背景:身体活动对成功衰老至关重要,但是大多数中年人和老年人动作不够。研究表明,即使是很小的活动增加也可以对降低风险和改善生活质量产生重大影响。一些行为改变技术(BCT)可以增加活动,但先前对其有效性的研究主要是在受试者间试验和总体上对其进行了测试。这些设计方法,虽然健壮,未能确定对给定个体最有影响力的BCT。相比之下,一个个性化的,或N-of-1,试验设计可以评估一个人对每个具体干预的反应。
目的:本研究旨在测试可行性,可接受性,以及远程提供的个性化行为干预以增加低强度体力活动的初步有效性(即,步行)在45至75岁的成年人中。
方法:干预措施将持续10周,从2周的基线期开始,然后是4个BCT(目标设定,自我监控,反馈,和行动计划)一次交付一个,每人2周。总的来说,60名参与者将在基线后随机分配到24个干预序列中的1个。身体活动将由可穿戴活动跟踪器连续测量,干预成分和结果措施将通过电子邮件交付和收集,短信,和调查。将使用具有自回归模型的广义线性混合模型来检查总体干预对步数相对于基线的影响,该模型考虑了跨时间每日步数的可能自相关和线性趋势。参与者对研究组成部分的满意度以及对个性化试验的态度和意见将在干预结束时进行测量。
结果:每日步数的汇总变化将在基线和个体BCT之间以及基线与总体干预之间报告。自我效能评分将在基线和个体BCT之间以及基线和整体干预之间进行比较。将报告调查措施的平均值和SD(参与者对研究组成部分的满意度以及对个性化试验的态度和意见)。
结论:评估提供个性化服务的可行性和可接受性,针对中老年人的远程身体活动干预将告知需要采取哪些步骤来远程扩展到完全动力和受试者内的实验设计。单独检查每个BCT的效果将允许评估其独特的影响,并支持未来行为干预的设计。在使用个性化试验设计时,每个BCT的个体反应的异质性可以量化,并告知美国国立卫生研究院以后的干预研究阶段.
背景:clinicaltrials.govNCT04967313;https://clinicaltrials.gov/ct2/show/NCT04967313。
■RR1-10.2196/43418。
BACKGROUND: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1,
trial design can assess a person\'s response to each specific intervention.
OBJECTIVE: This
study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years.
METHODS: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the
study components and attitudes and opinions toward personalized trials will be measured at the intervention\'s conclusion.
RESULTS: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with
study components and attitudes and opinions toward personalized trials).
CONCLUSIONS: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized
trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials.
BACKGROUND: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313.
UNASSIGNED: RR1-10.2196/43418.