A BCT Intervention for an Hourly Activity Habit Among Caregivers for Persons With AD/ADRD

Not Applicable

Recruiting

• Conditions: Sedentary Behavior

• Registration Number: NCT06801912
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study Start: 2025-03-25
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Binary indicator of habit formation	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.

Secondary Outcome Measures

Name	Time	Method
Habit formation association with changes in automaticity	Baseline (first 2 weeks of study) and last 2 weeks of intervention	Examining whether an hourly walking habit formation will be associated with positive changes in cognitive automaticity using Fisher's exact test (5%, 2-sided). Specifically, for each participant, the difference between average automaticity during the last 2 weeks of intervention and average baseline automaticity will be calculated; a positive change is defined as a difference of greater than zero. The rate of habit formation will be compared between the group of participants whose automaticity increased and the participants whose automaticity did not using a Fisher's exact test. Finally, logistic regression will be utilized to assess the effects of automaticity on development of a daily walking habit, with adjustment for other factors, such caregiver demographic characteristics and factors related to caregiving.
Longitudinal association between automaticity and habitual walking over time	Baseline to intervention period (12 weeks)	Longitudinal associations between the intervention, automaticity, and habitual walking over time will be examined using univariate logistic regression models. These models will provide preliminary estimates of how automaticity change at a given week will impact habit formation, thus informing how the timing of automaticity change will impact habit. Further, weekly automaticity changes will be explored together in a multivariate Bayesian logistic regression model, which will be trained using iPIPE.238
Heterogeneity of treatment effects for habit formation and on changes in automaticity	Baseline to intervention period (12 weeks)	To examine the heterogeneity of treatment effects for habit formation and on changes in automaticity, analyses of HTEs across participants will be conducted. This will involve examining the heterogeneity in time to achieving habitual hourly walking due to the BCT intervention.

Trial Locations

Locations (1)

Institute of Health System Science; 🇺🇸 New Hyde Park, New York, United States