A Phase 1 interventional study of Goal setting and Action Planning in Sedentary Behavior, Aging and Activity, Motor, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Northwell Health · Phase 1, Interventional, and Health services research
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.
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.
Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Men and women who:
Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial
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 · Behavioral: Action Planning · Behavioral: Self-monitoring of behavior · Behavioral: Behavioral Practice/Rehearsal · Behavioral: Habit Formation
Goal setting: set or agree on a goal defined in terms of behavior to be achieved.
Action planning: prompt detailed planning of performance of behavior (must include a setting \[walking to the mailbox\], frequency, duration, and intensity.
Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.
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.
Prompt rehearsal \& repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.
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.
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.
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.
Time frame: Assessed once after completion of the study at 12 weeks.
Within-person Change in Daily Steps.
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.
Time frame: Steps will be assessed continuously via worn activity tracker and step counts will be reported daily.
Proportion of Days Adhering to Walking Habit.
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.
Time frame: Assessed once after completion of the study at 12 weeks.
Participant Attitudes and Opinions Towards Personalized Trials.
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 "0 - Strongly Disagree" to "6 - Strongly Agree". Higher scores indicate greater levels of agreement. Scores on each item will be reported with means and standard deviations.
Time frame: Assessed once after the completion of the intervention period.
Participant Adherence to Self-Monitoring.
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.
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.
| Milestone | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Started | 114 |
| Did not meet or complete inclusion criteria | 35 |
| Did not consent to study | 30 |
| Completed | 49 |
| Not completed | 65 |
| Milestone | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Started | 49 |
| Withdrew from study | 5 |
| Completed | 44 |
| Not completed | 5 |
| Milestone | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Started | 44 |
| Ineligible after baseline | 8 |
| Withdrew from study | 2 |
| Completed | 34 |
| Not completed | 10 |
| Milestone | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Started | 34 |
| Discontinued intervention | 2 |
| Completed | 32 |
| Not completed | 2 |
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.
| Participants | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Change in Automaticity Score. | 17 |
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.
| Score for Participant Satisfaction Item | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| "Please rate your overall satisfaction with the BCT text messages" | 2.53 ± 0.78 |
| "Please rate your satisfaction with the ease of using the BCT text messages" | 2.97 ± 0.18 |
| "Please rate your satisfaction with the overall effectiveness of the BCT text messages" | 2.50 ± 0.82 |
| "Video explanations and demonstrations of study devices and procedures" | 2.38 ± 0.67 |
| "Text messaging for reminders (e.g. synch your Fitbit)" | 2.76 ± 0.54 |
| "Text messaging for data collection (i.e. surveys)" | 2.65 ± 0.67 |
| "Use of the Fitbit device to track your activity and sleep" | 2.60 ± 0.60 |
| "Study communications" | 2.67 ± 0.58 |
| "Presentation of your results" | 2.38 ± 0.92 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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 "0 - Strongly Disagree" to "6 - Strongly Agree". Higher scores indicate greater levels of agreement. Scores on each item will be reported with means and standard deviations.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Data for adverse events were collected for each participant over 12 weeks (2-week baseline and 10-week intervention).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention: Behavioral Change Techniques to Encourage Habit Formation | 0/44 (0%) | 0/44 (0%) | 2/44 (4.5%) |
| Event | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| RashProduct Issues | 2/44 |
Of those enrolled in the study, 44 participants began baseline assessment.
| Age, Customized(Participants) | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| 45 to 55 | 12 |
| 46 to 65 | 26 |
| 66 to 75 | 6 |
| Over 75 | 0 |
| Declined to Respond | 0 |
| Sex: Female, Male(Participants) | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Female | 37 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention: Behavioral Change Techniques to Encourage Habit Formation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 34 |
| More than one race | 1 |
| Unknown or Not Reported | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
Supporting information: Study protocol, Sap, Icf
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