Lifestyle Empowerment for Alzheimer’s Prevention Prescribed by Physicians: Methods and Adaptations to COVID-19

Abstract The health care system is insufficiently capitalizing on the benefits of physical exercise in America’s aging population. Few tools exist to help clinicians incorporate physical activity into their clinical care, while barriers limit older adults from initiating and maintaining exercise programs. The Lifestyle Empowerment for Alzheimer’s Prevention (LEAP! Rx) Program has been designed to support providers and participants in lifestyle change. LEAP! Rx uses two forms of participant enrollment: physician referrals through electronic health records and self-referrals to test the efficacy of delivering a community-based exercise and healthy lifestyle program to older adults. After referral into the program, participants are randomized to receive the LEAP! Rx Program or are placed in a standard-of-care group to receive the program later. The LEAP! Rx program consists of a personalized and structured exercise program, lifestyle education, and mobile health monitoring. This includes a 12-week Empowerment phase with coaching and supervised exercise training, followed by a 40-week Lifestyle phase with intermittent supervised exercise and coaching. Lifestyle education includes monthly, evidence-based classes on optimal aging. The evaluation of LEAP! Rx focuses on 1) the assessment of implementation and scalability of the LEAP!Rx Program for clinicians and patients 2) the effect of the LEAP! Rx Program on cardiorespiratory fitness, 3) the impact of the LEAP! Rx Program on secondary intervention outcome measures of chronic disease risk factors, including insulin resistance, body composition, and lipids. If successful, this study’s findings could advance future healthcare practices, providing a new and practical approach to aging and chronic disease prevention. Competing Interest Statement The authors have declared no competing interest. Funding Statement This project was funded by the National Institute on Aging R01AG052954-01. Additional support was provided by P30 AG072973, the Clinical Translation Science Unit (UL1 TR002366), The Ann and Gary Dickinson Family Charitable Foundation, John and Marny Sherman, Brad and Libby Bergman, and GAP. T32 AG078114 supports Dr. Key. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This is a protocol manuscript. No human subjects data is reported. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes The abstract and body of the manuscript have been updated. Data Availability This is a protocol manuscript. No human subjects data is reported. Abbreviations - LEAP! Rx Program - Lifestyle Empowerment for Alzheimer’s Prevention - EHR - Electronic Health Record - m-Health - mobile-health - AD - Alzheimer’s Disease - KU ADRC - University of Kansas Alzheimer’s Disease Research Center - IPAQ - International Physical Activity Questionnaire - 6MWT - 6-Minute Walk Test - DEXA - dual-energy X-ray absorptiometry - HR-QOL - Health-related quality of life