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.

项目摘要/摘要 随着先天性心脏病（CHD）的生存进入成年，他们有更大的发展风险 心血管并发症（例如，高血压和冠状动脉疾病）。这些合并症是 适合生活方式的改变，例如增加体育锻炼，但是青少年和成年年轻人是 当体育锻炼率开始下降时。 CHD体育锻炼生活方式干预（CHD-PAL） 采用引人入胜的面对面视频会议格式的过渡时代冠心病生存。 根据每个参与的独特生理和活动需求，知情并量身定制。冠心病 视频会议会议介绍计划行为理论的要素（TPB；即吸引， 主观规范，并认为控制行为的控制）并实现自我监控和目标 - 设置技术。 CHD-PAL的可行性/初步有效性试验表明，CHD-PAL是可行的 AYA和CHD-PAL增加了在现代到凶猛的体育锻炼（MVPA）上花费的时间 向对照组的AYA进行较低的体育活动。但是，需要更大的试验 为了确定CHD-PAL对MVPA的影响，声称的机制（即TPB元素）和健康 与CHD的AYA中的结果。当前研究的主要目的是确定 关于144个AYA（15-25岁）中MVPA变化的CHD-PAL具有中等和复杂形式的CHD 将被随机分为2个臂中的1个：冠心pal或注意力控制（控制）。 CHD-PAL由20周组成 视频会议管理的体育锻炼干预（9，20至30分钟的会话；Fitbit®到自我 用干预主义者（“教练”）监视和设定目标）。控制参与者将获得相同的数字，并且 与教练的接触频率使用相同的方式使用Fitbit讨论而无需解决 TPB假设的机制或被指向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更改。 TPB假设机制的变化将是 评估为次要结果和心肺适应性的变化（即VO2和Mets） 探索。我们的具体目的是（1）确定CHD-PAL对MVPA变化的影响并检查 效应耐用性，（2）探索TPB机制的变化及其与更改MVPA的相关性，以及（3） 探索冠心病对心肺适应性变化的影响。当前的研究是下一步 在多站点评估长期健康影响和成本之前，要精炼冠心病的迭代过程 在临床环境中对AYA的干预措施的有效性。最终，这项研究具有 改善过渡时期冠心病生存的心血管结局的潜力，这是一种理解 有需要的人群以及其他患有心肺风险的小儿慢性病。