Goodwin Ashley M, Gordon Samantha, Sahni Ravneet, Vicari Frank, Accardi Kaitlyn, Crusco Salvatore, Duer-Hefele Joan, Friel Ciaran, Suls Jerry, Cheung Ying Kuen, Vrany Elizabeth A, Davidson Karina W
Northwell Health, New Hyde Park, New York, USA
Feinstein Institutes for Medical Research, New Hyde Park, New York, USA.
BMJ Open. 2025 Jan 4;15(1):e080307. doi: 10.1136/bmjopen-2023-080307.
Cardiovascular disease (CVD) is the leading cause of mortality worldwide, though it may be prevented by increasing physical activity (PA). When behaviour change techniques (BCTs) are bundled together, they increase PA, though which individual BCTs increase PA (and the behavioural mechanism of action (MoA) responsible for said increase) have not been studied. The aim of this study is to conduct a randomised factorial experiment to determine which of four BCTs significantly engage the proposed MoA-self-efficacy for PA-in adults at risk for CVD.
Eight hundred and twenty sedentary adults (18-74 years old) at risk for CVD will be recruited between September 2022 and June 2025 to a fully remote, 24-week randomised BCT intervention. To identify those who might benefit from this intervention, we define self-reported walking <7500 steps per day as 'sedentary'. Following a 4-week run-in period to confirm sedentary behaviour and adherence to the study protocol, 624 eligible participants will be randomised to an 8-week intervention period. A full factorial randomised experiment will be conducted with 16 possible conditions: one will receive no BCTs (no-BCT condition), another will receive all four, and 14 will receive a unique combination of BCTs. During the intervention, participants will receive their randomised daily BCT(s) via text message. Daily steps will be continuously measured using an activity tracker. Self-efficacy for PA will be assessed bi-weekly via the Self-Efficacy for Walking Scale-Duration. Participants will complete a 12-week post-intervention follow-up period where steps will be monitored despite no BCTs being delivered. BCT(s) associated with increased daily step counts and increased self-efficacy for PA between run-in and study completion (week 12 of follow-up) will be determined alongside whether or not self-efficacy for PA mediates the association between each BCT and increased walking.
This trial was approved by the Northwell Health Institutional Review Board. The full factorial experimental trial results will be published in a peer-reviewed journal. Data from this clinical trial will be made available on reasonable request.
clinicaltrials.gov; Identifier: NCT05425641, 06/21/2022.
心血管疾病（CVD）是全球主要的死亡原因，不过增加身体活动（PA）或许可以预防该病。当行为改变技术（BCTs）组合在一起时，它们能增加身体活动，不过尚未研究过哪些个体行为改变技术能增加身体活动（以及导致这种增加的行为作用机制（MoA））。本研究的目的是进行一项随机析因实验，以确定在有心血管疾病风险的成年人中，四种行为改变技术中的哪一种能显著激发所提出的身体活动自我效能作用机制。
2022年9月至2025年6月期间，将招募820名有心血管疾病风险的久坐不动成年人（18 - 74岁）参与一项为期24周的完全远程随机行为改变技术干预。为了确定哪些人可能从该干预中受益，我们将每天自我报告步行步数<7500步定义为“久坐不动”。在经过4周的磨合期以确认久坐行为并遵守研究方案后，624名符合条件的参与者将被随机分配到为期8周的干预期。将进行一项全因子随机实验，有16种可能的情况：一种情况将不接受任何行为改变技术（无行为改变技术条件），另一种情况将接受全部四种，还有14种情况将接受行为改变技术的独特组合。在干预期间，参与者将通过短信接收他们随机分配的每日行为改变技术。将使用活动追踪器持续测量每日步数。将通过步行自我效能量表 - 持续时间每两周评估一次身体活动自我效能。参与者将完成为期12周的干预后随访期，在此期间尽管不提供行为改变技术，但仍会监测步数。将确定在磨合期和研究结束（随访第12周）之间与每日步数增加和身体活动自我效能增加相关的行为改变技术，以及身体活动自我效能是否介导每种行为改变技术与步行增加之间的关联。
本试验已获得诺斯韦尔健康机构审查委员会的批准。全因子实验性试验结果将发表在同行评审期刊上。可根据合理请求提供该临床试验的数据。
clinicaltrials.gov；标识符：NCT05425641，2022年6月21日。
