Swift Damon L, McGee Joshua E, Huff Anna C, Clunan Marie C, Gniewek Nicole R, Brown Taylor T, Osborne Briceida G, Bucher Colleen, Tanner Charles J, Barefoot Savanna G, Brophy Patricia, Clark Angela, Dubis Gabriel S, Martin Corby K, Beyl Robbie A, Houmard Joseph A, Carels Robert A, Pories Walter, Matarese Laura E
Department of Kinesiology, East Carolina University, Greenville, NC, 27858, USA.
Human Performance Laboratory, East Carolina Univeristy, Greenville, NC, 27858, USA.
Contemp Clin Trials Commun. 2021 Jan 20;21:100717. doi: 10.1016/j.conctc.2021.100717. eCollection 2021 Mar.
Clinically significant weight loss is associated with health benefits for overweight and obese adults. Participation in adequate amounts of physical activity is critical for weight maintenance. However, the recommended amount of physical activity needed to promote weight maintenance is based primarily on retrospective studies that quantified physical activity levels through questionnaires which tend to overestimate physical activity levels. In addition, the present literature has provided little data on the impact of these physical activity levels on cardiovascular and diabetes risk factors, which may have equal or more clinical importance than weight changes. The Prescribed Exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss in overweight and obese adults (BMI 25-40 kg/m) age 30-65 years. Participants (N = 39) will complete a 10-week OPTIFAST® weight loss program with supervised aerobic exercise training. Individuals who achieve ≥7% weight loss from baseline will be subsequently randomized to levels of aerobic training consistent with physical activity recommendations (PA-REC) or weight maintenance recommendations (WM-REC) for 18 additional weeks. The primary outcome of the PREVAIL-P study will be change in weight from the completion of OPTIFAST® program to the end of the study. Notable secondary measures include changes in clinically relevant cardiometabolic risk factors between study groups (e.g. blood lipids concentrations, oral glucose tolerance, arterial stiffness). This pilot study will be used to estimate the effect sizes needed for a randomized controlled trial on this topic.
临床上显著的体重减轻对超重和肥胖成年人的健康有益。参与适量的体育活动对维持体重至关重要。然而，促进体重维持所需的推荐体育活动量主要基于回顾性研究，这些研究通过问卷调查来量化体育活动水平，而问卷调查往往会高估体育活动水平。此外，目前的文献几乎没有提供关于这些体育活动水平对心血管和糖尿病风险因素影响的数据，而这些因素可能比体重变化具有同等或更大的临床重要性。减肥后减少复发的规定运动 - 试点（PREVAIL - P）研究将评估有氧运动训练量对30至65岁超重和肥胖成年人（BMI 25 - 40 kg/m²）在临床上显著减重后体重维持的影响。参与者（N = 39）将完成一个为期10周的OPTIFAST®减肥计划，并接受有监督的有氧运动训练。从基线体重减轻≥7%的个体随后将被随机分配到与体育活动建议（PA - REC）或体重维持建议（WM - REC）一致的有氧运动训练水平，再持续18周。PREVAIL - P研究的主要结果将是从完成OPTIFAST®计划到研究结束时的体重变化。值得注意的次要测量指标包括研究组之间临床相关的心脏代谢风险因素的变化（例如血脂浓度、口服葡萄糖耐量、动脉僵硬度）。这项试点研究将用于估计关于该主题的随机对照试验所需的效应大小。
