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临床试验/NCT05856149
NCT05856149已完成不适用

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

ISA Associates, Inc.1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2023年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
1
主要终点
Percent Weight Change at Intervention Completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older
  • Language fluency in English or Spanish
  • 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

排除标准

  • <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

研究组 & 干预措施

STEPS

Experimental

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.

干预措施: Mobile Diabetes Prevention Program (Behavioral)

Usual Care

No Intervention

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

结局指标

主要结局

Percent Weight Change at Intervention Completion

时间窗: 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

时间窗: 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.

次要结局

  • Change in Diabetes Knowledge Assessment(baseline and 6 months 1 week)
  • Change in Eating Patterns(baseline and 6 months 1 week)
  • Change in Hemoglobin A1C Levels(baseline and 3 months 1 week)
  • Change in Hemoglobin A1C Levels(baseline and 6 months 1 week)
  • Change in Diabetes Knowledge Assessment(baseline and 3 months 1 week)
  • Change in Eating Patterns(baseline and 3 months 1 week)
  • Change in Subjectively Measured LESIURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)(baseline and 3 months 1 week)
  • Change in Subjectively Measured LEISURE MODERATE Physical Activity - International Physical Activity Questionnaire (IPAQ)(baseline and 6 months 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Debra Rios

Research Scientist

ISA Associates, Inc.

研究点 (1)

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