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Inactivity, PhysicalYourMoveNCT05598996

The YourMove Study: Optimizing Individualized and Adaptive mHealth Interventions Via Control Systems Engineering Methods

A study testing COT-Based Intervention in people with Inactivity, Physical and Sedentary Behavior, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of a new digital health tool that uses a phone and smartwatch to encourage physical activity and increase weekly amounts of Moderate to Vigorous Physical Activity (MVPA) over 12 months among adults compared to a digital health intervention that mimics a standard… Read more about this study

Who is it for?
Ages 25 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Inactivity, Physical, Sedentary Behavior
What is being tested?
COT-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
1 siteUnited States
Study dates
7 Oct 2022to 8 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 25 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 25-80 years old
  • Intend to be available for a 12-month intervention
  • Willing and able to attend 3 measurement visits over 12-months
  • Willing and able to use a smartphone and text messaging
  • Willing and able to use the wearable and corresponding app
  • Willing and able to walk and engage in moderate-intensity physical activity
  • Healthy enough to participate based on the Physical Activity Readiness Questionnaire
  • BMI between 18-40 kg/m^2

Who cannot join

  • Psychiatric or medical conditions that prohibit compliance with the study protocol
  • Enrolled in or planning to enroll in a physical activity program during the study period
  • Those with a mechanical medical implant, such as a pacemaker

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Diego

    San Diego, California, 92093

Other trials in United States

About this study

The purpose of this study is to determine the efficacy of a new digital health tool that uses a phone and smartwatch to encourage physical activity and increase weekly amounts of Moderate to Vigorous Physical Activity (MVPA) over 12 months among adults compared to a digital health intervention that mimics a standard of care corporate wellness program.

Read the detailed description

Strong evidence indicates physical activity (PA) reduces risk of bladder, breast, colon, endometrium, esophagus, gastric, and renal cancer, and there is moderate evidence for lung cancer. Individuals aged 25+ who are inactive are at high risk of developing a variety of cancers. Unfortunately, only 1/3 of adults meet guidelines for PA; thus, they are an important group to target. In response, the investigators developed JustWalk, a modular adaptive mobile health (mHealth) intervention that makes daily N-of-1 adjustments to support PA for each person. JustWalk can perform N-of-1 adaptation based on our innovative use of control engineering methods, which the investigators call a control optimization trial (COT).

The YourMove study is a 12-month 2-arm randomized control trial (RCT) designed to assess the efficacy of COT methods in 386 adults aged 25+ who are inactive. The investigators will evaluate the differences in minutes/week of moderate-to-vigorous intensity PA (MVPA), measured via accelerometers, among the COT-optimized (intervention) vs. non-COT intervention designed in accordance with standard of care digital corporate wellness to support physical activity (control) groups at 12 months.

The YourMove Study uses a fully integrated system of modalities that include: 1) a popular consumer-level wearable (e.g., Fitbit Versa) and corresponding app (e.g., the Fitbit app); 2) daily process-level analyses done using the Fitbit Versa and ecological momentary assessment (EMA) measures rooted in social cognitive theory (SCT) constructs to promote behavior change; 3) a highly tailored text messaging system encouraging participants to achieve recommended minutes of physical activity: >150 minutes per week of moderate-to-vigorous physical activity (MVPA); and 4) a self-study tool called "Reflect", which is meant to support individuals in self-experimentation to identify strategies that work for them to fit regular MVPA into their lives. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. A variety of self-reported measures asked daily via EMA enables the measurement of psychosocial factors important for the development of a dynamical SCT model and produces ambitious yet achievable step goals that are adaptive to each individual. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 150 min/week of MVPA.

Being tested
COT-Based Intervention
Keywords
technology, physical activity, resilience, wearable, mobile application, behavior mechanism, behavior, intervention, text message, ecological momentary assessment, reflection, inactivity, exercise, walking, sedentary, Fitbit, smartwatch, notifications, wellness, EMA
Medical subject headings
Sedentary Behavior, Motor Activity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COT-Based InterventionBehavioural

    The COT-based approach uses a controller that runs case-by-case dynamical systems simulations modeling based on answers to daily questions rooted in social cognitive theory to produce ambitious but achievable daily adaptive step goal recommendations. The process for the COT-based approach is as follows: Phase 1) 2-week measurement only; Phase 2) open-loop system identification experiment (meant to create individualized dynamical models for each participant); Phase 3) closed-loop experiment to optimize for PA initiation, and Phase 4) closed-loop experiment to optimize for PA maintenance.

