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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Habit formation association with changes in automaticity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Goodwin, 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 |
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. Data is anticipated 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 |
| 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 Prompts/Cues) 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 | 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 | Baseline to intervention period (12 weeks) |
| Heterogeneity of treatment effects for habit formation and on changes in automaticity | 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. | Baseline to intervention period (12 weeks) |
| D009422 |
| Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |