Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Weight trajectory
研究概览
简要总结
This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
- •Age 18-65, inclusive
排除标准
- •Alcohol or substance use disorder in past year
- •Severe psychiatric disorder that may affect ability to complete the protocol
- •Regular tobacco use during the last year
- •Current medication taken routinely and known to impact factors that may affect the gut microbiome
- •Use of any oral or injectable antibiotic in the past month
- •Use of commercially available pre/pro biotic in the past month
- •History of significant disease/disorder that would be expected to impact the microbiome of the gut
- •Inability to engage in physical activity or dietary monitoring
- •Nonprescribed/illicit drug use
- •Pregnant or breastfeeding
结局指标
主要结局
Weight trajectory
时间窗: 24 months
Weight outcomes following bariatric surgery
次要结局
未报告次要终点
研究者
Kristine Steffen
Associate Professor
North Dakota State University