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临床试验/NCT07316569
NCT07316569已完成不适用

Healthy Eating and Active Living to Reverse Diabetes Pilot Study

University of Tennessee2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in Hemoglobin A1c (HbA1c)

研究概览

简要总结

The HEAL Diabetes Program is a multicomponent intensive plant-forward healthy eating program designed to reverse diabetes. Several recent studies, most notably the Diabetes UK-funded Diabetes Remission Clinical Trial (DiRECT) in England and Scotland, have demonstrated that intensive programs for weight loss and weight loss maintenance can lead to long-term remission of diabetes for as many as half of patients with early Type 2 (adult-onset) diabetes. Furthermore, the U.S. Preventive Services Task Force has recommended that all patients with obesity and at highest risk for diabetes be referred to such intensive multicomponent behavioral weight loss interventions, but no such programs are available for people living in the low-income and underserved areas of Memphis. This effort will pilot an innovative, culturally tailored, and intensive healthy eating program designed to reverse diabetes based in the UTHSC Neighborhood Health Hub located in low-income neighborhoods to demonstrate that this approach will work in Memphis to improve and extend people's lives. The HEAL Diabetes Pilot Program will: a) engage and retain a minimum of 30 patients with Type 2 diabetes and obesity to participate in the program as well as 30 additional "control" patients who will receive routine care, and b) assess patient outcomes including weight loss and rates of diabetes remission using average blood sugar (hemoglobin A1c) over a six-month period. The healthy eating and active living to reverse diabetes (HEAL Diabetes) is a pilot study that aims to evaluate the feasibility, effectiveness, and operational and financial sustainability of a multicomponent health coach-supported nutrition intervention in a predominately African American population in Memphis, Tennessee. The investigators aim to assess study feasibility by evaluating recruitment, sample characteristics, intervention acceptability and procedural suitability. The investigators also aim to quantify and compare the treatment and control groups on primary outcomes including changes in body weight, hemoglobin A1c (HbA1c), and proportion of patients who achieved diabetes remission (HbA1c25 < 6.5%) from baseline to 12-months. Additionally, the investigators aim to assess changes in diabetes self-efficacy and self-care activities and examine cost effectiveness of the multicomponent intervention. Drawing on evidence from DiRECT, MODEL, and related studies, the investigators hypothesize that the intervention arm will achieve greater weight loss and higher diabetes remission than the control. Additionally, the investigators hypothesize that the program will be operationally and financially sustainable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • Patients must meet the following criteria to be eligible:
  • adults 18 years or older
  • a type 2 diabetes (T2D) duration of 0-6 years (diagnosis based on one recorded HbA1c test)
  • HbA1c value ≥ 6.5 percent at the screening visit
  • BMI ≥ 25 kg/m2
  • access to a cell phone or smartphone with texting and voicemail capabilities

排除标准

  • current use of insulin or more than two hypoglycemic medications (either oral or injectable)
  • a recent routine HbA1c greater than or equal to 12%
  • weight loss of >5 kg within the last six months
  • inability to understand consent procedures, understand and speak English
  • pregnancy or considering pregnancy
  • diagnosis or exhibited unstable psychiatric condition, dementia, neurological disorder, or history of severe head trauma or brain tumor, and cognitive impairment
  • perceived unwillingness or inability to participate
  • planned move from the region during the study
  • participation in another clinical research trial.

结局指标

主要结局

Change in Hemoglobin A1c (HbA1c)

时间窗: Baseline to 6 months

Change in HbA1c (%) from baseline to 6 months

Change in Body Weight

时间窗: From enrollment to the end of 6 months.

Change in body weight in pounds from baseline to 6 months

Proportion of Participants Achieving Diabetes Remission

时间窗: 6 months

Proportion of participants achieving diabetes remission at 6 months, defined as HbA1c \< 6.5% without use of glucose-lowering medications for at least 2 months

次要结局

  • Change in Random Blood Glucose(Baseline to 6 months)
  • Change in Diabetes Self-Efficacy Score(Baseline to 6 months)
  • Change in Diabetes Self-Care Activities Score(Baseline to 6 months)
  • Cost of Intervention Delivery(6 months)

研究者

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

James E. Bailey, MD, MPH

Executive Director, Tennessee Population Health Consortium

University of Tennessee

研究点 (2)

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