Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain

减肥手术后体重恢复的远程行为干预的评估

基本信息

批准号：
10735424
负责人：
Lauren E Bradley
金额：
$ 69.25万
依托单位：
TEMPLE UNIV OF THE COMMONWEALTH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10735424
关键词：
Address Adherence Aftercare Bariatrics Behavior Control Behavior Therapy Behavioral Biological Markers Body Weight Body Weight decreased Caring Cellular Phone Clinical Treatment Control Groups Diabetes Mellitus Eating Eating Behavior Ecological momentary assessment Educational process of instructing Elements Energy Intake Enrollment Evaluation Frequencies Gastrectomy Gastric Bypass Health Health Benefit Hunger Hypertension Individual Instruction Interruption Intervention Life Style Modification Measures Mediating Medical Morbid Obesity Operative Surgical Procedures Outcome Participant Patients Pattern Persons Physical activity Physiological Postoperative Care Postoperative Period Procedures Randomized Recommendation Recurrence Reporting Research Risk Telephone Testing Time Treatment Efficacy Weight Weight maintenance regimen Work active method bariatric surgery behavior test clinically significant comorbidity comparison control comparison intervention craving design dietary effective therapy efficacy evaluation efficacy testing experience follow-up food craving improved innovation mindfulness negative affect novel novel strategies obesity treatment online delivery online version patient engagement patient population pilot trial post intervention programs remote delivery response secondary outcome skills theories weight maintenance

项目摘要

PROJECT SUMMARY/ABSTRACT The proposed study is designed to evaluate the efficacy of a remotely-delivered, acceptance-based behavioral intervention (ABTi) for individuals demonstrating weight regain after bariatric surgery by comparing it to a Control condition. The current study aims to: 1) evaluate ABTi's efficacy on weight outcomes compared to Control; 2) evaluate ABTi's efficacy on secondary outcomes including improvements in eating behaviors, physical activity, and medical conditions compared to Control; 3) test proposed mechanisms of action, including evaluating a) if changes in hypothesized active ingredients in ABTi mediate differences in weight outcomes between conditions and b) if the association between eating behavior and subjective internal states (i.e., hunger, cravings, urges, negative affect) will weaken in ABTi compared to Control. Patients 6 to 48 months out from surgery who have regained >5% of their weight will be randomized to ABTi or Control (n=200). Assessments willbe conducted at baseline, 3, 6 (end of active treatment), and 12 months (follow up) after enrollment. Developing innovative interventions to reverse postoperative weight regain is crucial to maintain the health benefits of surgery in this growing population of patients not experiencing optimal postoperative results.

项目概要/摘要拟议的研究旨在评估远程交付、基于验收的效果通过比较减肥手术后体重恢复的个体的行为干预（ABTi）将其设置为控制条件。当前研究的目的是： 1) 评估 ABTi 对体重结果的功效控制； 2) 评估 ABTi 对次要结果的功效，包括饮食行为的改善，与对照相比，体力活动和医疗状况； 3）测试所提出的作用机制，包括评估 a) ABTi 中假设的活性成分的变化是否会介导体重差异条件和b）之间的结果是否饮食行为与主观内部状态之间的关联与对照组相比，ABTi 中的饥饿感（即饥饿、渴望、冲动、负面情绪）会减弱。患者 6 至 48 手术后几个月，体重恢复超过 5% 的患者将被随机分配至 ABTi 或对照组（n=200）。评估将在基线、第 3 个月、第 6 个月（积极治疗结束）和 12 个月（随访）时进行入学后。开发创新干预措施来扭转术后体重反弹对于在不断增长的未获得最佳体验的患者群体中保持手术的健康益处术后结果。