Study groups in NCT05598996
Study groupRoleWhat they receive
COT-Based InterventionExperimentalThe COT-based intervention will include the following to improve both steps/day (move more), and improving minutes/week of MVPA (exercise): adaptive daily steps/day goal-setting plus feedback; positive reinforcement (i.e., points, which translate to gift cards), self-monitoring of both steps/day and min/week MVPA; education about MVPA sent via text message in both conditions; planning support for scheduling bouts of MVPA via SMS in both conditions; and motivational messages sent via SMS in both conditions, and the use of a self-experimentation tool (REFLECT), developed based on prior successful pilot efforts, focused on fostering effective self-regulatory capacities of individuals.
Receives: Behavioral: COT-Based Intervention
ControlNo interventionThe non-COT approach was designed to be an equivalent to emerging standard of care options for digital health worksite wellness programs to increase PA (control) for a 12-month study period. Participants assigned to the non-COT-based (control) group will receive the latest Fitbit Versa smartwatch and will download the Fitbit smartphone app. Unlike the intervention group, the daily step goal and the accompanying number of points will be static (10,000 steps/day; 150 points/day, respectively). The goal will be delivered to participants via the standard Fitbit app features and points will be communicated via email. Participants will also receive a weekly PA goal (150 minutes of MVPA/per week) and the same accompanying motivational and informative texts that the intervention group receives. Control participants will not complete the physical activity and exercise reflection and planning exercise (Reflect).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in minutes of moderate-to-vigorous physical activity (MVPA)

    Measured using a waist-worn tri-axial accelerometer for 7-days

    Measured: Baseline, 12-months

Secondary outcomes (31)
  1. Change in weight

    Objectively measured weight in kilograms.

    Measured: Baseline, 12-months

  2. Change in Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: Baseline, 12-months

  3. Change in waist circumference

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: Baseline, 12-months

  4. Change in waist-to-hip ratio

    Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm.

    Measured: Baseline, 12 months

  5. Change in body composition

    Total body body composition (fat mass, including a rating of visceral adipose tissue, lean mass, and body water) measured with Bioelectric Impedance Analysis (BIA).

    Measured: Baseline, 12 months

  6. Change in basal metabolic rate

    Measured with Bioelectric Impedance Analysis (BIA).

    Measured: Baseline, 12 months

  7. Change in systolic blood pressure

    Systolic blood pressure in mmHg.

    Measured: Baseline, 12 months

  8. Change in diastolic blood pressure

    Diastolic blood pressure in mmHg.

    Measured: Baseline, 12 months

  9. Change in flexibility

    Sit and reach test.

    Measured: Baseline, 12 months

  10. Change in grip strength

    Grip strength of the right and left hands in kilograms with a dynamometer.

    Measured: Baseline, 12 months

  11. Physical activity

    Measured using Fitbit.

    Measured: Through study completion, up to 12 months

  12. Change in physical activity

    Assessed through self-report using the Global Physical Activity Questionnaire. The questionnaire is comprised of 16 questions related to physical activity in three settings that include activity at work, travel to and from places, and recreational activities, in addition to sedentary behavior. Metabolic Equivalent (MET) values are assigned to time variables according to intensity of activity, moderate or vigorous, reported in each of the settings. MET values are then used to calculate total physical activity.

    Measured: Baseline, 12 months

  13. Sleep

    Measured using Fitbit.

    Measured: Through study completion, up to 12 months

  14. Resting heart rate

    Measured using Fitbit.

    Measured: Through study completion, up to 12 months

  15. Sedentary Behavior

    Measured using Fitbit.

    Measured: Through study completion, up to 12 months

  16. Change in sleep

    Assessed through self-report using a modified Pittsburg Sleep Quality Index questionnaire. Participants respond to questions related to sleep duration and how often they have difficulty falling asleep and staying awake, do not get enough rest. A higher score indicates more restful sleep.

    Measured: Baseline, 12 months

  17. Change in resting heart rate

    Measured by research assistant.

    Measured: Baseline, 12 months

  18. Sedentary Behavior

    Measured using a waist-worn tri-axial accelerometer.

    Measured: Baseline, 12 months

  19. Change in sedentary Behavior

    Assessed using the Last 7 Day Sedentary Behavior Questionnaire (SIT-Q-7d), which assesses sitting or lying down in five domains (meals, transportation, occupation, non-occupational screen time, and other sedentary time), thus facilitating the calculation of domain-specific and total sedentary time. Frequency within the last 30 days is assessed on a 5-point response scale, ranging from "never or hardly ever" to "always or almost always".

    Measured: Baseline, 12 months

  20. Physical Activity: Change Strategies

    Physical Activity: Change Strategies survey consists of 15-items that assess how often participants engage in strategies that help them change their physical activity in the past month using a 5-point response scale ranging from "Never" to "Many times".

