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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2021

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

March 26, 2021

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2021

Completed

15 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed

6 months until next milestone

Results Posted

Study results publicly available

November 30, 2022

Completed

Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

April 18, 2021

Results QC Date

August 26, 2022

Last Update Submit

November 4, 2022

Conditions

Sedentary Behavior Aging Activity, Motor Behavior, Health

Keywords

Habit FormationPhysical ActivityBehavior ChangeVirtualPersonalized TrialPersonalizedFeasibility

Outcome Measures

Primary Outcomes (2)

Change in Automaticity Score.
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. The proportion of the sample that has achieved automaticity will be reported as a number with percentage \[N(%)\]. 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.
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.
Participant Satisfaction With Personalized Trial Components.
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 "0 - Not at all satisfied" to "3 - Very satisfied". Higher scores indicate greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.
Assessed once after completion of the study at 12 weeks.

Secondary Outcomes (4)

Within-person Change in Daily Steps.
Steps will be assessed continuously via worn activity tracker and step counts will be reported daily.
Proportion of Days Adhering to Walking Habit.
Assessed once after completion of the study at 12 weeks.
Participant Attitudes and Opinions Towards Personalized Trials.
Assessed once after the completion of the intervention period.
Participant Adherence to Self-Monitoring.
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.

Study Arms (1)

Intervention: Behavioral Change Techniques to encourage Habit Formation

EXPERIMENTAL

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 settingBehavioral: Action PlanningBehavioral: Self-monitoring of behaviorBehavioral: Behavioral Practice/RehearsalBehavioral: Habit Formation