spent is used to then calculate MET minutes. MET minutes are the amount of energy expended during a minute while at rest.
Change in Subjectively Measured 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. The time spent is used to then calculate MET minutes. MET minutes are the amount of energy expended during a minute while at rest.
Change in Objectively Measured Physical Activity using Fitbits
Fitbits are provided to all participants and daily steps are gathered throughout the study. These steps will assess total objectively measured physical activity.
Change in Objectively Measured Physical Activity using Fitbits
Fitbits are provided to all participants and daily steps are gathered throughout the study. These steps will assess total objectively measured physical activity.
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
This 13-item measure assesses the individual's confidence level on a scale of 0-10, with 10 being 'completely confident' on a variety of health behaviors.
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
This 13-item measure assesses the individual's confidence level on a scale of 0-10, with 10 being 'completely confident' on a variety of health behaviors.
Stages of Change
This 2-item measure assesses an individual's current stage they see themselves in regard to healthy eating and physical activity. The responses range from 5- "Yes I have been for more than 6 months" (Maintenance) to 1 "No, and I do not intend to in the next 6 months"(Precontemplation).
Stages of Change
This 2-item measure assesses an individual's current stage they see themselves in regard to healthy eating and physical activity. The responses range from 5- "Yes I have been for more than 6 months" (Maintenance) to 1 "No, and I do not intend to in the next 6 months"(Precontemplation).
Change in Perceived Stress Scale
This 4-item measure assesses perceived stress from the past week. Responses range from 0- Never to 4- Very Often. Total scores range from 0-16 with higher scores indicating greater stress.
Change in Perceived Stress Scale
This 4-item measure assesses perceived stress from the past week. Responses range from 0- Never to 4- Very Often. Total scores range from 0-16 with higher scores indicating greater stress.
Change in Interpersonal Support Scale
This scale assesses support in the appraisal, belonging, and tangible support domains. Response scales range from 1- Definitely False to 4 - Definitely True. A total score and subscale scores are calculated with a lower number indicating less support.
Change in Interpersonal Support Scale
This scale assesses support in the appraisal, belonging, and tangible support domains. Response scales range from 1- Definitely False to 4 - Definitely True. A total score and subscale scores are calculated with a lower number indicating less support.
Change in Self-Reported Health
A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors.
Change in Self Reported Health
A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors.
Change in Diabetes Diagnosis
A single item will assess if an individual receives a medical diabetes diagnosis during the study.
Change in Diabetes Diagnosis
A single item will assess if an individual receives a medical diabetes diagnosis during the study.
Program Evaluation - Program Satisfaction
This 17-item measure will assess participant's satisfaction with the STEPS program.

