Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
The purpose of the study is to conduct a randomized clinical trial examining the feasibility and effectiveness of two guided self-help behavioral weight loss (gshBWL) treatments delivered via the internet for individuals struggling with weight loss one year following bariatric surgery. The two treatments will consist of 1) gshBWL delivered through the internet only (gshBWL-I) and 2) gshBWL delivered via the internet with additional complementary phone sessions (gshBWL-IP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric bypass and sleeve surgery patients from Yale's Bariatric/Gastrointestinal Surgery Program
- •surgery 1-2 years prior
- •<60% excess weight loss
- •able to read English proficiently enough to read the patient self-help materials and study assessments
- •available for the duration of the treatment
- •availability of internet and phone to participate in study interventions
- •agree to the study procedures
排除标准
- •medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
- •unable to ambulate
- •current medications that influence eating/weight
- •current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment.
研究组 & 干预措施
Internet
Guided self-help behavioral weight loss treatment delivered via the internet
干预措施: Guided Self-Help Behavioral Weight Loss (Behavioral)
Internet Plus Phone
Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations
干预措施: Guided Self-Help Behavioral Weight Loss (Behavioral)
结局指标
主要结局
Weight Change
时间窗: 3 months
Percent weight loss (in pounds) from baseline.
次要结局
未报告次要终点