Goodwin Ashley M, Friel Ciaran, Miller Danielle, Vicari Frank, Duer-Hefele Joan, Chandereng Thevaa, Davidson Karina W, Alfano Catherine M, Cheung Ying Kuen, Butler Mark J
Northwell Health, Feinstein Institutes for Medical Research, Institute of Health System Science, New Hyde Park, New York, USA
Northwell Health, Feinstein Institutes for Medical Research, Institute of Health System Science, New Hyde Park, New York, USA.
BMJ Open. 2025 Aug 5;15(8):e090789. doi: 10.1136/bmjopen-2024-090789.
To identify the minimum effective dose of a multi-behaviour change technique (BCT) intervention to increase physical activity among individuals on primary statin therapy using the time-to-event continual reassessment method (TiTE-CRM).
A large New York metropolitan area healthcare system comprising approximately 85 000 employees and 5.5 million patient encounters annually.
42 participants enrolled in 13 cohorts of 3 participants, 1 cohort of 2 participants and 1 cohort of 1 participant. The sample was composed of 16.7% individuals aged 66 and older (n=7), 64.3% women (n=27), 69.0% white individuals (n=29) and 7.1% Hispanic individuals (n=3).
A variable-duration, four-BCT text message intervention and a 2-week follow-up. Dose assignment relied on TiTE-CRM to adjust the duration of the intervention based on adherence of participants in prior cohorts. Five mechanisms of action (MoAs) were assessed: self-efficacy, intrinsic regulation, discrepancy in behaviour, motivation and barriers to activity.
The primary outcome measure was the proportion of participants who achieved a 2000 step/day increase between baseline and follow-up. The secondary outcomes were within-participant changes in daily steps (examined as a continuous variable at the daily level) and potential MoAs for increased physical activity.
Of the 40 participants who completed follow-up, 7 (17.5%) achieved the goal of 2000 or more steps per day during their follow-up period. Though participants did increase the number of steps they walked during the intervention (B(SE)=373.1 (154.7) steps; p=0.016), there was no association between increased intervention duration and increased daily average steps. The intervention was also associated with increases in self-efficacy (p=0.002), intrinsic regulation (p=0.037), discrepancy in behaviour (p<0.001) and motivation (p=0.039).
The results of this trial did not show a traditional dose-response curve to increasing the length of a multicomponent BCT intervention. Results did show that the intervention successfully increased steps during the intervention period and that the benefit of the intervention dwindled during follow-up. Further, potential MoAs for the intervention were confirmed.
NCT05273723.
采用事件发生时间连续重新评估法（TiTE-CRM）确定多行为改变技术（BCT）干预措施的最低有效剂量，以增加接受他汀类药物初始治疗的个体的身体活动量。
一个位于纽约大都市区的大型医疗系统，每年约有85000名员工，患者就诊量达550万次。
42名参与者，分为13个每组3人的队列、1个每组2人的队列和1个每组1人的队列。样本中66岁及以上个体占16.7%（n = 7），女性占64.3%（n = 27），白人占69.0%（n = 29），西班牙裔占7.1%（n = 3）。
一种持续时间可变的、包含四种BCT的短信干预及为期2周的随访。剂量分配依靠TiTE-CRM，根据先前队列参与者的依从性来调整干预持续时间。评估了五种作用机制（MoA）：自我效能感、内在调节、行为差异、动机和活动障碍。
主要结局指标是在基线至随访期间每天步数增加2000步的参与者比例。次要结局指标是参与者每日步数的个体内变化（在每日水平上作为连续变量进行检查）以及身体活动增加的潜在MoA。
在完成随访的40名参与者中，7名（17.5%）在随访期间达到了每天2000步或更多步的目标。尽管参与者在干预期间确实增加了行走步数（B（标准误）= 373.1（154.7）步；p = 0.016），但干预持续时间的增加与每日平均步数的增加之间没有关联。该干预还与自我效能感增加（p = 0.002）、内在调节增加（p = 0.037）、行为差异增加（p < 0.001）和动机增加（p = 0.039）有关。
该试验结果未显示多成分BCT干预措施延长长度后呈现传统的剂量反应曲线。结果确实表明，干预在干预期间成功增加了步数，且干预的益处在随访期间逐渐减少。此外，还证实了干预的潜在MoA。
NCT05273723。
