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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG063786 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Butler, PhD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Health System Science | New Hyde Park | New York | 11042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41621469 | Derived | 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. |
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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.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2025 | Feb 23, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| Baseline (first 2 weeks of study) and last 2 weeks of intervention |
| 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. | Baseline to intervention period (12 weeks) |
| 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. | Baseline to intervention period (12 weeks) |
| D009422 |
| Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |