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임상시험 NCT05598996 (YourMove)은(는) 신체 활동 부족, 좌식 행동에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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The YourMove Study: Optimizing Individualized and Adaptive mHealth Interventions Via Control Systems Engineering Methods

진행중, 모집종료
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임상시험 NCT05598996 (YourMove)은(는) 신체 활동 부족, 좌식 행동에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2022년 10월 7일에 시작되어 386명의 참여자를 모집하고 있습니다. 캘리포니아 대학교 샌디에이고이(가) 진행하며, 2025년 8월 9일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 8월 15일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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.

공식 제목

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

질환/상태
신체 활동 부족좌식 행동
출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
NCT 번호
NCT05598996
실제 연구 시작일
2022-10-07
최신 업데이트 게시
2024-08-15
예상 연구 완료일
2025-08-09
계획된 등록 인원
386
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
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
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적COT-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.
비개입Control
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).
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
Change in minutes of moderate-to-vigorous physical activity (MVPA)
Measured using a waist-worn tri-axial accelerometer for 7-days
Baseline, 12-months
이차결과변수
결과변수측정값 설명시간 범위
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
적격성 기준

연령대
성인, 노인
최소 연령
25 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
  • 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 logo캘리포니아 대학교 샌디에이고339개의 진행 중인 임상시험 탐색 가능
연구 책임자
Eric Hekler, 책임연구자, Professor, University of California, San Diego
연락처 정보가 없습니다.
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California

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