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
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in glucose
研究概览
简要总结
This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. 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
- 否
入选标准
- •18-75 years of age
- •BMI of 27 kg/m2 or greater for ambulatory individuals and 22 kg/m2 for individuals with spinal cord injury. Adjustments will be calculated for those with amputations and/or limb indifference
- •at risk for developing type 2 diabetes (prediabetes)
- •One or more physical or mobility disabilities
- •Stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite
- •Willing to complete requirements for participation
排除标准
- •Pregnant, planning to become pregnant or breastfeeding
- •Currently taking medication(s) for weight loss
- •Medical history of Type 1 or 2 Diabetes, using exogenous insulin, using prescription or OTC weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)
研究组 & 干预措施
High Carbohydrate Diet
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.
干预措施: High Carbohydrate Diet (Behavioral)
Reduced Carbohydrate Diet
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.
干预措施: Reduced Carbohydrate Diet (Behavioral)
结局指标
主要结局
Change in glucose
时间窗: Baseline & Week 16
Serum glucose will be measured in a fasted state.
Changes in body weight
时间窗: Baseline, Week4, and Week 16
Measured on validated digital scale
次要结局
- Changes in fat mass(Baseline & Week 16)
- Change in insulin(Baseline & Week 16)
- Changes in lipids(Baseline & Week 16)
- Changes in QUICKI index(Baseline & Week 16)
- Changes in overall strength(Baseline & Week 16)
- Changes in aerobic fitness(Baseline & Week 16)
研究者
Christine Ferguson, PhD, RD, LD
Assistant Professor
University of Alabama at Birmingham