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: 10673764
• 负责人: Emily Feig
• 金额: $ 18.65万
• 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/10673764
• 关键词: Accelerometer; Achievement; Address; Adherence; Affect; Area; Behavior Therapy; Behavioral; Biological Factors; Biometry; Blood Pressure; Body Weight decreased; Cardiometabolic Disease; Career Mobility; Caring; Chronic Disease; Clinic; Clinical; Clinical Research; Clinical Trials; 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; Recommendation; Research; Research Personnel; Resources; Risk Reduction; Surveys; Techniques; Testing; Training; United States National Institutes of Health; Walking; Weight; Weight Gain; Well in self; Work; acceptability and feasibility; arm; bariatric surgery; behavior change; comparison intervention; design; effective intervention; effective therapy; efficacy evaluation; efficacy trial; exercise intervention; experience; feasibility testing; gratitude; high risk population; implementation research; improved; insulin sensitivity; intervention refinement; 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; surgical risk; 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.

项目总结/摘要 候选人这项K23提案将使Feig博士成为一名独立的研究人员， 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。 她的成就，迄今证明了她的承诺，作为一个临床研究人员（20出版物，20 她将通过额外的培训和指导，为减少 减轻肥胖负担，提高肥胖患者的生活质量。 导师制。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专业知识， 李博士将与我们分享她在客观量度体力活动方面的专业知识。 培训计划。Feig博士将通过以下方面的研究和培训计划实现短期目标：（1）定性 研究;（2）设计和实施健康行为改变干预试验;（3）生理 与身体活动有关的健康措施。沿着定期的导师会议和体验 通过研究计划的培训，她将完成课程，参加并出席研讨会和国家 会议，并在同行评审的期刊上发表研究结果。培训计划还包括课程和 支持专门针对推进她作为独立调查员的职业生涯的计划。 背景WLS是治疗严重肥胖症最有效的方法，但大约25%的患者 手术后不能达到持续的有意义的体重减轻。既坚持健康行为， 心理健康与手术后体重减轻的维持有关。获得持续支持 并且手术后的干预通常由于常规诊所就诊的后勤障碍而受到限制。可访问 需要干预措施来改善WLS后患者的依从性。 研究战略。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，以改善 来自马萨诸塞州总医院的WLS术后患者的身体活动和心理健康 重量中心。第1阶段包括（1）对WLS后患者（n=20）进行定性访谈，以探索需求， 干预偏好。II期是一项新调整的PP-MI的小型单组初探性试验（n=10） 研究人员将通过干预加离职面谈的方式，进一步测试和完善干预内容和研究程序。3期 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 干预相比，加强日常护理控制身体活动和心理健康， 24周该K23为R 01在全面试验中评估疗效奠定了基础。