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Inactivity, PhysicalNCT06803797

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

A study testing Behavior Change Technique Package in people with Inactivity, Physical, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Inactivity, Physical
What is being tested?
Behavior Change Technique Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
18 Mar 2025to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Institute of Health System Science

    New Hyde Park, New York, 11042

Other trials in United States

About this study

Official title: 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.

Being tested
Behavior Change Technique Package
Keywords
caregiver, Alzheimer's disease, Alzheimer Related Dementia, physical activity, behavior change techniques, habit formation
Medical subject headings
Sedentary Behavior, Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavior Change Technique PackageBehavioural

    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.

Study groups in NCT06803797
Study groupRoleWhat they receive
InterventionExperimentalThis 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.
Receives: Behavioral: Behavior Change Technique Package

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to intervention period (12 weeks)

Secondary outcomes (3)

  1. Habit formation association with changes in automaticity

    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.

    Measured: Baseline (first 2 weeks of study) and last 2 weeks of intervention

  2. Longitudinal association between automaticity and habitual walking over time

    Weekly automaticity and its association with habit formation using a multivariate Bayesian logistic regression model, trained using iPIPE,238 a novel statistical learning method.

    Measured: Baseline to intervention period (12 weeks)

  3. Heterogeneity of treatment effects for habit formation and on changes in automaticity

    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.

    Measured: Baseline to intervention period (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start18 Mar 2025
  3. Primary completion14 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803797
Sponsor's protocol ID
24-0045
Other IDs
2P30AG063786
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41621469

Questions about this trial

What is this clinical trial studying?

A study testing Behavior Change Technique Package in people with Inactivity, Physical, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binary indicator of habit formation (time frame: Baseline to intervention period (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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