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临床试验/NCT04745572
NCT04745572已完成不适用

Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5月14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
90
试验地点
2
主要终点
Changes in body weight

研究概览

简要总结

This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years of age
  • BMI of 27 kg/m2 or greater
  • at risk for developing type 2 diabetes (prediabetes)

排除标准

  • Pregnant, planning to become pregnant, or breastfeeding
  • uncontrolled hypo or hyperthyroidism

结局指标

主要结局

Changes in body weight

时间窗: week 16 visit

Measured on digital scale at final visit.

次要结局

  • Change in glucose(week 16 visit)
  • Change in hemoglobin A1c(week 16 visit)
  • Change in insulin(week 16 visit)
  • Changes in QUICKI index(week 16 visit)

研究者

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

Holly Wyatt

Professor

University of Alabama at Birmingham

研究点 (2)

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