Full Information

First Posted
May 3, 2023
Last Updated
May 11, 2023
Sponsor
ISA Associates, Inc.
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05856149
Brief Title
Mobile Diabetes Prevention for Hispanics Living in Rural Areas
Official Title
Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ISA Associates, Inc.
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEPS
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants in the Usual Care control group will not receive an intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Diabetes Prevention Program
Intervention Description
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 Outcome Measure Information:
Title
Percent weight change at intervention completion
Description
Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.
Time Frame
baseline and 3 months 1 week
Title
Percent weight change three months post intervention
Description
Weight will be assessed using a scale at study visits. Research staff will then use this number to calculate percent weight loss over time.
Time Frame
baseline and 6 months 1 week
Secondary Outcome Measure Information:
Title
Change in body mass index
Description
Participants height will be measured at baseline along with weight. Research staff will then use this information to calculate body mass index.
Time Frame
baseline and 3 months 1 week
Title
Change in body mass index
Description
Participants height will be measured at baseline along with weight. Research staff will then use this information to calculate body mass index.
Time Frame
baseline and 6 months 1 week
Title
Change in Hemoglobin A1C levels
Description
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.
Time Frame
baseline and 3 months 1 week
Title
Change in Hemoglobin A1C levels
Description
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.
Time Frame
baseline and 6 months 1 week
Title
Change in Dietary behaviors - Hispanic Dietary Assessment
Description
The 24-item measure has two portions that assess how often the individual eats a variety of foods and how many daily portions of fruits and vegetables are consumed. For the variety of food questions, a total fat score is calculate with a range of 0 to 34, with the lower number being healthier. For the fruit and vegetable consumption, a total consumption number is divided by seven to get an average daily rate.
Time Frame
baseline and 3 months 1 week
Title
Change in Dietary behaviors - Hispanic Dietary Assessment
Description
The 24-item measure has two portions that assess how often the individual eats a variety of foods and how many daily portions of fruits and vegetables are consumed. For the variety of food questions, a total fat score is calculated with a range of 0 to 34, with the lower number being healthier. For the fruit and vegetable consumption, a total consumption number is divided by seven to get an average daily rate.
Time Frame
baseline and 6 months 1 week
Title
Change in Diabetes Knowledge Assessment
Description
A 20-item measure will assess knowledge gained due to the intervention. The questions are answered using true or false indicators.
Time Frame
baseline and 3 months 1 week
Title
Change in Diabetes Knowledge Assessment
Description
A 20-item measure will assess knowledge gained due to the intervention. The questions are answered using true or false indicators.
Time Frame
baseline and 6 months 1 week
Title
Change in Eating Patterns
Description
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. A Likert-scale from 'almost always' to 'never' is provided for each question.
Time Frame
baseline and 3 months 1 week
Title
Change in Eating Patterns
Description
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. A Likert-scale from 'almost always' to 'never' is provided for each question.
Time Frame
baseline and 6 months 1 week
Title
Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
Description
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. The time spent is used to then calculate MET minutes. MET minutes are the amount of energy expended during a minute while at rest.
Time Frame
baseline and 3 months 1 week
Title
Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
Description
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. The time spent is used to then calculate MET minutes. MET minutes are the amount of energy expended during a minute while at rest.
Time Frame
baseline and 6 months 1 week
Title
Change in Objectively Measured Physical Activity using Fitbits
Description
Fitbits are provided to all participants and daily steps are gathered throughout the study. These steps will assess total objectively measured physical activity.
Time Frame
baseline and 3 months 1 week
Title
Change in Objectively Measured Physical Activity using Fitbits
Description
Fitbits are provided to all participants and daily steps are gathered throughout the study. These steps will assess total objectively measured physical activity.
Time Frame
baseline and 6 months 1 week
Title
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
Description
This 13-item measure assesses the individual's confidence level on a scale of 0-10, with 10 being 'completely confident' on a variety of health behaviors.
Time Frame
baseline and 3 months 1 week
Title
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
Description
This 13-item measure assesses the individual's confidence level on a scale of 0-10, with 10 being 'completely confident' on a variety of health behaviors.
Time Frame
baseline and 6 months 1 week
Title
Stages of Change
Description
This 2-item measure assesses an individual's current stage they see themselves in regard to healthy eating and physical activity. The responses range from 5- "Yes I have been for more than 6 months" (Maintenance) to 1 "No, and I do not intend to in the next 6 months"(Precontemplation).
Time Frame
baseline and 3 months 1 week
Title
Stages of Change
Description
This 2-item measure assesses an individual's current stage they see themselves in regard to healthy eating and physical activity. The responses range from 5- "Yes I have been for more than 6 months" (Maintenance) to 1 "No, and I do not intend to in the next 6 months"(Precontemplation).
Time Frame
baseline and 6 months 1 week
Title
Change in Perceived Stress Scale
Description
This 4-item measure assesses perceived stress from the past week. Responses range from 0- Never to 4- Very Often. Total scores range from 0-16 with higher scores indicating greater stress.
Time Frame
baseline and 3 months 1 week
Title
Change in Perceived Stress Scale
Description
This 4-item measure assesses perceived stress from the past week. Responses range from 0- Never to 4- Very Often. Total scores range from 0-16 with higher scores indicating greater stress.
Time Frame
baseline and 6 months 1 week
Title
Change in Interpersonal Support Scale
Description
This scale assesses support in the appraisal, belonging, and tangible support domains. Response scales range from 1- Definitely False to 4 - Definitely True. A total score and subscale scores are calculated with a lower number indicating less support.
Time Frame
baseline and 3 months 1 week
Title
Change in Interpersonal Support Scale
Description
This scale assesses support in the appraisal, belonging, and tangible support domains. Response scales range from 1- Definitely False to 4 - Definitely True. A total score and subscale scores are calculated with a lower number indicating less support.
Time Frame
baseline and 6 months 1 week
Title
Change in Self-Reported Health
Description
A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors.
Time Frame
baseline and 3 months 1 week
Title
Change in Self Reported Health
Description
A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors.
Time Frame
baseline and 6 months 1 week
Title
Change in Diabetes Diagnosis
Description
A single item will assess if an individual receives a medical diabetes diagnosis during the study.
Time Frame
baseline and 3 months 1 week
Title
Change in Diabetes Diagnosis
Description
A single item will assess if an individual receives a medical diabetes diagnosis during the study.
Time Frame
baseline and 6 months 1 week
Title
Program Evaluation - Program Satisfaction
Description
This 17-item measure will assess participant's satisfaction with the STEPS program.
Time Frame
3 months 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra M Rios, DrPH
Phone
7037390880
Ext
2
Email
drios@isagroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra M Rios, DrPH
Organizational Affiliation
ISA Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Action Corporation of South Texas Health Center
City
Alice
State/Province
Texas
ZIP/Postal Code
78332
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra M Rios, DrPH
Phone
703-739-0880
Ext
2
Email
drios@isagroup.com
First Name & Middle Initial & Last Name & Degree
DEBRA M RIOS, DrPH

12. IPD Sharing Statement

Learn more about this trial

Mobile Diabetes Prevention for Hispanics Living in Rural Areas

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