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

Sedentary Behavior Clinical Trial

— YourMove  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598996
• Other study ID #: 20733
• Secondary ID: 1R01CA244777-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: Michael Higgins, MS
• Phone: 858-356-2849
• Email: yourmove[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of care corporate wellness program.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• COT-Based Intervention
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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	Arizona State University, National Cancer Institute (NCI), Small Steps Labs, LLC, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking & Marijuana Use	Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 26 items related to their smoking and marijuana use over the past 6 months.	Baseline, 12 months
Other	Alcohol Use	Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 10 items related to their alcohol use over the past 6 months.	Baseline, 12 months
Primary	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	Change in weight	Objectively measured weight in kilograms.	Baseline, 12-months
Secondary	Change in Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Baseline, 12-months
Secondary	Change in waist circumference	Weight and height will be combined to report BMI in kg/m^2.	Baseline, 12-months
Secondary	Change in waist-to-hip ratio	Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm.	Baseline, 12 months
Secondary	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).	Baseline, 12 months
Secondary	Change in basal metabolic rate	Measured with Bioelectric Impedance Analysis (BIA).	Baseline, 12 months
Secondary	Change in systolic blood pressure	Systolic blood pressure in mmHg.	Baseline, 12 months
Secondary	Change in diastolic blood pressure	Diastolic blood pressure in mmHg.	Baseline, 12 months
Secondary	Change in flexibility	Sit and reach test.	Baseline, 12 months
Secondary	Change in grip strength	Grip strength of the right and left hands in kilograms with a dynamometer.	Baseline, 12 months
Secondary	Physical activity	Measured using Fitbit.	Through study completion, up to 12 months
Secondary	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.	Baseline, 12 months
Secondary	Sleep	Measured using Fitbit.	Through study completion, up to 12 months
Secondary	Resting heart rate	Measured using Fitbit.	Through study completion, up to 12 months
Secondary	Sedentary Behavior	Measured using Fitbit.	Through study completion, up to 12 months
Secondary	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.	Baseline, 12 months
Secondary	Change in resting heart rate	Measured by research assistant.	Baseline, 12 months
Secondary	Sedentary Behavior	Measured using a waist-worn tri-axial accelerometer.	Baseline, 12 months
Secondary	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".	Baseline, 12 months
Secondary	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".	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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".	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	Change in Gait Speed	Measured using the 25-ft walk test	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months