A Trial of Habit Formation Theory for Exercise in Older Adults

• ClinicalTrials.gov Identifier: NCT04869644
• Recruitment Status: Recruiting
• First Posted: May 3, 2021
• Last Update Posted: December 20, 2021
• Sponsor: Northwell Health
• Collaborators: National Institute on Aging (NIA); Columbia University
• Information provided by (Responsible Party): Karina Davidson, Northwell Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedentary Behavior; Aging; Activity, Motor; Behavior, Health	Behavioral: Goal setting; Behavioral: Action Planning; Behavioral: Self-monitoring of behavior; Behavioral: Behavioral Practice/Rehearsal; Behavioral: Habit Formation	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
• Actual Study Start Date: March 26, 2021
• Estimated Primary Completion Date: March 1, 2022
• Estimated Study Completion Date: March 1, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention: Behavioral Change Techniques to encourage Habit Formation; Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps 5 days per week. Participants will be enrolled for a baseline period lasting 2 weeks where their average daily activity level will be assessed using a Fitbit device to generate an average daily step counts. Following completion of baseline, participants will be asked to generate a walking plan with the goal of walking an additional 2,000 steps above their baseline activity level on 5 days per week. This walking plan will include details about day of the week, time of day, and location of walking. Once participants have completed their walking plan, they will receive daily texts based on the 5 identified BCTs for the duration of the 10-week intervention. All BCTs will be delivered daily. The goal of the text messages will be to encourage habit formation for walking behavior.

Behavioral: Goal setting; Goal setting: set or agree on a goal defined in terms of behavior to be achieved.; Behavioral: Action Planning; Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity.; Behavioral: Self-monitoring of behavior; Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.; Behavioral: Behavioral Practice/Rehearsal; Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.; Behavioral: Habit Formation; Prompt rehearsal & repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.

Outcome Measures

Primary Outcome Measures :

1. Change in Automaticity Score. [ Time Frame: 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. ]
   Automaticity of behavior is assessed by a 4-item questionnaire asking about the automaticity of participant's walking behavior using a 4-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Items are summed together to form a total score ranging from 0 to 12, with higher scores indicating that participant's new walking behaviors have become more habitual and automatic. Change in daily automaticity levels over the course of the intervention period will be examined until scores level out and reach a score of 8 or more on 7 consecutive days. Participants will be judged to have reached an asymptote at this point in time. Time-to-event analyses will be conducting examining participant differences in reaching an asymptote for automaticity and overall time-to-event will represented using Kaplan-Meier curves.
2. Participant Satisfaction with Personalized Trial Components. [ Time Frame: Assessed once after completion of the study at 12 weeks. ]
   Participants will rate their satisfaction with the Personalized Trial overall and with individual elements of the trial in a satisfaction survey developed for this trial. Participants will rate 9 items assessing satisfaction with methods and process of the trial on a 4-point Likert scale with responses ranging from "Not at all satisfied" to "Very satisfied". Means and standard deviations will be reported for each element of satisfaction.

Secondary Outcome Measures :

1. Within-person change in Daily Steps. [ Time Frame: Steps will be assessed continuously via worn activity tracker and step counts will be reported daily. ]
   Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline and intervention phases to generate average daily steps in each phase. Changes in daily steps between baseline and intervention phases will be compared using Generalized Linear Mixed Model analyses.
2. Proportion of Days Adhering to Walking Habit. [ Time Frame: Assessed once after completion of the study at 12 weeks. ]
   This is assessed using a single yes/no item assessed daily asking participants "Did you walk according to your walking plan today?". For each participant, we will identify the proportion of days during the 10-week intervention where the participant adhered to the walking plan. Proportions of adherence will reported across all participants with means and standard deviations.
3. Participant Attitudes and Opinions towards Personalized Trials. [ Time Frame: Assessed once after the completion of the intervention period. ]
   Participants will be asked via survey about their attitudes and opinions regarding the personalized trial implementation (e.g., Did the trial feel burdensome?). Participants will rate items on a 7-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Scores on each item will be reported with means and standard deviations.
4. Participant Adherence to Self-Monitoring. [ Time Frame: 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. ]
   This will be measured via a single survey item delivered following a participant's scheduled walking time asking them to record the number of steps they took on their walk. Individuals who complete this item and record their steps will be judged to be adherent to self-monitoring of their walking behavior. Participant adherence will be aggregated over the course of the 10-week intervention and will be reported as proportion of days adherent to self-monitoring. Proportions of adherence will be reported across all participants with means and standard deviations.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Joan Duer-Hefele, RN, MA; 6467667153; jduerhefele@northwell.edu

Locations

United States, New York

Center for Personalized Health; Recruiting

New York, New York, United States, 10022

Contact: Joan Duer-Hefele, RN 646-766-7153 jduerhefele@northwell.edu

Sponsors and Collaborators

Northwell Health

National Institute on Aging (NIA)

Columbia University

Investigators

• Principal Investigator: Karina W Davidson; Northwell Health

More Information

• Responsible Party: Karina Davidson, Senior Vice President, Research & Dean of Academic Affairs, Northwell Health
• ClinicalTrials.gov Identifier: NCT04869644
• Other Study ID Numbers: 20-1182; P30AG063786-01 ( U.S. NIH Grant/Contract )
• First Posted: May 3, 2021
• Last Update Posted: December 20, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: The study protocol, including he 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, pooled individual participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karina Davidson, Northwell Health:

Habit Formation; Physical Activity; Behavior Change; Virtual; Personalized Trial; Personalized; Feasibility