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

NCT05598996 | Completed

• 2 other identifiers: 207331R01CA244777-01A1
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief 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 of care corporate wellness program.

Conditions

Inactivity, Physical; Sedentary Behavior

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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, 12-months

Secondary Outcomes (31)

• Change in weight

  Baseline, 12-months

• Change in Body Mass Index (BMI)

  Baseline, 12-months

• Change in waist circumference

  Baseline, 12-months

• Change in waist-to-hip ratio

  Baseline, 12 months

• Change in body composition

  Baseline, 12 months

Other Outcomes (2)

• Smoking & Marijuana Use

  Baseline, 12 months

• Alcohol Use

  Baseline, 12 months

Study Arms (2)

COT-Based Intervention

EXPERIMENTAL

The 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.

Behavioral: COT-Based Intervention

Control

NO INTERVENTION

The 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).

Interventions

COT-Based Intervention BEHAVIORAL

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.

COT-Based Intervention

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Arizona State University: collaborator
• University of Michigan: collaborator
• National Cancer Institute (NCI): collaborator
• Small Steps Labs, LLC: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

Related Publications (2)

• 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.

  PMID: 40815836 DERIVED

• 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.

  PMID: 40626117 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Behavior

Study Officials

• Eric Hekler, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Daniel Rivera, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is a 12-month parallel-group randomized controlled trial.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 31, 2022
• Study Start: October 7, 2022
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)