Inactivity, Physical
Conditions
Keywords
caregiver, Alzheimer's disease, Alzheimer Related Dementia, physical activity, behavior change techniques, habit formation
Brief summary
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.
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 Prompt/Cue) 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Habit formation association with changes in automaticity | 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. |
| Longitudinal association between automaticity and habitual walking over time | 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. |
| Heterogeneity of treatment effects for habit formation and on changes in automaticity | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Butler, PhD
Northwell Health
Outcome results
None listed