Department of Health Behavior, University of Alabama at Birmingham (UAB), Birmingham, AL, USA.
O'Neal Comprehensive Cancer Center, UAB, Birmingham, AL, USA.
BMC Cancer. 2022 Apr 29;22(1):471. doi: 10.1186/s12885-022-09519-y.
Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project.
Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis.
Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors.
ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.
需要可扩展的、多行为改变干预措施来解决越来越多癌症幸存者中不良饮食、缺乏运动和超重的问题。经过疗效测试的饮食（RENEW）和运动（BEAT Cancer）计划已被改编为网络版，供中年和老年癌症幸存者使用，这是一项由美国国立癌症研究所资助的、多地点的项目计划。
在美国大陆，几种与肥胖相关的癌症幸存者正在被招募参加三项相互关联的随机对照试验（RCT）。项目 1 和 2 测试 6 个月的饮食或运动干预与等待名单对照条件。在 6 个月的研究期结束后，干预组参与者接受下一个行为改变序列（即，饮食接受运动，运动接受饮食），等待名单对照组开始进行 12 个月的联合饮食和运动干预。项目 3 测试顺序与同时干预的效果。评估在基线和半年度进行，最长可达 2 年，包括：体重指数、健康行为（饮食质量、加速度计评估的体力活动/睡眠）、腰围、D3 肌氨酸评估的肌肉量、身体表现、治疗效果的潜在中介/调节因素、炎症和代谢调节的生物标志物、卫生保健利用、成本和整体健康状况。四个共享资源支持 AMPLIFI RCT：1）行政；2）适应、传播和实施；3）招募和保留；4）评估和分析。
作为新一代 RCT，AMPLIFI 将专门使用远程技术招募、干预和评估新改编的基于网络的饮食和运动干预措施的效果，并确定顺序或联合提供方式是否最适合高危（老年、农村、少数族裔）癌症幸存者。
ClinicalTrials.gov，NCT04000880。注册于 2019 年 6 月 27 日。
