Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
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
- 是
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
Holly Wyatt
Professor
University of Alabama at Birmingham