    Measured: Baseline, 12 months

  21. Physical Activity Neighborhood Environment

    Physical Activity Neighborhood Environment survey consists of 17-items that assess the environmental factors for walking and bicycling in various neighborhoods. Higher values from the scale indicate greater environmental support for physical activity.

    Measured: Baseline, 12 months

  22. Social Support for Physical Activity

    Assessed using the Physical Activity and Social Support Scale which consists of 20-items scale based in five forms of social support - companionship, emotional, instrumental, informational, and validation for physical activity. Participants respond to items on a 7-point Likert scale ranging from "never" to "always", or "not applicable". A higher score indicates individuals who are seeking to change exercise behaviors feel a high level of support from friends and family.

    Measured: Baseline, 12 months

  23. Depression

    Assessed using the Center for Epidemiologic Studies depression scale which consists of 10-items. Participants respond to items related to how they feel and behave on a 5-point response scale ranging from "Rarely or none of the time" to "All of the time". A score equal to or above 10 is considered depressed.

    Measured: Baseline, 12 months

  24. Anxiety

    Assessed using the short-form of the state scale of the Spielberger State Trait Anxiety Inventory which consists of 6 items. Participants respond to items related to how they feel on a 4-point response scale ranging from "Not at all" to "Very much".

    Measured: Baseline, 12 months

  25. Self-esteem

    Assessed using the Rosenberg Self-esteem Scale which consists of 10-items. Participants respond to items related to items related to global self-worth on a 4-point Likert scale ranging from "strongly agree" to "strongly disagree". Higher scores indicate higher self-esteem.

    Measured: Baseline, 12 months

  26. Quality of Well-being

    Assessed using the Quality of Well-being survey, self-administered version which consists of 71 items. Participants respond to items related to health status and overall well-being over the previous 3 days. Scores are translated to quality-adjusted life years.

    Measured: Baseline, 12 months

  27. Change in Gait Speed

    Measured using the 25-ft walk test

    Measured: Baseline, 12 months

  28. Change lower extremity functional strength

    Measured using 5x sit-to-stand test which has participants stand up and sit down as quickly as possible 5 times from a straight-backed chair. Only assessed in participants 50 and older.

    Measured: Baseline, 12 months

  29. Change in balance

    Assessed with feet in three different positions for 20 seconds each position (feet side by side, feet semi-tandem, and feet full-tandem). All balance testing will be measured using BtrackS balance tracking system, a computerized force plate that will provide a more objective and detailed assessment of balance than administrator observation alone, including total sway measured in centimeters. Only assessed in participants 50 and older.

    Measured: Baseline, 12 months

  30. Change in timed-up-and-go (TUG)

    Participants will be instructed to stand up from a chair, walk around a cone set up 10 feet away, and return to sit in the chair. Only assessed in participants 50 and older.

    Measured: Baseline, 12 months

  31. Change in aerobic fitness

    Assessed using a sub-maximal graded exercise test. A treadmill walking protocol at a participant-selected speed with elevation increases every 2 minutes will be employed until the participant reaches 85% of age predicted maximal heart rate (220 bpm - age) or volitional fatigue, whichever occurs first.

    Measured: Baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start7 Oct 2022
  3. Primary completion8 Nov 2025
  4. Study completion8 Nov 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
The study is a 12-month parallel-group randomized controlled trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598996
Sponsor's protocol ID
20733
Other IDs
1R01CA244777-01A1
Acronym
YourMove
Status last verified
Feb 2026
First submitted
21 Oct 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim M, Mansour-Assi S, El Mistiri M, Park J, Banerjee S, Khan O, De La Torre S, Higgins M, Godino J, Patrick K, Nebeker C, Jain S, Klasnja P, E Rivera D, Hekler E. Optimizing and Testing an Individualized and Adaptive Physical Activity Digital Health Intervention: Protocol for a Control Optimization Trial Embedded Within a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 15;14:e70599. doi: 10.2196/70599.

    PubMed 40815836
  • Mistiri ME, Khan O, Martin CA, Hekler E, Rivera DE. Data-Driven Mobile Health: System Identification and Hybrid Model Predictive Control to Deliver Personalized Physical Activity Interventions. IEEE Open J Control Syst. 2025;4:83-102. doi: 10.1109/ojcsys.2025.3538263. Epub 2025 Feb 4.

    PubMed 40626117

Questions about this trial

What is this clinical trial studying?

A study testing COT-Based Intervention in people with Inactivity, Physical and Sedentary 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 8 inclusion and 3 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 13 Feb 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 minutes of moderate-to-vigorous physical activity (MVPA) (time frame: Baseline, 12-months). 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 NCT05598996, which also lists 2 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 13 Feb 2026.

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