BCT Intervention For Walking Habit Among Caregivers of People With AD/ADRD

Not Applicable

Recruiting

• Conditions: Inactivity, Physical

• Registration Number: NCT06803797
• Lead Sponsor: Northwell Health

Brief Summary

This 12-week trial will test the efficacy of a multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual physical activity (defined as regular walking of 1,000 or more steps during a one-hour period on 7 consecutive days according to a personalized walking plan) among care providers of persons with AD/ADRD via the key mechanism of behavior change (MoBC) of automaticity.

The main question it aims to answer whether a multi-component, personalized BCT intervention to increase a walking habit of 1,000 steps/day will lead to successful development of habitual walking among 60 percent of caregivers enrolled.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study Start: 2025-03-18
• 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)	Binary indicator of habit formation, defined as a daily walking habit of 1,000 steps during a pre-determined period identified during baseline. Assessing the efficacy of the personalized BCT intervention by testing the null hypothesis of habit formation rate equal to 40% using a 1-sample binomial test at the 5% level 2-sided. Rate of habit formation will be summarized using the observed proportion, along with a 95% 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	Examine whether habit formation will be associated with positive changes in 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. Rate of habit formation between the group of participants, whose automaticity increased and the participants whose automaticity did not, will be compared using a Fisher's exact test. Logistic regression will be used to assess the effects of automaticity on the 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)	Weekly automaticity and its association with habit formation using a multivariate Bayesian logistic regression model, trained using iPIPE,238 a novel statistical learning method.
Heterogeneity of treatment effects for habit formation and on changes in automaticity	Baseline to intervention period (12 weeks)	Conduct analyses of heterogeneity of treatment effects (HTEs) across participants. This will involve examining the heterogeneity in time to achieving habitual daily walking due to the BCT intervention.

Trial Locations

Locations (1)

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