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

测试减肥手术后通过心理和行为干预促进身体活动的可行性和初步效果

• 批准号: 10442451
• 负责人: Emily Feig
• 金额: $ 19.19万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10442451
• 关键词: Accelerometer; Achievement; Address; Adherence; Affect; Area; Behavior Therapy; Behavioral; Biological Factors; Biometry; Blood Pressure; Body Weight decreased; Cardiometabolic Disease; Caring; Chronic Disease; Clinic; Clinical; Clinical Research; Clinical Trials; Custom; Disease; Eating Disorders; Emotional; Evidence based intervention; Exercise; Feedback; General Hospitals; Goals; Health; Health behavior; Health behavior change; Heart Diseases; Informal Social Control; Intervention; Intervention Studies; Intervention Trial; Interview; Journals; Lipids; Logistics; Maintenance; Massachusetts; Measurement; Measures; Medical; Medicine; Mental Depression; Mentors; Mentorship; Methods; Modeling; Morbid Obesity; Motivation; National Heart, Lung, and Blood Institute; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Operative Surgical Procedures; Outcome; Participant; Patients; Peer Review; Personal Satisfaction; Phase; Physical activity; Physiological; Pilot Projects; Population; Positioning Attribute; Procedures; Psychologist; Psychology; Public Health; Publications; Publishing; Qualitative Methods; Qualitative Research; Quality of life; Randomized Controlled Trials; Research; Research Personnel; Research Training; Resources; Surveys; Techniques; Testing; Training; United States National Institutes of Health; Walking; Weight; Weight Gain; Well in self; Work; acceptability and feasibility; arm; bariatric surgery; base; behavior change; cardiometabolic risk; career; comparison intervention; design; effective intervention; effective therapy; efficacy trial; exercise intervention; experience; feasibility testing; gratitude; high risk population; implementation research; improved; insulin sensitivity; meetings; mood regulation; motivational enhancement therapy; multidisciplinary; novel; novel diagnostics; novel strategies; novel therapeutic intervention; obese patients; optimism; performance tests; pilot trial; preference; prevent; programs; psychologic; psychological outcomes; recruit; remote delivery; symposium; telehealth; telephone delivery; therapy development; treatment as usual; trial comparing; waist circumference

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.

项目概要/摘要 候选人。这项 K23 提案将使 Feig 博士成为一名独立调查员，具有以下方面的专业知识： 开发和测试基于证据的干预措施，以改善肥胖患者的健康和福祉。 迄今为止，她所取得的成就证明了她作为临床研究员的承诺（20 篇出版物，20 演讲），并且通过额外的培训和指导，她将为减少 减轻肥胖负担并提高肥胖患者的生活质量。 指导。导师包括临床试验和健康行为改变方面的专家（霍夫曼博士和 桑代克）；定性研究（Psaros 博士）以及肥胖和减肥的医学和生物因素 手术（WLS；Kaplan 和 Thorndike 博士）。合作者 Healy 博士将提供生物统计学专业知识和 培训和顾问李博士将分享她在客观测量身体活动方面的专业知识。 培训计划。 Feig 博士将通过 (1) 定性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措施的试验； (3)生理学 与体力活动相关的健康指标。除了定期的指导会议和体验活动 通过研究计划的培训，她将完成课程作业，参加研讨会和国家研讨会并在会上发表演讲 会议，并在同行评审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。 WLS 是治疗严重肥胖症最有效的治疗方法，但约 25% 的患者会这样做 手术后无法实现持续有意义的体重减轻。坚持健康行为和 心理健康与手术后维持减肥有关。获得持续支持 由于定期就诊的后勤障碍，手术后的干预往往受到限制。无障碍 需要采取干预措施来提高 WLS 后陷入困境的患者的依从性。 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来适应和 测试远程医疗积极心理动机访谈（PP-MI）健康行为干预措施以改善 马萨诸塞州总医院 WLS 后患者的体力活动和心理健康状况 体重中心。第 1 阶段包括 (1) 对 WLS 后患者 (n=20) 进行定性访谈，以探讨需求和 干预偏好。第 2 阶段是新改编的 PP-MI 的小型单臂试点试验（n=10） 干预加退出访谈，进一步测试和完善干预内容和研究程序。第三阶段 将需要进行随机对照试验（n=50）来评估 PP-MI 的可行性和可接受性 与加强常规护理控制相比，干预对身体活动和心理健康的影响 24 周。该 K23 为 R01 在全面试验中评估疗效奠定了基础。