PASO A PASO Pilot Study: Tailored Diabetes Prevention Program for Spanish-Speaking Communities Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Weight percent change
研究概览
简要总结
The interdisciplinary and interprofessional community-academic partnership (CAP) has been working with Spanish-speaking H/L Salt Lake City residents and organization leaders to adapt the National Diabetes Prevention Program to meet the needs of this population. This next collaboration phase attempts to finalize the adapted diabetes prevention program, "Paso a Paso," and evaluate its feasibility and implementation strategies. The purpose of this pilot study is to inform the necessary modifications to the Paso a Paso diabetes prevention intervention, ensuring that the full-scale future intervention is both feasible and effective for the target community.
详细描述
Specific goals include:
- Finalize the adapted "Paso a Paso" protocol and materials.
- Train the first cohort of instructors for the program (10-15 potential instructors)
- Test the feasibility of the intervention implementation with 30 community participants.
- Gather feedback from participants, refine the intervention, and ensure that it resonates with community members, ultimately laying the foundation for a successful larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native Spanish speakers, residents in the Wasatch Front Metropolitan area, adults aged >18 years old with a BMI of ≥ 25, and diabetes risk >1 based on the CDC Prediabetes Risk Test
排除标准
- •Bariatric surgery in the last 2 years or planned during the next year
- •Edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
- •Current or planned pregnancy in the next year
- •Current breastfeeding
研究组 & 干预措施
Community-based organizations leaders and community members
Paso a Paso is a 12-month program designed for H/L community members who are at high risk for T2D and want to lower their risk.
干预措施: Paso a Paso (Behavioral)
结局指标
主要结局
Weight percent change
时间窗: Baseline, 4-month, 12-month (exploratory)
Will be measured in kilograms using a calibrated Tanita WB-100A scale.
次要结局
- % HbA1c(Baseline, 4-month, 12-month (exploratory))
研究者
Margaret (Molly) B. Conroy
Professor and Chief, Division of General Internal Medicine
University of Utah