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Planning Grant for an Intensive Weight Loss Clinical Trial for Overweight and Obese Patients Post Total Knee Replacement

为全膝关节置换术后超重和肥胖患者进行强化减肥临床试验规划拨款

基本信息

批准号：
9767027
负责人：
WILLIAM M MIHALKO
金额：
$ 20.06万
依托单位：
UNIVERSITY OF TENNESSEE HEALTH SCI CTR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2021-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9767027
关键词：
Address Adult Affect Area Behavior Therapy Behavioral Blood Pressure Body Weight decreased Caring Clinic Clinical Practice Guideline Clinical Trials Data Databases Development Diabetes Mellitus Diet Disease Education Effectiveness Enrollment Epidemic Expenditure Focus Groups Funding Future Grant Health Health Care Sector Health Personnel Health Sciences Heart Diseases High Prevalence Hypertension Individual Institutional Review Boards Intervention Interview Knee Knee Osteoarthritis Limb structure Link Literature Manuals Medical Mining Modification Monitor Moods NIH Program Announcements National Heart, Lung, and Blood Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases Obesity Operative Surgical Procedures Orthopedics Outcome Outcome Assessment Overweight Patient Recruitments Patients Physical activity Physicians Population Population Replacements Populations at Risk Prevalence Private Sector Production Protocols documentation Public Sector Quality of life Randomized Clinical Trials Research Project Grants Risk Risk Factors Safety Societies Statistical Data Interpretation Surveys Technology Tennessee Testing Translating Underserved Population United States United States National Institutes of Health Universities Weight Weight Gain base comparison group economic impact formative assessment functional improvement good diet group intervention health economics high risk improved informant instrument knee replacement arthroplasty lifestyle intervention operation patient population primary outcome prospective protocol development recruit response secondary outcome standard of care weight loss intervention weight loss program

项目摘要

This proposal is in response to the NIH Program Announcement PAR16-446 titled “NIAMS Clinical Trial Planning Grant (R34).” It is well known that obesity has been linked to many medical issues such as hypertension, diabetes and heart disease, as well as to early knee osteoarthritis. Large clinical trials, such as Look AHEAD (Action for Health in Diabetes), have shown that multicomponent weight loss interventions combining diet, physical activity, and behavioral modification are the most effective in achieving long-term weight loss (1, 2). As a result, clinical practice guidelines recommend the delivery of obesity interventions for numerous health conditions. The prevalence of the total knee replacement (TKR) surgical procedure has increased exponentially in the United States over the last few decades and overweight and obese patients are at particularly high risk of needing a TKR during their lifetime (3-5). A more alarming fact is that once an overweight or obese patient has undergone TKR, they are less likely to lose weight and are more likely to gain additional weight post-surgery. Unfortunately, with increases in BMI comes decreases in functionality of the TKR and greater likelihood of need for future revision of the current TKR in addition to need for TKR of the opposite limb (6). This unfortunate paradigm presents an accumulating disparity for the overweight and obese TKR patient population. Despite this ever-growing disparity, a void in the current literature examining the efficacy of long term weight loss in overweight and obese individuals who have undergone TKR persists. Therefore, it remains unknown if a multicomponent weight loss intervention would be beneficial to the subset of the overweight and obese population who have undergone TKR. To address this disparity, we propose a clinical trial planning grant to translate the successful Look AHEAD intensive lifestyle intervention (ILI) for use in overweight and obese post TKR patients, and to plan a future study to test whether the Look AHEAD ILI will result in significant weight loss in this at-risk population. We further propose to test whether these weight loss changes translate into functional improvements in the overweight and obese post TKR patient population compared to those receiving standard of care support and education alone. The planning grant will be conducted in 2 stages: a formative assessment stage (stage 1) and a, U01, clinical trial development stage (stage 2). During stage 1 we will modify the successful Look AHEAD ILI to be applied to the specific needs of the overweight and obese TKR patient population. During stage 2 we will outline the specific ILI modifications, develop the appropriate statistical analyses, and finalize our protocols utilizing information gathered via focus groups and key informant interviews to inform development the U01 clinical trial application. Given the epidemic proportion of overweight and obese patients requiring TKR surgery, we believe the health and economic impact of this study will be immeasurable.

本提案是对NIH项目公告PAR16-446题为“NIAMS临床试验”的回应