Physical InactivityNCT05273437
The JustWalk JITAI Study: A System Identification Experiment to Understand Just-in-Time States of Physical Activity
A study testing System identification experiment for physical activity in people with Physical Inactivity and Health Behavior, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this system identification experiment is to estimate and validate dynamical computational models that can be used in a future a multi-timescale model-predictive controller. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Physical Inactivity, Health Behavior, Healthy Lifestyle
- What is being tested?
- System identification experiment for physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 15 May 2023
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inactive: engaging in less than 60 min/week of self-reported moderate intensity physical activity
- adults: aged 21 or older
- own a smartphone that can run HeartSteps (iOS or Android)
Who cannot join
- not proficient in English, or
- indicate medical problems that preclude physical activity as defined using physical activity readiness questionnaire (PAR-Q)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92093
About this study
Official title: Control Systems Engineering for Counteracting Notification Fatigue: An Examination of Health Behavior Change.
The goal of this system identification experiment is to estimate and validate dynamical computational models that can be used in a future a multi-timescale model-predictive controller. System identification is an experimental approach used in control systems engineering, which uses random and pseudo-random signal designs to experimentally manipulate independent variables, with the goal of producing dynamical models that can meaningfully predict individual responses to varying provision of support. A system identification is single subject/N-of-1 experimental design, whereby each person is their own control. This 9-month system identification experiment will experimentally vary daily suggested step goals and provision of notifications meant to inspire bouts of walking during different plausible just-in-time states. Results of this system identification experiment will then enable the development a future multi-timescale model-predictive controller-driven just-in-time adaptive intervention (JITAI) intended to increase steps/day. The system identification experiment will be conducted among N=50 inactive, adults aged 21 or over who have no preexisting conditions that preclude them from engaging in an exercise program, as determined using the physical activity readiness questionnaire.
Read the detailed description
N=50 English-speaking adults aged 21+ who are physically inactive (self-reported engagement in less than 60 minutes/week of moderate-intensity activity) and own a smartphone (iPhone or Android) will be recruited. Participants will be provided with and asked to wear a Fitbit Versa 3 and use the study app, JustWalk, for 270 days.
A system identification experiment, which is a single subject/N-of-1 experimental protocol used in control systems engineering, will be conducted. This study is designed to empirically optimize dynamical models that can be used within a future model-predictive controller-driven just-in-time adaptive intervention (JITAI). This system identification experiment will include two experimentally manipulated components: 1) notifications delivered up to 4 time per day designed to increase a person's steps within the next 3 hours via either increased awareness of the urge to walk or via bout planning; and 2) adaptive daily step goal suggestions. Both components will be experimentally manipulated using procedures appropriate for system identification. Specifically, notifications prompting planning of short walks within the next 3 hours will be experimentally provided or not across variations of need (i.e., whether daily step goals were previously met), opportunity (i.e., the next three hours is a time window when a person previously walked), and receptivity (i.e., person received fewer than 6 messages in the last 72 hours and walked after notifications were sent). This enables experimental manipulation of varying "just-in-time" states, thus providing valuable data for guiding future predictions about when, where, and for whom a bout notification would produce the desired effects compared to not. Thus, this is a hypothesis-driven approach to better understanding issues of notification fatigue by seeking to provide notifications only when said notifications are needed, when a person has the opportunity to act on them, and is receptive to receiving support. In addition, suggested daily step goals will also be varied systematically across time. A suggested step goal will vary between a person's median steps/day, calculated from the person's previous activity measured via Fitbit, up to 3,000 steps above their median reference. The goals will continue to get progressively more difficult if a person meets their suggested step goals. The system will stop increasing suggested step goals if a person achieves a median of 12,000 steps/day as their reference. During the study, participants will wear a Fitbit for the duration to measure PA and also fill out ecological momentary assessment surveys of psychological constructs hypothesized to be key variables for the targeted dynamical computational models.
After study completion, dynamical modeling analyses appropriate for system identification will be conducted for each participant (see references for more details on the types of analyses that will be conducted). The goal is to estimate and validate the dynamical computational models, with a particular benchmark used on the degree to which a dynamical model can predict, prospectively, each person's future steps/day and response to a particular bout notification. Results from this dynamical systems modeling will then enable the development of a multi-timescale model-predictive controller driven JITAI designed to provide support for increasing walking among healthy adults, which can then be tested in a future clinical trial.
