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临床试验/NCT04967313
NCT04967313已完成1 期

A Randomized, Controlled Trial to Test Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults

Northwell Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月5日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Within-person Change in Daily Steps.

研究概览

简要总结

The purpose of this pilot study is to determine the feasibility of using personalized trial methods in a virtual research study with Northwell employees aged 45-75 years old to increase low-intensity walking by 2,000 steps per day/5 days per week using four behavior change techniques (BCTs), provided in random order, and shown to have been effective in changing physical activity. The study will include a two-week baseline period during which levels of physical activity and adherence to the trial protocol will be evaluated. Individuals meeting adherence criteria will be randomized to the eight-week BCT intervention.

详细描述

The purpose of this pilot study is to determine the feasibility of using personalized trial methods in a virtual research study with Northwell employees aged 45-75 years old to increase low-intensity walking by 2,000 steps per day/five days per week using four behavior change techniques (BCTs), provided in random order, and shown to have been effective in changing physical activity. This pilot will help determine if a personalized, virtual trial design can have widespread use in future research and clinical practice. The investigators will randomize 60 participants. Participants will complete a two-week baseline period during which they will be asked to wear a Fitbit device all day and night, even while they are sleeping, and to acknowledge receipt of a daily text message that is not an activity prompt. Baseline participants will be instructed to sync their Fitbit device by opening the Fitbit app on their phone at least every two days. After completion of the baseline period, a clinical research coordinator will review individual adherence to Fitbit wear and to survey responses. Adherence to Fitbit wear will be defined as recorded activity of greater than 10 hours a day. Text message adherence will be defined as responding to a given text message. Baseline participants that do not achieve at least 80% adherence of Fitbit wear and text responsiveness during the two weeks of the baseline period will be withdrawn from the study. Those that maintain at least 80% adherence will be randomized to one of their selected behavior change techniques to begin their pilot personalized trial. Participants who are randomized to receive intervention sequences will receive email confirmation including their protocol timeline. Enrollment will continue until up to 60 participants have been randomized. Individuals in the intervention period will receive four BCTs: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. BCTs will be delivered individually to participants over the course of eight weeks in four two-week blocks. The order of BCT administration will be randomized by the study statistician. Participants may receive additional text messages to those outlined above with important reminders to sync their data as needed. Upon completion, participants in the personalized trials phase will receive an individual report that demonstrates their walking responses in relation to their selected BCTs. After receiving the report, clinical research coordinators will contact participants to respond to questions and to obtain feedback about their personalized trials experience.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 - 75 years old of age
  • Fluent in English
  • Employed in the Northwell Health system
  • Community-dwelling
  • Report they are in good general health, walk regularly and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program
  • Owns and can regularly access a smartphone capable of receiving text messages
  • Owns and can regularly access an e-mail account

排除标准

  • < 45 years old or > 75 years old
  • Unable to speak/comprehend English
  • Not employed in Northwell Health system
  • Have self-reported poor health, limited mobility and/or have been advised by a clinician not to increase their low-intensity walking
  • Pregnancy
  • Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder

结局指标

主要结局

Within-person Change in Daily Steps.

时间窗: Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level. This will yield 70 daily measurements of physical activity over the course of the 10-week study.

Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline and intervention phases to generate average daily steps in each phase. Changes in daily steps between baseline and intervention phases will be compared using Generalized Linear Mixed Model analyses. Changes in daily steps between intervention and baseline will be represented using a regression parameter.

Participant Satisfaction With Personalized Trial Components.

时间窗: Assessed once after completion of the study at 10 weeks.

Participants will rate their satisfaction with the Personalized Trial overall and with individual elements of the trial in a satisfaction survey developed for this trial. Participants will rate 9 items assessing satisfaction with methods and process of the trial on a 4-point Likert scale with responses ranging from "0 - Not at all satisfied" to "3 - Very satisfied". Higher scores indicate greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.

次要结局

  • Participant Attitudes and Opinions Towards Personalized Trials.(Assessed once after completion of the study at 10 weeks.)
  • Self-Efficacy for Walking(Assessed at baseline, week 2, week 4, week 6, week 8, and week 10.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karina Davidson

Senior Vice President, Research & Dean of Academic Affairs

Northwell Health

研究点 (1)

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