BCT Intervention For Walking Habit Among Caregivers of People With AD/ADRD

NCT ID: NCT06803797

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2026-04-30

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.

Conditions

Inactivity, Physical

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Behavior Change Technique Package

Intervention Type: 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.

Interventions

Behavior 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Institute of Health System Science

New Hyde Park, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Butler, PhD

Role: CONTACT

markbutler@northwell.edu

646-995-8958

Ashley Goodwin, PhD

Role: CONTACT

agoodwin3@northwell.edu

646-995-8958

Facility Contacts

Danielle Miller, MPH

Role: primary

roybaltrials@northwell.edu

646-995-8958

Other Identifiers

2P30AG063786

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0045

Identifier Type: -

Identifier Source: org_study_id