- Conditions
- Physical Inactivity, Health Behavior, Healthy Lifestyle
- Being tested
- System identification experiment for physical activity
- Medical subject headings
- Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System identification experiment for physical activityBehavioural
The system identification experiment in Just Walk JITAI study has two key components that are the focus of the system identification experiment: daily adaptive step goal recommendations and within-day suggestions to either plan a bout of walking or to inspire reflection and, by extension, an increased urge to go for a walk.
| Study group | Role | What they receive |
|---|---|---|
| System Identification | Experimental | All participants in the study will go through a system identification experiment everyday for 270 days. Receives: Behavioral: System identification experiment for physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps/Day
This will be measured continuously for the duration of the study via a Fitbit Versa, a wrist-worn, consumer-level activity tracker.
Measured: Everyday from baseline to the end of study (for 270 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start11 Apr 2022
- Primary completion15 May 2023
- Study completion15 May 2023
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- See study description for details. All participants will receive all intervention elements, with provision varying across time experimentally using procedures appropriate for system identification.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Eric Hekler, University of California, San Diego
- Investigators
- Eric Hekler, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273437
- Sponsor's protocol ID
- 800132
- Other IDs
- 5R01LM013107
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2022
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hekler EB, Rivera DE, Martin CA, Phatak SS, Freigoun MT, Korinek E, Klasnja P, Adams MA, Buman MP. Tutorial for Using Control Systems Engineering to Optimize Adaptive Mobile Health Interventions. J Med Internet Res. 2018 Jun 28;20(6):e214. doi: 10.2196/jmir.8622.
PubMed 29954725Phatak SS, Freigoun MT, Martin CA, Rivera DE, Korinek EV, Adams MA, Buman MP, Klasnja P, Hekler EB. Modeling individual differences: A case study of the application of system identification for personalizing a physical activity intervention. J Biomed Inform. 2018 Mar;79:82-97. doi: 10.1016/j.jbi.2018.01.010. Epub 2018 Feb 1.
PubMed 29409750Korinek EV, Phatak SS, Martin CA, Freigoun MT, Rivera DE, Adams MA, Klasnja P, Buman MP, Hekler EB. Adaptive step goals and rewards: a longitudinal growth model of daily steps for a smartphone-based walking intervention. J Behav Med. 2018 Feb;41(1):74-86. doi: 10.1007/s10865-017-9878-3. Epub 2017 Sep 16.
PubMed 28918547Park J, Kim M, El Mistiri M, Kha R, Banerjee S, Gotzian L, Chevance G, Rivera DE, Klasnja P, Hekler E. Advancing Understanding of Just-in-Time States for Supporting Physical Activity (Project JustWalk JITAI): Protocol for a System ID Study of Just-in-Time Adaptive Interventions. JMIR Res Protoc. 2023 Sep 26;12:e52161. doi: 10.2196/52161.
PubMed 37751237
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control Systems Engineering for Counteracting Notification Fatigue: An Examination of Health Behavior Change.
- ClinicalTrials.gov ID
- NCT05273437
- Acronym / sponsor ID
- 800132
- Conditions
- Physical Inactivity, Health Behavior, Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this system identification experiment is to estimate and validate dynamical computational models that can be used in a future a multi-timescale model-predictive controller. System identification is an experimental approach used in control systems engineering, which uses random and pseudo-random signal designs to experimentally manipulate independent variables, with the goal of producing dynamical models that can meaningfully predict individual responses to varying provision of support. A system identification is single subject/N-of-1 experimental design, whereby each person is their own control. This 9-month system identification experiment will experimentally vary daily suggested step goals and provision of notifications meant to inspire bouts of walking during different plausible just-in-time states. Results of this system identification experiment will then enable the development a future multi-timescale model-predictive controller-driven just-in-time adaptive intervention (JITAI) intended to increase steps/day. The system identification experiment will be conducted among N=50 inactive, adults aged 21 or over who have no preexisting conditions that preclude them from engaging in an exercise program, as determined using the physical activity readiness questionnaire.
Detailed description
N=50 English-speaking adults aged 21+ who are physically inactive (self-reported engagement in less than 60 minutes/week of moderate-intensity activity) and own a smartphone (iPhone or Android) will be recruited. Participants will be provided with and asked to wear a Fitbit Versa 3 and use the study app, JustWalk, for 270 days.
