Clinical trial NCT04869644: A Trial of Habit Formation Theory for Exercise in Older Adults
Official title: A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sedentary Behavior
Aging
Activity, Motor
Behavior, Health
Keywords: Habit Formation
Physical Activity
Behavior Change
Virtual
Personalized Trial
Personalized
Feasibility
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Columbia University
First posted: 2021-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This personalized trial will evaluate the effects of five behavioral change techniques (BCTs) described in Habit Formation Theory (Goal setting, Action Planning, Self-Monitoring, Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell employees aged 45-75 years old.

Detailed description: This pilot study uses a virtual, single-arm, personalized design to evaluate the effects of the five behavioral change techniques (BCTs) described in Habit Formation Theory (Goal Setting, Action Planning, Self-Monitoring, Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell employees aged 45-75 years old. Up to sixty participants will complete a 12-week personalized trial of their walking behavior and assess all five behavioral change techniques described in habit formation theory. Prior to beginning the trial, participants will be sent a Fitbit® activity tracking watch that monitors number of steps per day. Participants will be instructed to wear the Fitbit device all day and night, even when they are sleeping. The single-arm, personalized trial will be comprised of a 2-week baseline/screening phase and a 10-week intervention phase. During the baseline phase, participant's baseline levels of physical activity (operationalized as average steps per day measured using the Fitbit device) and adherence to the trial protocol (operationalized as wearing the Fitbit device for a minimum of 10 hours per day and completing daily survey measure) will be assessed. Participants who are adherent to the study protocol, defined as adherence to Fitbit use and survey measures on 80% or more days during baseline, will proceed to the intervention phase. At the beginning of the intervention, participants will develop a walking plan with the goal of walking 2,000 more steps per day than their average levels of baseline activity (e.g., if you walked an average of 6,000 steps per day during baseline, the new goal would be 8,000). The walking plan will include details about the day, time, and location of walking behavior. Participants will commit to walking according to this plan 5 days per week (e.g., walking 8,000 steps per day on 5 planned days. A time-sensitive text of all 5 BCTs will delivered to the participant when the context (e.g., day of week, time of day) that they pre-selected is encountered. Participants will later receive a text message with a link to a secure survey in which they will note whether they engaged with the five behavioral change techniques which were prompted. The goal of the intervention is to help participants make their walking behavior habitual and automatic. Participants will be assessed in terms of their satisfaction with the personalized trial design, their Fitbit-measured daily steps, adherence to their walking plan, and the automaticity of their walking behavior. After completion of the intervention phase, participants will be allowed to keep the Fitbit device.

Eligibility criteria: Inclusion Criteria:

Men and women who:

* Age 45 - 75 years old of age
* Fluent in English
* Employed in the Northwell Health system
* Community-dwelling
* Report they are in good general health, walk regularly and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program
* Owns and can regularly access a smartphone capable of receiving text messages
* Owns and can regularly access an e-mail account

Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial

* \< 45 years old or \> 75 years old
* Unable to speak/comprehend English
* Not employed in Northwell Health system
* Have self-reported poor health, limited mobility and/or have been advised by a clinician not to increase their low-intensity walking
* Pregnancy
* Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder

Primary outcomes:
measure: Change in Automaticity Score.
timeFrame: Assessed daily via online survey for participants across the duration of the 10-week intervention. Daily assessments will be aggregated by week to generate weekly means for automaticity.
measure: Participant Satisfaction With Personalized Trial Components.
timeFrame: Assessed once after completion of the study at 12 weeks.
Secondary outcomes:
measure: Within-person Change in Daily Steps.
timeFrame: Steps will be assessed continuously via worn activity tracker and step counts will be reported daily.
measure: Proportion of Days Adhering to Walking Habit.
timeFrame: Assessed once after completion of the study at 12 weeks.
measure: Participant Attitudes and Opinions Towards Personalized Trials.
timeFrame: Assessed once after the completion of the intervention period.
measure: Participant Adherence to Self-Monitoring.
timeFrame: Assessed daily via online survey for participants across the duration of the 10 week intervention. Daily responses will be aggregated across the intervention to determine an overall proportion of days adherent self-monitoring of behavior.
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Personalized Health
state: New York
Study officials:
affiliation: Northwell Health
name: Karina W Davidson
role: PRINCIPAL_INVESTIGATOR
References: