Type 2 Diabetes Clinical Trial
Official title:
Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach
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.
Status | Recruiting |
Enrollment | 165 |
Est. completion date | March 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Community Action Corporation of South Texas Health Center | Alice | Texas |
Lead Sponsor | Collaborator |
---|---|
ISA Associates, Inc. | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline and 3 months 1 week | |
Primary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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). | baseline and 3 months 1 week | |
Secondary | 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). | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | 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. | baseline and 3 months 1 week | |
Secondary | 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. | baseline and 6 months 1 week | |
Secondary | Change in Self-Reported Health | A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors. | baseline and 3 months 1 week | |
Secondary | Change in Self Reported Health | A 2-item measure assesses self-rated health (1-excellent to 5-poor) and future intentions for health behaviors. | baseline and 6 months 1 week | |
Secondary | Change in Diabetes Diagnosis | A single item will assess if an individual receives a medical diabetes diagnosis during the study. | baseline and 3 months 1 week | |
Secondary | Change in Diabetes Diagnosis | A single item will assess if an individual receives a medical diabetes diagnosis during the study. | baseline and 6 months 1 week | |
Secondary | Program Evaluation - Program Satisfaction | This 17-item measure will assess participant's satisfaction with the STEPS program. | 3 months 1 week |
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