Clinical trial NCT06801912: A BCT Intervention for an Hourly Activity Habit Among Caregivers for Persons With AD/ADRD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Keywords: caregiver
Alzheimer's disease
Alzheimer Related Dementia
behavior change techniques
habit formation
sedentary behavior
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a 12-week, NIH Stage II Behavioral Trial, consisting of a single-arm, multi-component, personalized BCT intervention trial, enrolling caregivers of persons with AD/ADRD. Participants will be provided with 4 BCTs daily (Goal Setting, Action Planning, Self-Monitoring, and Prompts/Cues) that have been associated with habit formation theory and development of physical activity habits in prior research.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Binary indicator of habit formation
timeFrame: Baseline to intervention period (12 weeks)
Secondary outcomes:
measure: Habit formation association with changes in automaticity
timeFrame: Baseline (first 2 weeks of study) and last 2 weeks of intervention
measure: Longitudinal association between automaticity and habitual walking over time
timeFrame: Baseline to intervention period (12 weeks)
measure: Heterogeneity of treatment effects for habit formation and on changes in automaticity
timeFrame: Baseline to intervention period (12 weeks)
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Institute of Health System Science
state: New York
Study officials:
affiliation: Northwell Health
name: Ashley Goodwin, PhD
role: PRINCIPAL_INVESTIGATOR
References: