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临床试验/NCT04616482
NCT04616482Unknown不适用

Supporting and Enabling Physicians to Deliver Personalized Therapeutic Nutrition Using an Online Technology Platform

University of British Columbia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The percentage of eligible patients who receive prescriptions to access the online TCR program

研究概览

简要总结

Low-carbohydrate diets (less than approximately 130 grams per day) are emerging as an efficacious treatment option with several studies supporting weight loss and remission of type 2 diabetes. Many physicians are now implementing this strategy but the time it takes to educate patients on nutrition is a barrier. The research team is working with physicians to develop a solution whereby the nutrition education and intervention is delivered via mobile/online technology (i.e., an app). This study will test whether it is feasible and efficacious for physicians to recommend this app to their patients with obesity and type 2 diabetes to help them lose weight and improve their condition.

详细描述

The study is a non-experimental feasibility study to explore the acceptability, practicality and demand for the use of a 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction for individuals with obesity and/or at risk for type 2 diabetes/with type 2 diabetes. The program is intended to enhance the usual clinical care provided for patients with these conditions and will allow for physicians to monitor patient progress through the program. Both physician and patient perspectives will be explored.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Overweight or obese (BMI >25 kg/m2)
  • At risk for T2D as deemed by physician
  • Diagnosed with T2D
  • Able to read and speak English (in order to communicate with the technology platform/app
  • Over the age of 18

排除标准

  • Unable to read or speak English (due to the app being provided in English)
  • Unable to access a computer or mobile phone that has access to the internet.
  • Currently compliant with a very low carbohydrate ketogenic diet or very low calorie commercial weight loss program
  • Planning to change doctors in the next 12 months.

结局指标

主要结局

The percentage of eligible patients who receive prescriptions to access the online TCR program

时间窗: through study completion, an average of 9 months

Assessed through the number of voucher cards handed-out over physician documentation of eligible patient visits over the study period.

次要结局

  • Present descriptive characteristics of patients who get prescriptions to access the online TCR program(through study completion, an average of 9 months)
  • The percentage of patients who receive a prescription for TCR program that sign up and start(through study completion, an average of 9 months)
  • Program drop-out as assessed by the number of patients who sign up for and start the TCR program and the number of patients who complete the full program.(Pre-program (month 0) to post-program (6 months))
  • Program impact assessed through changes in weight from pre-program to post-program.(Pre-program (month 0) to post-program (6 months))
  • Program impact assessed through change in HbA1c from pre-program to post-program.(Pre-program (month 0) to post-program (6 months))
  • Program impact assessed through changes in medications from pre-program to post-program.(Pre-program (month 0) to post-program (6 months))

研究者

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

Jonathan Little

Associate Professor

University of British Columbia

研究点 (1)

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