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

NCT06803797 | Active Not Recruiting

• 2 other identifiers: 24-00452P30AG063786
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inactivity, Physical

Keywords

caregiver; Alzheimer's disease; Alzheimer Related Dementia; physical activity; behavior change techniques; habit formation

Outcome Measures

Primary Outcomes (1)

• Binary indicator of habit formation

  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 Outcomes (3)

• 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)

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Behavior Change Technique Package BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Institute of Health System Science

New Hyde Park, New York, 11042, United States

Location

Related Publications (1)

• Miller D, Jordan L, Lambert S, Goodwin AM, Sinvani L, Perrin A, Cheung YK, Davidson KW, Butler MJ. Protocol for a single-arm, multi-component behavior change technique (BCT) intervention to develop a walking habit among caregivers for persons with Alzheimer disease and related dementias (ADRD). Contemp Clin Trials. 2026 Mar;162:108248. doi: 10.1016/j.cct.2026.108248. Epub 2026 Jan 30.

  PMID: 41621469 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mark Butler, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Prompt/Cue) that have been associated with habit formation theory and development of physical activity habits in prior research.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 18, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)