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임상시험 NCT06597890은(는) 신체 비활동, 좌식 행동, 수면 부족, 심리적 웰빙에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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카드 뷰

Move@NUS: a Digital Intervention Cohort Promoting Healthy Movement Behaviours

대상자모집전
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임상시험 NCT06597890은(는) 신체 비활동, 좌식 행동, 수면 부족, 심리적 웰빙에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2024년 9월 9일부터 참여 신청이 가능합니다. 150명의 참여자를 모집할 예정입니다. National University of Singapore이(가) 진행하는 이 연구는 2025년 2월 28일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 9월 19일에 갱신되었습니다.
간단한 개요

The aim of the Move@NUS pilot study is to determine the feasibility of establishing a digital intervention cohort to monitor and improve the health and wellbeing of students by encouraging them to engage in healthy movement behaviours (i.e., physical activity, sleep, and limiting smartphone-based recreational screentime).

The digital intervention cohort consists of:

  • 6-months of continuous monitoring of movement behaviours, wellbeing and related factors via an Apple Watch and repeated bursts of ecological momentary assessments (EMAs).
  • 3x embedded randomised controlled trials (RCTs) evaluating the efficacy of small-scale smartphone-based interventions designed to nudge participants toward participating in healthier movement behaviours.
상세한 설명
Good overall mental and physical health and wellbeing can be promoted by engaging in healthy movement behaviours - getting adequate sleep, being physically active, and minimising recreational time spent watching a screen or being sedentary. The objectives of this study are to determine the feasibility of:

  • establishing a digital cohort study and continuously monitoring health behaviours and wellbeing (and related factors) for 6 months, and
  • rapidly evaluating the effects of ecological momentary interventions (EMIs; small-scale interventions that provide support in real-time, delivered via the smartwatch and app) for promoting healthy movement behaviours via a series of embedded RCTs.

The investigators will enrol up to 150 first-year university students into an innovative hybrid study that combines a digital cohort with embedded randomised controlled trials (RCTs). The digital cohort consists of 6 months of continuous observations of movement behaviours, wellbeing, and related factors via a smartwatch (Apple Watch) and repeated bursts of smartphone-based ecological momentary assessment (EMA) surveys. Throughout the 6-month monitoring period, participants are enrolled in 3 embedded RCTs evaluating the effects of EMIs that, in turn, target sleep, physical activity, and smartphone-based recreational screentime. For each embedded-RCT we assess engagement and acceptability outcomes (e.g., whether a push notification is opened, whether it is responded to), and preliminary efficacy (i.e., whether there is a between group difference in the target behaviour from pre- to post-intervention). Participants also complete traditional questionnaires at baseline, 3-, and 6-month follow-up.

공식 제목

Move@NUS: Pilot Study of a Digital Intervention Cohort to Promote Healthy Sleep, Screen Viewing, and Physical Activity Habits for Improved Health and Wellbeing

질환/상태
신체 비활동좌식 행동수면 부족심리적 웰빙
기타 연구 식별자
  • NUS-IRB-2023-800
NCT 번호
실제 연구 시작일
2024-09-09
최신 업데이트 게시
2024-09-19
예상 연구 완료일
2025-02-28
계획된 등록 인원
150
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
smartphone
smartwatch
Apple Watch
ecological momentary assessment (EMA)
ecological momentary intervention (EMI)
mhealth
digital health
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적RCT 1 - group 1
Sleep Hygiene Ecological Momentary Intervention (EMI)
Educational Content (Sleep Hygiene)
app-based sleep hygiene-related educational content
Sleep Hygiene Strategies
app-based self-selection of sleep hygiene strategies
알림
daily reminders sent via push notifications
Review of Behavioural Goal
app-based review of behavioural goal
목표 설정
prompt participant to set a goal in relation to targeted behaviour
실험적RCT 1 - group 2
Personalised Sleep Guideline EMI
알림
daily reminders sent via push notifications
Review of Behavioural Goal
app-based review of behavioural goal
Educational Content (Sleep Guidelines)
app-based educational content on recommended sleep guidelines
Comparison of Current Behaviour to Ideal Behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
목표 설정
prompt participant to set a goal in relation to targeted behaviour
비개입RCT 1 - group 3
Control
해당 없음
실험적RCT 2 - group 1
Stair Climbing EMI
알림
daily reminders sent via push notifications
Review of Behavioural Goal
app-based review of behavioural goal
Comparison of Current Behaviour to Ideal Behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
목표 설정
prompt participant to set a goal in relation to targeted behaviour
실험적RCT 2 - group 2
Vigorous Intermittent Lifestyle Physical Activity (VILPA) EMI
알림
daily reminders sent via push notifications
Review of Behavioural Goal
app-based review of behavioural goal
목표 설정
prompt participant to set a goal in relation to targeted behaviour
Educational Content (Vigorous Intermittent Lifestyle Physical Activity (VILPA))
app-based educational content on VILPA
비개입RCT 2 - group 3
Control
해당 없음
실험적RCT 3 - group 1
Screentime Breaktime EMI
Review of Behavioural Goal
app-based review of behavioural goal
Comparison of Current Behaviour to Ideal Behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
Screentime Breaks
repeated daily reminders to break up screentime
실험적RCT 3 - group 2
Screentime Goal EMI
알림
daily reminders sent via push notifications
Review of Behavioural Goal
app-based review of behavioural goal
Comparison of Current Behaviour to Ideal Behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
목표 설정
prompt participant to set a goal in relation to targeted behaviour
비개입RCT 3 - group 3
Control
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
RCT 1. Sleep
Sleep duration, as assessed via Apple Watch
week 1 (pre-intervention), week 3 (intervention midpoint), week 5 (post-intervention), and continuously throughout the 6-month study
RCT 2. Physical activity
Step counts, as assessed via Apple Watch
week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
RCT 2. Physical activity
Flights of stairs climbed, as assessed via Apple Watch
week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
RCT 2. Physical activity
Moderate-to-vigorous physical activity, as assessed via Apple Watch
week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
RCT 3. Screentime
Screenshots of passively captured smartphone screentime data
week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
Wellbeing
Mental wellbeing, WHO-5 Well-Being Index (WHO-5; World Health Organisation). Min value 0, max value 100; higher scores indicate greater wellbeing.
Continuously over 6-months
적격성 기준

Participants are eligible to join the study if they:

  • are enrolled in the first year of an undergraduate degree at the National University of Singapore,
  • own or use an Apple smartphone with a data plan,
  • are willing to download and use a smartphone app, and
  • have an Apple smartwatch (Series 6/SE or newer) and are willing to wear it continuously for the 6-month study duration.

Participants will be excluded if they are:

  • pregnant, or
  • planning to be overseas for more than 6 weeks (per trip) during the upcoming semester.
National University of Singapore logoNational University of Singapore
연구 책임자
Dr Falk Mueller-Riemenschneider, 책임연구자, Associate Professor, National University of Singapore
연구 대표 연락처
연락처: Sarah M Edney, PhD, +6591709231, [email protected]
연락처: Mingyue C Chen, +6591709231, [email protected]
시험기관의 위치 정보가 없습니다.