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Completed

NCT Number: NCT06803797

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

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Key information

Conditions

Inactivity, Physical Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Sedentary Behavior Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Health System Science

New Hyde Park, New York, 11042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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