Clinical trial NCT05856149: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: ISA Associates, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-12
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percent weight change at intervention completion
timeFrame: baseline and 3 months 1 week
measure: Percent weight change three months post intervention
timeFrame: baseline and 6 months 1 week
Secondary outcomes:
measure: Change in body mass index
timeFrame: baseline and 3 months 1 week
measure: Change in body mass index
timeFrame: baseline and 6 months 1 week
measure: Change in Hemoglobin A1C levels
timeFrame: baseline and 3 months 1 week
measure: Change in Hemoglobin A1C levels
timeFrame: baseline and 6 months 1 week
measure: Change in Dietary behaviors - Hispanic Dietary Assessment
timeFrame: baseline and 3 months 1 week
measure: Change in Dietary behaviors - Hispanic Dietary Assessment
timeFrame: baseline and 6 months 1 week
measure: Change in Diabetes Knowledge Assessment
timeFrame: baseline and 3 months 1 week
measure: Change in Diabetes Knowledge Assessment
timeFrame: baseline and 6 months 1 week
measure: Change in Eating Patterns
timeFrame: baseline and 3 months 1 week
measure: Change in Eating Patterns
timeFrame: baseline and 6 months 1 week
measure: Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline and 3 months 1 week
measure: Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline and 6 months 1 week
measure: Change in Objectively Measured Physical Activity using Fitbits
timeFrame: baseline and 3 months 1 week
measure: Change in Objectively Measured Physical Activity using Fitbits
timeFrame: baseline and 6 months 1 week
measure: Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
timeFrame: baseline and 3 months 1 week
measure: Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
timeFrame: baseline and 6 months 1 week
measure: Stages of Change
timeFrame: baseline and 3 months 1 week
measure: Stages of Change
timeFrame: baseline and 6 months 1 week
measure: Change in Perceived Stress Scale
timeFrame: baseline and 3 months 1 week
measure: Change in Perceived Stress Scale
timeFrame: baseline and 6 months 1 week
measure: Change in Interpersonal Support Scale
timeFrame: baseline and 3 months 1 week
measure: Change in Interpersonal Support Scale
timeFrame: baseline and 6 months 1 week
measure: Change in Self-Reported Health
timeFrame: baseline and 3 months 1 week
measure: Change in Self Reported Health
timeFrame: baseline and 6 months 1 week
measure: Change in Diabetes Diagnosis
timeFrame: baseline and 3 months 1 week
measure: Change in Diabetes Diagnosis
timeFrame: baseline and 6 months 1 week
measure: Program Evaluation - Program Satisfaction
timeFrame: 3 months 1 week
Other outcomes:
Locations:
city: Alice
country: United States
facility: Community Action Corporation of South Texas Health Center
state: Texas
Study officials:
affiliation: ISA Associates
name: Debra M Rios, DrPH
role: PRINCIPAL_INVESTIGATOR
References: