NCT05273437

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

February 22, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

February 22, 2022

Results QC Date

August 30, 2024

Last Update Submit

October 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Steps/Day

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

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

Study Arms (1)

System Identification

EXPERIMENTAL

All participants in the study will go through a system identification experiment everyday for 270 days.

Behavioral: System identification experiment for physical activity

Interventions

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.

System Identification

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

Related Publications (4)

  • 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.

    PMID: 29954725BACKGROUND
  • Phatak 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.

    PMID: 29409750BACKGROUND
  • Korinek 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.

    PMID: 28918547BACKGROUND
  • Park 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.

MeSH Terms

Conditions

Sedentary BehaviorHealth Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Eric Hekler
Organization
University of California San Diego

Study Officials

  • Eric Hekler, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: See study description for details. All participants will receive all intervention elements, with provision varying across time experimentally using procedures appropriate for system identification.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 10, 2022

Study Start

April 11, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

November 19, 2024

Results First Posted

November 19, 2024

Record last verified: 2024-10

Locations