Sedentary Behavior
Conditions
Keywords
caregiver, Alzheimer's disease, Alzheimer Related Dementia, behavior change techniques, habit formation, sedentary behavior
Brief summary
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.
Interventions
BEHAVIORALBehavior Change Technique Package
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.
Sponsors
Northwell Health
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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 Prompts/Cues) that have been associated with habit formation theory and development of physical activity habits in prior research.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binary indicator of habit formation | 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
| Measure | Time frame | Description |
|---|---|---|
| Habit formation association with changes in automaticity | 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. |
| Longitudinal association between automaticity and habitual walking over time | 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 |
| Heterogeneity of treatment effects for habit formation and on changes in automaticity | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshley Goodwin, PhD
Northwell Health
Outcome results
None listed