Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study

打破长时间久坐行为以改善心脏代谢健康：一项适应性剂量探索研究

基本信息

批准号：
10667379
负责人：
Ken Cheung
金额：
$ 76.38万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-05 至 2026-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10667379
关键词：
Address Adult Advisory Committees Advocate Affect American American Heart Association Behavioral trial Blood Glucose Blood Pressure Cardiovascular Diseases Cohort Studies Data Developed Countries Development Diastolic blood pressure Dose Effectiveness Elements Emotions Epidemic Exhibits Fatigue Foundations Frequencies Future Glucose Guidelines Health Health Benefit Hour Hypoglycemia Interruption Intervention Laboratories Link Maximum Tolerated Dose Measures Methods Moods Morbidity - disease rate Outcome Participant Performance Persons Phase Physical activity Process Protocols documentation Public Health Randomized Randomized, Controlled Trials Recommendation Reporting Research Risk Risk Factors Safety Smoking Standardization Strenuous Exercise Testing Time Visit Walking Work adverse outcome cardiometabolism cardiovascular disorder prevention cardiovascular disorder risk cardiovascular risk factor dose information energy balance evidence base evidence based guidelines exhaustion experimental study improved innovation mortality phrases psychological distress randomized trial recruit sedentary sedentary lifestyle success therapy development uptake vigorous intensity

项目摘要

Excessive sedentary behavior is highly prevalent in developed nations and is a risk factor for cardiovascular disease (CVD) morbidity and mortality. Evidence suggests sedentary behavior is not simply a form of inactivity that elicits positive energy balance. Instead sedentary behavior itself may be harmful. As such, health agencies have provided general recommendations to “sit less, move more” by interspersing brief periods of activity. However, a lack of empirical evidence describing how often (e.g. every 30 min, every 60 min) and for how long (e.g. 1 min activity bouts, 5 min activity bouts) sedentary time should be interrupted (a “sedentary break”) to yield health benefit has precluded more quantitative, actionable guidelines. To date, rigorous and methodical dose escalation experiments have not been conducted to elucidate efficacious and tolerated sedentary break doses. Without specific targets to provide to the public; public health initiatives targeting sedentary behavior will likely have minimal effectiveness. Critically, without rigorously tested dosing information; randomized controlled trials targeting sedentary behavior may be fruitless; bearing risk of inefficacious or intolerable doses. The objective of the proposed study is to determine the minimally effective dose (e.g. the smallest dose) for two elements of a sedentary break, frequency and duration, that yields improvements in established CVD risk factors. We will also determine the maximally tolerated dose (e.g. the highest dose that does not cause undue physical/psychological distress) for both frequency and duration of sedentary breaks. To address our aims, we will conduct a state-of-the-art dose finding study under well controlled laboratory conditions using an innovative Bayesian adaptive randomization method for dose determination never before applied to behavioral trials. This method will enable us to efficiently test 25 possible frequency/duration combinations in just a single study. We will recruit 324 adults to complete a total of 2 trial conditions in the laboratory (8 hours each), namely a sedentary break (active) condition and an uninterrupted sitting (control) condition, in a randomized order. The sedentary break condition will consist of 1 of 25 possible frequency/duration combinations (e.g. every 30 min for 10 min), selected according to the adaptive randomization protocol. Established CVD risk factors, including blood pressure and glucose, as well as measures of dose tolerability (physical exhaustion/fatigue, affect) and work engagement and performance will be serially assessed during each trial. We view this project as a groundbreaking step towards developing evidence-based guidelines for sedentary behavior that will establish a foundation upon which a successful sedentary behavior intervention development process can be rooted. By identifying the minimally effective and maximally tolerated dose combinations for the frequency and duration of a sedentary break; this study will provide key foundational evidence critical to the success of future Phase III and Phase IV randomized trials and ultimately public health guidelines.

在发达国家中过度久坐行为非常普遍，是心血管的危险因素疾病（CVD）发病率和死亡率。有证据表明久坐行为不仅仅是一种不活动的形式这引起了积极的能量平衡。相反，久坐行为本身可能是有害的。因此，卫生机构通过散布短暂的活动时，提供了一般建议，以“少坐，移动更多”。但是，缺乏经验证据，描述了多久（例如每30分钟，每60分钟一次）以及多长时间（例如，1分钟的活动回合，5分钟的活动回合）久坐时间应中断（“久坐的断裂”）收益健康的益处已排除了更定量，可行的指南。迄今为止，严格而有条不紊尚未进行剂量升级实验以阐明有效且久经内的破裂剂量。没有具体的目标来向公众提供；针对久坐行为的公共卫生计划将可能的有效性很小。至关重要的是，没有严格测试的给药信息；随机控制针对久坐行为的试验可能毫无结果。具有无效或肠剂量的风险。这拟议的研究的目的是确定两个的最小有效剂量（例如，最小剂量）久坐的断裂，频率和持续时间的元素可以改善已建立的CVD风险因素。我们还将确定最大耐受剂量（例如，不会引起撤消的最高剂量身体/心理困扰）在久坐的频率和持续时间内。为了解决我们的目标，我们将使用创新的实验室条件下进行最先进的剂量研究研究贝叶斯自适应随机化方法用于确定剂量的确定，以前从未应用于行为试验。这方法将使我们仅在一项研究中有效地测试25种可能的频率/持续时间组合。我们将招募324名成年人，以完成实验室中总共2个试验条件（每个小时），即久坐的断裂（活动）条件和不间断的坐姿（控制）条件，以随机顺序。这久坐的断裂状况将包括25个可能的频率/持续时间组合中的1个（例如每30分钟一次根据自适应随机化协议选择10分钟）。建立的CVD风险因素，包括血压和葡萄糖以及剂量耐受性（身体疲劳/疲劳，影响）和每次试验期间，将对工作参与和绩效进行连续评估。我们将这个项目视为一个开创性的步骤朝着制定基于证据的久坐行为准则，这将建立一个可以植根成功的久坐行为干预发展过程的基础。经过确定在频率和持续时间的最低有效和最大耐受剂量组合久坐的休息；这项研究将为未来III阶段成功至关重要的关键基础证据和IV期随机试验以及最终公共卫生指南。