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The JustWalk JITAI Study: A System Identification Experiment to Understand Just-in-Time States of Physical Activity

Control Systems Engineering for Counteracting Notification Fatigue: An Examination of Health Behavior Change.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05273437
Enrollment
50
Registered
2022-03-10
Start date
2022-04-11
Completion date
2023-05-15
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Healthy Lifestyle, Physical Inactivity

Brief 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. 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.

Interventions

BEHAVIORALSystem identification experiment for physical activity

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.

Sponsors

National Library of Medicine (NLM)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* not proficient in English, or * indicate medical problems that preclude physical activity as defined using physical activity readiness questionnaire (PAR-Q)

Design outcomes

Primary

MeasureTime frameDescription
Steps/DayEveryday 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
System Identification
All participants in the study will go through a system identification experiment everyday for 270 days. System identification experiment for physical activity: The system identification experiment in Just Walk JITAI study has two key components that are the focus of the system identification experiment: walking suggestions and daily step goals. To achieve the desired dynamics on the timescale of interest, we used 2 input signals, one for each of the 2 components. Although our study design enables traditional statistical analyses to examine the impact of intervention components on behavioral outcomes, that is not the primary focus of a system ID experiment. The primary goal of a system ID experiment is to estimate and validate dynamical computational models that are validated based on their ability to predict the future responses of each individual's behavior across time. These aims are achieved by having different intervention components-suggestions to walk in the next 3 hours and adaptive goal setting-delivered at different timescales and orthogonally, that is, statistically independent of each other.
48
Total48

Baseline characteristics

CharacteristicSystem Identification
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
48 Participants
Age, Continuous38.4 years
STANDARD_DEVIATION 9.3
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
14 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
17 Participants
Region of Enrollment
United States
48 participants
Sex: Female, Male
Female
29 Participants
Sex: Female, Male
Male
16 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 50
other
Total, other adverse events
0 / 50
serious
Total, serious adverse events
0 / 50

Outcome results

Primary

Steps/Day

This will be measured continuously for the duration of the study via a Fitbit Versa, a wrist-worn, consumer-level activity tracker.

Time frame: Everyday from baseline to the end of study (for 270 days)

ArmMeasureGroupValue (NUMBER)
System IdentificationSteps/DayParticipant 6NA Steps/day
System IdentificationSteps/DayParticipant 71254.6 Steps/day
System IdentificationSteps/DayParticipant 82168.3 Steps/day
System IdentificationSteps/DayParticipant 91471.5 Steps/day
System IdentificationSteps/DayParticipant 102003.8 Steps/day
System IdentificationSteps/DayParticipant 11NA Steps/day
System IdentificationSteps/DayParticipant 121333.0 Steps/day
System IdentificationSteps/DayParticipant 131168.5 Steps/day
System IdentificationSteps/DayParticipant 142577.2 Steps/day
System IdentificationSteps/DayParticipant 152703.3 Steps/day
System IdentificationSteps/DayParticipant 161819.4 Steps/day
System IdentificationSteps/DayParticipant 171930.3 Steps/day
System IdentificationSteps/DayParticipant 182229.0 Steps/day
System IdentificationSteps/DayParticipant 19295.0 Steps/day
System IdentificationSteps/DayParticipant 201887.8 Steps/day
System IdentificationSteps/DayParticipant 211563.3 Steps/day
System IdentificationSteps/DayParticipant 22704.9 Steps/day
System IdentificationSteps/DayParticipant 231703.3 Steps/day
System IdentificationSteps/DayParticipant 24156.4 Steps/day
System IdentificationSteps/DayParticipant 251187.5 Steps/day
System IdentificationSteps/DayParticipant 263697.9 Steps/day
System IdentificationSteps/DayParticipant 271138.1 Steps/day
System IdentificationSteps/DayParticipant 281470.2 Steps/day
System IdentificationSteps/DayParticipant 29919.0 Steps/day
System IdentificationSteps/DayParticipant 30NA Steps/day
System IdentificationSteps/DayParticipant 311015.9 Steps/day
System IdentificationSteps/DayParticipant 32NA Steps/day
System IdentificationSteps/DayParticipant 33449.8 Steps/day
System IdentificationSteps/DayParticipant 341228.2 Steps/day
System IdentificationSteps/DayParticipant 351074.1 Steps/day
System IdentificationSteps/DayParticipant 36967.1 Steps/day
System IdentificationSteps/DayParticipant 372928.6 Steps/day
System IdentificationSteps/DayParticipant 382608.3 Steps/day
System IdentificationSteps/DayParticipant 39738.2 Steps/day
System IdentificationSteps/DayParticipant 402677.5 Steps/day
System IdentificationSteps/DayParticipant 41783.5 Steps/day
System IdentificationSteps/DayParticipant 421631.8 Steps/day
System IdentificationSteps/DayParticipant 431387.4 Steps/day
System IdentificationSteps/DayParticipant 441008.3 Steps/day
System IdentificationSteps/DayParticipant 14048.4 Steps/day
System IdentificationSteps/DayParticipant 21074.4 Steps/day
System IdentificationSteps/DayParticipant 31645.8 Steps/day
System IdentificationSteps/DayParticipant 41749.1 Steps/day
System IdentificationSteps/DayParticipant 52991.3 Steps/day
Comparison: We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.Bayesian Regression

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026