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L'essai clinique NCT05598996 (YourMove) pour Inactivité physique, Comportement sédentaire est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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The YourMove Study: Optimizing Individualized and Adaptive mHealth Interventions Via Control Systems Engineering Methods

Actif, pas en recrutement
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L'étude clinique NCT05598996 (YourMove) est un essai interventionnel pour Inactivité physique, Comportement sédentaire. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 7 octobre 2022 et vise à recruter 386 participants. Dirigé par l'Université de Californie à San Diego, l'essai devrait être terminé d'ici le 9 août 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 août 2024.
Résumé succinct
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 détaillée
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.

Titre officiel

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

Conditions
Inactivité physiqueComportement sédentaire
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
Numéro NCT
NCT05598996
Date de début (réel)
2022-10-07
Dernière mise à jour publiée
2024-08-15
Date de fin (estimée)
2025-08-09
Inscription (estimée)
386
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Mots clés
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
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalCOT-Based Intervention
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.
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.
Aucune interventionControl
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).
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Change in minutes of moderate-to-vigorous physical activity (MVPA)
Measured using a waist-worn tri-axial accelerometer for 7-days
Baseline, 12-months
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Change in weight
Objectively measured weight in kilograms.
Baseline, 12-months
Change in Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m\^2.
Baseline, 12-months
Change in waist circumference
Weight and height will be combined to report BMI in kg/m\^2.
Baseline, 12-months
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
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
Change in basal metabolic rate
Measured with Bioelectric Impedance Analysis (BIA).
Baseline, 12 months
Change in systolic blood pressure
Systolic blood pressure in mmHg.
Baseline, 12 months
Change in diastolic blood pressure
Diastolic blood pressure in mmHg.
Baseline, 12 months
Change in flexibility
Sit and reach test.
Baseline, 12 months
Change in grip strength
Grip strength of the right and left hands in kilograms with a dynamometer.
Baseline, 12 months
Physical activity
Measured using Fitbit.
Through study completion, up to 12 months
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
Sleep
Measured using Fitbit.
Through study completion, up to 12 months
Resting heart rate
Measured using Fitbit.
Through study completion, up to 12 months
Sedentary Behavior
Measured using Fitbit.
Through study completion, up to 12 months
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
Change in resting heart rate
Measured by research assistant.
Baseline, 12 months
Sedentary Behavior
Measured using a waist-worn tri-axial accelerometer.
Baseline, 12 months
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
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
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
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
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
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
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
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
Change in Gait Speed
Measured using the 25-ft walk test
Baseline, 12 months
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
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
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
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
25 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • 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

  • 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
University of California, San Diego logoUniversité de Californie à San Diego339 essais cliniques actifs à explorer
Partie responsable de l'essai
Eric Hekler, Investigateur principal, Professor, University of California, San Diego
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays

California

University of California San Diego, San Diego, California, 92093, United States