Sedentary BehaviorPhase 1NCT04869644
A Trial of Habit Formation Theory for Exercise in Older Adults
A Phase 1 study testing Goal setting, Action Planning and Self-monitoring of behavior in people with Sedentary Behavior and Aging, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Aging, Activity, Motor
- What is being tested?
- Goal setting, Action Planning and Self-monitoring of behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 31 May 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Personalized Health
New York, New York, 10022
About this study
Official title: A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
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.
Read the 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.
- Conditions
- Sedentary Behavior, Aging, Activity, Motor, Behavior, Health
- Being tested
- Goal setting, Action Planning, Self-monitoring of behavior, Behavioral Practice/Rehearsal, Habit Formation
- Keywords
- Habit Formation, Physical Activity, Behavior Change, Virtual, Personalized Trial, Personalized, Feasibility
- Medical subject headings
- Sedentary Behavior, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal settingBehavioural
Goal setting: set or agree on a goal defined in terms of behavior to be achieved.
Action PlanningBehavioural
Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity.
Self-monitoring of behaviorBehavioural
Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.
Behavioral Practice/RehearsalBehavioural
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.
Habit FormationBehavioural
Prompt rehearsal \& repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Goal setting; Behavioral: Action Planning; Behavioral: Self-monitoring of behavior; Behavioral: Behavioral Practice/Rehearsal; Behavioral: Habit Formation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed once after completion of the study at 12 weeks.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start26 Mar 2021
- Primary completion1 Feb 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Columbia University
- Responsible party
- Principal investigator, Karina Davidson, Northwell Health
- Investigators
- Karina W Davidson, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869644
- Sponsor's protocol ID
- 20-1182
- Other IDs
- P30AG063786-01
- Status last verified
- Nov 2022
- First submitted
- 18 Apr 2021
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT04869644
- Acronym / sponsor ID
- 20-1182
- Conditions
- Sedentary Behavior, Aging, Activity, Motor, Behavior, Health
- Keywords
- Habit Formation, Physical Activity, Behavior Change, Virtual, Personalized Trial, Personalized, Feasibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Columbia University
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Behavioral Change Techniques to encourage Habit Formation | Experimental | Behavioral: Goal setting, Behavioral: Action Planning, Behavioral: Self-monitoring of behavior, Behavioral: Behavioral Practice/Rehearsal, Behavioral: Habit FormationIndividuals 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal settingGoal setting: set or agree on a goal defined in terms of behavior to be achieved. | Behavioural | Intervention: Behavioral Change Techniques to encourage Habit Formation |
| Action PlanningAction planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity. | Behavioural | Intervention: Behavioral Change Techniques to encourage Habit Formation |
| Self-monitoring of behaviorSelf-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit. | Behavioural | Intervention: Behavioral Change Techniques to encourage Habit Formation |
| Behavioral Practice/RehearsalBehavioral 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. | Behavioural | Intervention: Behavioral Change Techniques to encourage Habit Formation |
| Habit FormationPrompt rehearsal \& repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior. | Behavioural | Intervention: Behavioral Change Techniques to encourage Habit Formation |
Primary outcome
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. 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.
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 "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.
4 secondary outcomes
Within-person Change in Daily Steps.
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.
Time frame: Assessed once after completion of the study at 12 weeks.
Participant Attitudes and Opinions Towards Personalized Trials.
Time frame: Assessed once after the completion of the intervention period.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina W Davidson principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Goal setting, Action Planning and Self-monitoring of behavior in people with Sedentary Behavior and Aging, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.