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临床试验/NCT06801912
NCT06801912已完成不适用

A Behavior Change Technique (BCT) Intervention to Develop an Hourly Activity Habit Among Caregivers for Persons Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)

Northwell Health2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Binary indicator of habit formation

研究概览

简要总结

This 12-week trial will test the efficacy of a personalized, multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual hourly physical activity among care providers of persons with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) via the key mechanism of behavior change (MoBC) of automaticity.

The main question it aims to answer is whether a multi-component, personalized BCT intervention to increase habitual walking of >250 steps/hour will lead to successful development of habitual hourly walking among 50% of caregivers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identify as a caregiver (formal/paid or informal/unpaid) for persons with Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)
  • Age >=18 and <=85
  • Speak English or Spanish as primary language
  • Self-report low levels of physical activity or walking

排除标准

  • Individuals who self-report having been informed by a clinician it is medically or physically unsafe to engage in a walking intervention
  • Does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet
  • Does not own or have access to an email address
  • Lives outside the United States

研究组 & 干预措施

Behavior Change Technique Package

Experimental

This will be a 12-week, single-arm, multi-component, personalized BCT intervention. Participants will be provided with 4 BCTs daily (Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue) that have been associated with habit formation theory and development of physical activity habits in prior research.

干预措施: Behavior Change Technique Package (Behavioral)

结局指标

主要结局

Binary indicator of habit formation

时间窗: Baseline to intervention period (12 weeks)

The primary outcome will be a binary indicator of habit formation. A null hypothesis rate of 30 percent will be used. There will be a comparison of the achieved proportion of habitual walking versus this null level, using a 1-sample binomial test with a 2-sided alpha at 5 percent. For the purposes of this current analysis, it is assumed that 50 percent of the sample will achieve habitual hourly walking following the BCT intervention to encourage habit formation. Rate of habit formation will be summarized using the observed proportion along with a 95 percent confidence interval.

次要结局

  • Habit formation association with changes in automaticity(Baseline (first 2 weeks of study) and last 2 weeks of intervention)
  • Longitudinal association between automaticity and habitual walking over time(Baseline to intervention period (12 weeks))
  • Heterogeneity of treatment effects for habit formation and on changes in automaticity(Baseline to intervention period (12 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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