Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention

确定先天性心脏病体力活动生活方式干预的功效

• 批准号: 10709643
• 负责人: Jamie Jackson
• 金额: $ 63.01万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709643
• 关键词: Accelerometer; Address; Adolescence; Adolescent and Young Adult; Adult; Affective; Age; Aging; Attitude; Behavior; Behavior Therapy; Behavioral Mechanisms; Biological Markers; Cardiopulmonary; Cardiovascular system; Childhood; Chronic; Clinical; Complex; Congenital Abnormality; Control Groups; Coronary Arteriosclerosis; Effectiveness of Interventions; Elements; Exercise stress test; Family; Fostering; Frequencies; Gender; Goals; Happiness; Health; Health Care Costs; Hypertension; Intervention; Life Style; Measures; Metabolic; Modality; Monitor; Morbidity - disease rate; Outcome; Outcome Study; Participant; Phase; Physical activity; Physiology; Planning Theory; Population; Process; Randomized; Research; Risk; Schedule; Self Efficacy; Site; Survivors; Techniques; Time; Videoconferencing; aged; arm; attentional control; cardiorespiratory fitness; cardiovascular health; cardiovascular risk factor; comorbidity; comparison control; congenital heart disorder; cost effectiveness; design; efficacy evaluation; efficacy trial; exercise intervention; exercise prescription; expectation; family support; fitbit; follow-up; health assessment; improved; intervention effect; lifestyle intervention; moderate-to-vigorous physical activity; optimism; post intervention; secondary outcome; social norm; survivorship; theories; young adult

PROJECT SUMMARY/ABSTRACT As congenital heart disease (CHD) survivors enter adulthood, they have a greater risk for developing acquired cardiovascular complications (e.g., hypertension and coronary artery disease). These comorbidities are amenable to lifestyle changes, such as increasing physical activity, yet adolescence and young adulthood are when physical activity rates begin declining. The CHD Physical Activity Lifestyle intervention (CHD-PAL) targets transition-age CHD survivors, using an engaging face-to-face videoconferencing format that this theory- informed and tailored to the unique physiology and activity needs of each participant. The CHD-PAL videoconferencing sessions address elements of the Theory of Planned Behavior (TPB; i.e., attitudes, subjective norms, and perceived control for engaging in a behavior) and implements self-monitoring and goal- setting techniques. The CHD-PAL feasibility/preliminary efficacy trials indicated that CHD-PAL is feasible for AYAs and that CHD-PAL increases time spent in moderate-to-vigorous physical activity (MVPA) as compared to the control group for AYAs who engage in lower levels of physical activity. However, a larger trial is needed to determine the impact of CHD-PAL on MVPA, purported mechanisms (i.e., elements of TPB), and health outcomes among AYAs with CHD. The primary objective of the current study is to determine the impact of CHD-PAL on change in MVPA among 144 AYAs (ages 15-25) with moderate and complex forms of CHD who will be randomized to 1 of 2 arms: CHD-PAL or attention control (Control). CHD-PAL consists of a 20-week videoconferencing-administered physical activity intervention (9, 20- to 30-minute sessions; Fitbit® to self- monitor and set goals) with an interventionist (“coach”). Control participants will receive the same number and frequency of contacts with a coach using the same modality to discuss using the Fitbit without addressing the TPB hypothesized mechanisms or being directed to self-monitor or set goals. The primary study outcome is change in MVPA as measured by an accelerometer. Change in the TPB hypothesized mechanisms will be assessed as secondary outcomes and change in cardiorespiratory fitness (i.e., peak VO2 and METs) will be explored. Our specific aims are to (1) determine the impact of CHD-PAL on change in MVPA and examine effect durability, (2) explore change in the TPB mechanisms and their relevance to change MVPA, and (3) explore the impact of CHD-PAL on change in cardiorespiratory fitness. The current study is the next step in an iterative process to refine CHD-PAL before multisite assessment of longer-term health implications and cost effectiveness of the intervention for AYAs with CHD in a clinical setting. Ultimately, this research has the potential to improve cardiovascular outcomes for transition-aged CHD survivors, an understudied growing population in need, as well as other pediatric chronic conditions with cardiopulmonary risk.

项目总结/摘要 随着先天性心脏病（CHD）幸存者进入成年，他们患后天性心脏病的风险更大。 心血管并发症（例如，高血压和冠状动脉疾病）。这些合并症是 适应生活方式的改变，如增加身体活动，但青春期和青年期， 当身体活动率开始下降时。CHD体力活动生活方式干预（CHD-PAL） 目标是过渡年龄的冠心病幸存者，使用一种引人入胜的面对面视频会议形式，这种理论- 了解并根据每个参与者的独特生理和活动需求量身定制。CHD-PAL 视频会议会话处理计划行为理论（TPB;即，态度， 主观规范和对参与行为的感知控制），并实施自我监控和目标- 设置技术。CHD-PAL可行性/初步疗效试验表明，CHD-PAL用于 AYAs和CHD-PAL增加了中度至剧烈体力活动（MVPA）的时间， 与对照组相比，AYAs从事较低水平的体力活动。然而，需要进行更大规模的试验 为了确定CHD-PAL对MVPA的影响，声称的机制（即，和卫生 AYAs与CHD之间的结果。本研究的主要目的是确定 CHD-PAL在144名患有中度和复杂形式CHD的AYA（15-25岁）中的MVPA变化， 将被随机分配至2组之一：CHD-PAL或注意力控制（对照）。CHD-PAL包括20周的 视频会议管理的身体活动干预（9，20- 30分钟的会议; Fitbit®自我， 监督和设定目标）与干预者（“教练”）。对照组参与者将收到相同的号码， 使用相同模式与教练联系的频率，以讨论使用Fitbit，而不解决 TPB假设机制或被引导自我监控或设定目标。主要研究结果是 通过加速度计测量的MVPA的变化。城规会假设机制的改变， 评估为次要结果和心肺适应性的变化（即，峰值VO 2和MET） 探讨了我们的具体目标是（1）确定CHD-PAL对MVPA变化的影响，并检查 影响持久性，（2）探索TPB机制的变化及其与MVPA变化的相关性，以及（3） 探索CHD-PAL对心肺适应性变化的影响。目前的研究是一项 在对长期健康影响和成本进行多点评估之前改进CHD-PAL的迭代过程 在临床环境中对患有CHD的AYA进行干预的有效性。最终，这项研究 改善过渡年龄CHD幸存者心血管结局的潜力， 有需要的人群，以及其他具有心肺风险的儿科慢性疾病。