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

May 19, 2026 updated by: Northwell Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11042
        • Institute of Health System Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This will be a 12-week, single-arm, multi-component, personalized BCT intervention. We will provide participants 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.
Behavioral: Behavior Change Technique Package

Behavior Change Technique 1: Goal setting (Behavior) (BCT 1.1). Goal setting for behavior is defined as setting a goal for the behavior to be achieved.

Behavior Change Technique 2: Action planning (BCT 1.4). Action planning is defined as detailing the plan of where, for how long, and at what time taking medication is going to be performed.

Behavior Change Technique 3: Self-monitoring of behavior (BCT 2.3). Self-monitoring of behavior is defined as monitoring and recording behavior.

Behavior Change Technique 4: Prompts/Cues (BCT 7.1) This BCT is defined as prompt rehearsal and repetition of the behavior in the same context repeatedly, so that the context elicits the behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary indicator of habit formation
Time Frame: 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.
Baseline to intervention period (12 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mark Butler, PhD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Actual)

May 14, 2026

Study Completion (Actual)

May 15, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0045
  • 2P30AG063786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Scientific data generated as a result of this research will be shared broadly via OpenScience: https://cos.io/ or a comparable data registry. There will be no identifiable data posted publicly.

IPD Sharing Time Frame

The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified individual participant data will be made available at time of primary outcome manuscript publication, whichever comes last. We anticipate this data to be available on the Open Science Framework or comparable data registry indefinitely.

IPD Sharing Access Criteria

All de-identified study data and supporting information will be stored on the Open Science Framework or comparable data registry, a free web application with no access restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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