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Completed

NCT Number: NCT06801912

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

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.

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Key information

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)

    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.

Secondary outcomes

  1. Habit formation association with changes in automaticity

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

    Examining whether an hourly walking habit formation will be associated with positive changes in cognitive 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; a positive change is defined as a difference of greater than zero. The rate of habit formation will be compared between the group of participants whose automaticity increased and the participants whose automaticity did not using a Fisher's exact test. Finally, logistic regression will be utilized to assess the effects of automaticity on 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)

    Longitudinal associations between the intervention, automaticity, and habitual walking over time will be examined using univariate logistic regression models. These models will provide preliminary estimates of how automaticity change at a given week will impact habit formation, thus informing how the timing of automaticity change will impact habit. Further, weekly automaticity changes will be explored together in a multivariate Bayesian logistic regression model, which will be trained using iPIPE.238

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

    Time frame: Baseline to intervention period (12 weeks)

    To examine the heterogeneity of treatment effects for habit formation and on changes in automaticity, analyses of HTEs across participants will be conducted. This will involve examining the heterogeneity in time to achieving habitual hourly 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 an Hourly Activity Habit Among Caregivers for Persons 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 30, 2025
Registry last updated
May 28, 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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