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

NCT06801912 | Active Not Recruiting

• 2 other identifiers: 24-00422P30AG063786
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Binary indicator of habit formation

  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.

  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)

Behavior Change Technique Package

EXPERIMENTAL

This will be a 12-week, single-arm, multi-component, personalized BCT intervention. 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.

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.

Behavior Change Technique Package

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

MeSH Terms

Conditions

Sedentary Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashley Goodwin, 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 Prompts/Cues) that have been associated with habit formation theory and development of physical activity habits in prior research.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: March 25, 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. Data is anticipated 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)