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临床试验/NCT05640869
NCT05640869进行中(未招募)不适用

The Diabetes Prevention Program to Treat Overweight and Obesity

Auburn University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Change in A1c

研究概览

简要总结

The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community pharmacy setting. The long-term goal is to demonstrate the potential to improve diabetes prevention efforts through expanded access to weight loss services provided in community pharmacies.

详细描述

An estimated 38% percent of U.S. adults currently has prediabetes. In individuals aged 65 years and older, the prevalence of prediabetes is 48.8%. Prediabetes is commonly a precursor to the development of type 2 diabetes (t2d). Approximately 5-10% of individuals with prediabetes progress to t2d annually, with 70% developing t2d within their lifetime. Obesity is a significant risk factor for both prediabetes and diabetes, and its prevalence is steadily increasing. In 2020, a combined 66.7% of U.S. adults were classified as overweight or obese. In individuals with prediabetes, interventions leading to a 5-10% decrease in baseline body weight decrease the risk for progression to t2d by 58% at three years and 71% for those aged 60 years and older. At ten and fifteen years, the risk was decreased by 34% and 27%, respectively, and diabetes progression was significantly delayed. Based on these findings, a structured lifestyle intervention program was developed and has been available for public use by the Centers for Disease Control and Prevention (CDC) since 2010. Despite significant resources for the implementation of the Diabetes Prevention Program (DPP), program dissemination and utilization remains low. There are currently 1,882 registered DPP providers nationwide. Due to the modest results attributed to significant efforts to increase the access to and participation in DPP programs across the country, consideration should be given to modifying the current approach to diabetes prevention efforts.

In 2020, approximately 42.4% of American adults had obesity according to the 2021 State of Obesity: Better Policies for a Healthier America report. The prevalence of obesity has been steadily increasing for the last two decades. This upward trend is expected to continue this if effective and sustainable solutions are not employed. According to the CDC, in 2013-2016, 49.1% of adults reported having tried to lose weight within the last year. Searching "weight loss" in any internet browser will return over a billion results ranging from diet plans and weight loss programs to testimonials of individual weight loss journeys. Due to the prevalence of overweight and obesity, the demand for weight loss interventions, and the efficacy of weight reduction for decreasing the risk for t2d development, expanding access to evidence-based weight loss interventions has the potential to significantly advance diabetes prevention efforts nationwide by shifting the focus from preventing prediabetes to treating overweight and obesity. One major gap in the current treatment landscape is how to implement an effective program for adult weight loss with widespread impact.

Given the prevalence and visibility of community pharmacies, this setting is ideal for the dissemination of weight management services. In order to assess the potential impact, this pilot study aims to implement a modified-DPP program and to assess the diabetes risk and health outcomes of individuals choosing to participate in the program..

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • ≥18 years old
  • BMI ≥ 25kg/m2 (23 if Asian)

排除标准

  • Pregnancy

结局指标

主要结局

Change in A1c

时间窗: 3- and 6- months

Change from baseline A1c

Weight loss

时间窗: 6 months

Change from baseline body weight

次要结局

  • Proportion of patients meeting DPP program criteria(From enrollment, assessed once enrollment is complete, within 3 months of study start.)
  • Blood pressure change(6 months)
  • Physical activity change(6 months)

研究者

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

Courtney E Gamston

Professor of Experiential Practice

Auburn University

研究点 (2)

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