Testing the feasibility and preliminary efficacy of a psychological and behavioral intervention to promote physical activity after weight loss surgery

项目摘要/摘要 候选人。这份K23提案将使Feig博士成为一名具有以下专业知识的独立调查员 开发和测试循证干预措施，以改善肥胖患者的健康和幸福感。 到目前为止，她的成就证明了她作为一名临床研究人员的潜力(20种出版物，20种 演讲)，通过额外的培训和指导，她将为减少 减轻肥胖者的负担，提高肥胖者的生活质量。 师徒关系。导师包括临床试验和健康行为改变方面的专家(赫夫曼博士和 定性研究(Psaros博士)，以及肥胖和减肥的医学和生物因素 外科(WLS；卡普兰和桑代克医生)。合作者希利博士将提供生物统计学专业知识和 李博士将分享她在客观体力活动测量方面的专业知识。 培训计划。Feig博士将通过(1)定性的研究和培训计划实现短期目标 研究；(2)设计和实施健康行为改变干预试验；以及(3)生理学 与体力活动有关的健康指标。以及定期的导师会议和体验 通过研究计划进行培训，她将完成课程作业，参加研讨会并在国家 会议，并在同行评议的期刊上发表研究结果。培训计划还包括课程和 专门针对推进她作为独立调查员的职业生涯的支持计划。 背景资料。WLS是治疗严重肥胖症的最有效的治疗方法，但约有25%的患者这样做 手术后没有达到持续的有意义的减肥效果。对健康行为的坚持和对 心理健康与手术后的减肥保持有关。获得持续支持 由于常规诊所就诊的后勤障碍，手术后的干预通常是有限的。可及 需要干预措施来提高WLS后挣扎患者的依从性。 研究策略。为了解决这一差距，拟议的研究采用了混合方法设计，以适应和 测试远程健康积极心理-动机访谈(PP-MI)健康行为干预以改进 马萨诸塞州总医院WLS术后患者的体力活动和心理健康状况 体重中心。第一阶段包括(1)对WLS后患者(n=20)进行定性访谈，以探索需求和 干预首选项。第二阶段是新改装的PP-MI的小型单臂飞行员试验(n=10) 干预加上离职访谈，以进一步测试和细化干预内容和研究程序。第三阶段 将需要一项随机对照试验(n=50)来评估PP-MI的可行性和可接受性 干预与加强对身体活动和心理健康的日常护理控制的比较结束 24周。这款K23为R01在全面试验中评估疗效奠定了基础。

PROJECT SUMMARY/ABSTRACT Candidate. This K23 proposal will position Dr. Feig to become an independent investigator with expertise in developing and testing evidence-based interventions to improve health and well-being in patients with obesity. Her achievements thus far demonstrate her promise as a clinical researcher (20 publications, 20 presentations), and with additional training and mentorship she will significantly contribute to efforts to reduce the burden of obesity and improve quality of life for those with obesity. Mentorship. Mentors include experts in clinical trials and health behavior change (Drs. Huffman and Thorndike); qualitative research (Dr. Psaros), and medical and biological factors in obesity and weight-loss surgery (WLS; Drs. Kaplan and Thorndike). Collaborator Dr. Healy will provide biostatistical expertise and training, and consultant Dr. Lee will share her expertise in objective measurement of physical activity. Training Plan. Dr. Feig will achieve short-term goals through a research and training plan in (1) qualitative research; (2) designing and implementing trials for health behavior change interventions; and (3) physiological measures of health related to physical activity. Along with regular mentorship meetings and experiential training through the research plan, she will complete coursework, attend and present at seminars and national conferences, and publish findings in peer-reviewed journals. The training plan also includes courses and support programs specifically targeted at advancing her career as an independent investigator. Background. WLS is the most effective treatment available for severe obesity, yet about 25% of patients do not achieve sustained meaningful weight loss after surgery. Both adherence to health behaviors and psychological well-being are associated with weight loss maintenance after surgery. Access to ongoing support and intervention after surgery is often limited due to logistical barriers to regular clinic attendance. Accessible interventions are needed to improve adherence in post-WLS patients who are struggling. Research Strategy. To address this gap, the proposed study employs a mixed methods design to adapt and test a telehealth positive psychology-motivational interviewing (PP-MI) health behavior intervention to improve physical activity and psychological well-being in post-WLS patients from the Massachusetts General Hospital Weight Center. Phase 1 includes (1) qualitative interviews with post-WLS patients (n=20) to explore needs and intervention preferences. Phase 2 is a small single-arm pilot trial (n=10) of the newly adapted PP-MI intervention plus exit interviews, to further test and refine intervention content and study procedures. Phase 3 will entail a randomized controlled trial (n=50) to assess the feasibility and acceptability of the PP-MI intervention compared to an enhanced usual care control on physical activity and psychological well-being over 24 weeks. This K23 lays the groundwork for an R01 to assess efficacy in a full-scale trial.