The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.
Primary Aims.
- To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
- To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).
Exploratory Aim.
(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.
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
- None
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
- •Has undergone any type of weight loss surgery at least 1.5 years ago
- •Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.
- •Ability to give consent and speak, write, and understand English.
排除标准
- •Currently enrolled in structured weight loss program
- •Currently pregnant/plan to become pregnant within 6 months of enrollment
- •Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen
- •Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality
- •Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening
- •Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents
研究组 & 干预措施
Wait List Control
The Wait-List Control (WLC) condition does not receive any intervention during the study period. They receive the intervention after completing the study.
Treatment
Ten weekly modules will be delivered through an e-learning platform (i.e., Coursesites). Each module includes a video presentation of material synchronized with a slideshow illustrating session material with interactive features, and directed assignments to be completed throughout the week. At the end of every two weeks, a brief (i.e., 20 min) telephone call with a member of the study team will be scheduled to discuss and clarify the content of the session, discuss how the participant utilized skills demonstrated in the session, problem-solve difficulties in utilizing the skills, and review homework. Participants will be required to weigh themselves weekly (data will be transferred wirelessly to the laboratory) and feedback regarding weight losses will be provided during the phone call. The interventionist will provide individualized feedback on food records via email.
干预措施: Acceptance Based Behavioral Intervention (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 10 weeks
次要结局
- Repetitive Eating Assessment-Questionnaire (Rep(eat))(10 weeks)
- Paffenbarger Physical Activity Recall(10 weeks)
- Loss of Control Eating Scale (LOCES)(10 weeks)
- Food-Related Acceptance and Action Questionnaire (FAAQ)(10 weeks)
- Emotional Eating Scale (EES)(10 weeks)
- The Eating Inventory(10 weeks)
- Philadelphia Mindfulness Scale (PHLMS)(10 weeks)
- Drexel Defusion Scale (DDS)(10 weeks)
研究者
Lauren Bradley
Assistant Professor
Rush University Medical Center