Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALMobile Diabetes Prevention Program
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.
Sponsors
ISA Associates, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change at Intervention Completion | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1C Levels | 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. |
| Change in Diabetes Knowledge Assessment | 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. |
| Change in Eating Patterns | 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. |
| Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ) | 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. |
| Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDebra M Rios, DrPH
ISA Associates
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 288 potential participants screened, 179 were eligible and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.63 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 200.5 pounds STANDARD_DEVIATION 56.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 89 |
| other Total, other adverse events | 0 / 90 | 0 / 89 |
| serious Total, serious adverse events | 0 / 90 | 0 / 89 |
Outcome results
None listed