A system identification experiment, which is a single subject/N-of-1 experimental protocol used in control systems engineering, will be conducted. This study is designed to empirically optimize dynamical models that can be used within a future model-predictive controller-driven just-in-time adaptive intervention (JITAI). This system identification experiment will include two experimentally manipulated components: 1) notifications delivered up to 4 time per day designed to increase a person's steps within the next 3 hours via either increased awareness of the urge to walk or via bout planning; and 2) adaptive daily step goal suggestions. Both components will be experimentally manipulated using procedures appropriate for system identification. Specifically, notifications prompting planning of short walks within the next 3 hours will be experimentally provided or not across variations of need (i.e., whether daily step goals were previously met), opportunity (i.e., the next three hours is a time window when a person previously walked), and receptivity (i.e., person received fewer than 6 messages in the last 72 hours and walked after notifications were sent). This enables experimental manipulation of varying "just-in-time" states, thus providing valuable data for guiding future predictions about when, where, and for whom a bout notification would produce the desired effects compared to not. Thus, this is a hypothesis-driven approach to better understanding issues of notification fatigue by seeking to provide notifications only when said notifications are needed, when a person has the opportunity to act on them, and is receptive to receiving support. In addition, suggested daily step goals will also be varied systematically across time. A suggested step goal will vary between a person's median steps/day, calculated from the person's previous activity measured via Fitbit, up to 3,000 steps above their median reference. The goals will continue to get progressively more difficult if a person meets their suggested step goals. The system will stop increasing suggested step goals if a person achieves a median of 12,000 steps/day as their reference. During the study, participants will wear a Fitbit for the duration to measure PA and also fill out ecological momentary assessment surveys of psychological constructs hypothesized to be key variables for the targeted dynamical computational models.
After study completion, dynamical modeling analyses appropriate for system identification will be conducted for each participant (see references for more details on the types of analyses that will be conducted). The goal is to estimate and validate the dynamical computational models, with a particular benchmark used on the degree to which a dynamical model can predict, prospectively, each person's future steps/day and response to a particular bout notification. Results from this dynamical systems modeling will then enable the development of a multi-timescale model-predictive controller driven JITAI designed to provide support for increasing walking among healthy adults, which can then be tested in a future clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- See study description for details. All participants will receive all intervention elements, with provision varying across time experimentally using procedures appropriate for system identification.
| Arm | Type | Receives |
|---|---|---|
| System Identification | Experimental | Behavioral: System identification experiment for physical activityAll participants in the study will go through a system identification experiment everyday for 270 days. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- inactive: engaging in less than 60 min/week of self-reported moderate intensity physical activity
- adults: aged 21 or older
- own a smartphone that can run HeartSteps (iOS or Android)
Key exclusion criteria (2 listed)
- not proficient in English, or
- indicate medical problems that preclude physical activity as defined using physical activity readiness questionnaire (PAR-Q)
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 |
|---|---|---|
| System identification experiment for physical activityThe system identification experiment in Just Walk JITAI study has two key components that are the focus of the system identification experiment: daily adaptive step goal recommendations and within-day suggestions to either plan a bout of walking or to inspire reflection and, by extension, an increased urge to go for a walk. | Behavioural | System Identification |
Primary outcome
Steps/Day
Time frame: Everyday from baseline to the end of study (for 270 days)
This will be measured continuously for the duration of the study via a Fitbit Versa, a wrist-worn, consumer-level activity tracker.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29954725Hekler EB, Rivera DE, Martin CA, Phatak SS, Freigoun MT, Korinek E, Klasnja P, Adams MA, Buman MP. Tutorial for Using Control Systems Engineering to Optimize Adaptive Mobile Health Interventions. J Med Internet Res. 2018 Jun 28;20(6):e214. doi: 10.2196/jmir.8622.
- Background: PubMed 29409750Phatak SS, Freigoun MT, Martin CA, Rivera DE, Korinek EV, Adams MA, Buman MP, Klasnja P, Hekler EB. Modeling individual differences: A case study of the application of system identification for personalizing a physical activity intervention. J Biomed Inform. 2018 Mar;79:82-97. doi: 10.1016/j.jbi.2018.01.010. Epub 2018 Feb 1.
- Background: PubMed 28918547Korinek EV, Phatak SS, Martin CA, Freigoun MT, Rivera DE, Adams MA, Klasnja P, Buman MP, Hekler EB. Adaptive step goals and rewards: a longitudinal growth model of daily steps for a smartphone-based walking intervention. J Behav Med. 2018 Feb;41(1):74-86. doi: 10.1007/s10865-017-9878-3. Epub 2017 Sep 16.
- Derived from this study: PubMed 37751237Park J, Kim M, El Mistiri M, Kha R, Banerjee S, Gotzian L, Chevance G, Rivera DE, Klasnja P, Hekler E. Advancing Understanding of Just-in-Time States for Supporting Physical Activity (Project JustWalk JITAI): Protocol for a System ID Study of Just-in-Time Adaptive Interventions. JMIR Res Protoc. 2023 Sep 26;12:e52161. doi: 10.2196/52161.
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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.
Eric Hekler, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing System identification experiment for physical activity in people with Physical Inactivity and Health Behavior, run by University of California, San Diego 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 3 inclusion and 2 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 19 Nov 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2024). 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?
Steps/Day (time frame: Everyday from baseline to the end of study (for 270 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273437, which also lists 4 linked publications.
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 19 Nov 2024.