Development and Pilot Testing of an Adaptive Intervention to Prevent Weight Regain Following Weight Loss in Adults with Overweight and Obesity

项目摘要/摘要 这是卫生署助理教授Tanya Halliday博士的K01奖项申请书 和犹他大学健康学院的运动学。哈利迪博士正在确立自己作为一个 肥胖研究领域的新兴领导者，特别是在开发有效的减肥维持干预措施方面。 这一K01奖项将为韩礼德博士提供必要的支持，以实现以下目标：1)加强 具备定性研究和混合方法的技能；2)发展复杂临床试验的专业知识 设计，特别是适应性干预和具有纵向后续行动的智能设计；以及3)制定 具有先进的研究领导力和管理技能。 为了实现这些目标，哈利迪博士组建了一个由两名联合小学导师组成的辅导团队。 莫莉·康罗伊博士，一位在执行大规模健康行为随机对照试验方面经验丰富的内科科学家，包括 减肥维持的研究，以及朱莉·弗里茨博士，临床和翻译科学家，在使用 适应性干预，一种研究设计，将被开发和测试，以防止体重在 建议的K01和智能设计。Halliday博士还将在定性研究方法和 苏珊·齐克蒙德博士的分析，沈金成博士担任自适应设计的生物静力学顾问 审判。 缺乏成功的长期减肥干预措施是肥胖管理面临的最大挑战。 根据最近的证据和她自己的初步数据，Halliday博士的中心假设是一种适应性 干预将是可行的，并能够在专业支持下进行个人定制的重新参与 防止故意减肥后体重回升。她将通过开发和试验来检验这一假设 对最近显著减少的成年人进行测试和为期6个月的适应性重新参与干预(≥7%) 体重与生活方式(饮食/运动)干预。通过追求以下具体目标，申请人 将验证她的假设并为临床试验收集数据，以1)定性地探索体重恢复的触发因素 体重减轻的成年人以及基于证据的适应性重新参与干预的优先方面； 2)开发一种适应性干预措施，在患者面临体重回升的风险时重新参与其中；以及3) 确定适应性再投入干预的可行性，以防止体重回升。 这项拟议的研究意义重大，因为减肥干预是不成功的长期和新的 预防体重回升的方法是必要的。拟议的研究具有创新性，因为自适应重新 参与度试验尚未作为减肥维持方法进行评估；适应性干预措施 通常不会像本项目中建议的那样通过严格的前期工作进行开发；以及成果衡量标准 将在6个月后进行评估，以确定适应性干预的纵向可行性 以防止体重回升。

PROJECT SUMMARY/ABSTRACT This is an application for a K01 award for Dr. Tanya Halliday, an Assistant Professor in the Department of Health & Kinesiology in the College of Health at the University of Utah. Dr. Halliday is establishing herself as an emerging leader in obesity research, specifically in developing efficacious weight loss maintenance interventions. This K01 award will provide Dr. Halliday the support necessary to accomplish the following goals: 1) Strengthen skills in qualitative research and mixed methods approaches; 2) Develop expertise in complex clinical trial design, particularly adaptive interventions and SMART designs with longitudinal follow-up; and 3) Develop advanced research leadership and management skills. To achieve these goals, Dr. Halliday has assembled a mentoring team comprised of a two Co-Primary Mentors. Dr. Molly Conroy, a physician-scientist experienced in performing large-scale health behavior RCTs, including studies of weight loss maintenance, and Dr. Julie Fritz, clinical and translational scientist with expertise in utilizing adaptive interventions, a type of study design which will be developed and tested to prevent weight regain in the proposed K01, and SMART designs. Dr. Halliday will also be mentored in qualitative research methods and analysis by Dr. Susan Zickmund, with Dr. Jincheng Shen serving as an advisor for biostatics for adaptive design trials. The lack of successful long-term weight loss interventions is the greatest challenge for obesity management. Based on recent evidence, and her own preliminary data, Dr. Halliday’s central hypothesis is that an adaptive intervention involving individually tailored re-engagement with professional support will be feasible and able to prevent weight regain following intentional weight loss. She will test this hypothesis by developing and pilot testing and 6-month adaptive re-engagement intervention in adults whom have recently lost a significant (≥7%) amount of weight with lifestyle (diet/exercise) interventions. By pursuing the following specific aims, the applicant will test her hypothesis and gather data for a clinical trial to 1) Qualitatively explore weight regain triggers for weight-reduced adults as well as preferred aspects of an evidence-based adaptive re-engagement intervention; 2) Develop an adaptive intervention to re-engage patients at times they are at risk of weight-regain; and 3) Determine the feasibility of an adaptive re-engagement intervention to prevent weight regain. The proposed research is significant because weight loss interventions are unsuccessful long-term and new approaches to prevent weight regain are needed. The proposed research is innovative because adaptive re- engagement trials have not been evaluated as a weight loss maintenance approach; adaptive interventions are typically not developed with rigorous preliminary work like that proposed in this project; and outcome measures will be evaluated after 6-months of follow-up to determine the longitudinal feasibility of the adaptive intervention to prevent weight regain.