Haas Marilyn C, Bodner Eric V, Brown Cynthia J, Bryan David, Buys David R, Keita Akilah Dulin, Flagg Lee Anne, Goss Amy, Gower Barbara, Hovater Martha, Hunter Gary, Ritchie Christine S, Roth David L, Wingo Brooks C, Ard Jamy, Locher Julie L
a Division of Gerontology, Geriatrics, and Palliative Care , University of Alabama at Birmingham , Birmingham , Alabama , USA.
J Nutr Gerontol Geriatr. 2014;33(4):376-400. doi: 10.1080/21551197.2014.965993.
We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.
我们开展了一项研究,旨在评估在一组社区居住的肥胖老年人中,有意减肥的益处是否超过潜在风险,这些老年人患心脏代谢疾病的风险增加。CROSSROADS试验采用前瞻性随机对照设计,比较单纯饮食成分改变或与减肥相结合的效果与仅进行运动的对照干预对身体成分和脂肪组织沉积(具体目标#1:比较单纯饮食成分改变或与减肥相结合的效果与仅进行运动的对照干预对身体成分,即内脏脂肪组织的影响)、心脏代谢疾病风险(具体目标#2:比较单纯饮食成分改变或与减肥相结合的效果与仅进行运动的对照干预对心脏代谢疾病风险的影响)以及功能状态和生活质量(具体目标#3:比较单纯饮食成分改变或与减肥相结合的效果与仅进行运动的对照干预对功能状态和生活质量的影响)的影响。参与者被随机分配到三组中的一组:仅运动(对照)干预、运动 + 饮食质量 + 体重维持干预或运动 + 饮食质量 + 减肥干预。CROSSROADS采用了一种包括运动、饮食和行为成分的生活方式干预方法。本文介绍了CROSSROADS方案的制定和实施,包括方法描述、生活方式干预具体要素的详细说明、治疗保真度保证和参与者保留情况;结果测量和不良事件监测;以及试验结果独特的数据管理特征。