- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06597890
Move@NUS: a Digital Intervention Cohort Promoting Healthy Movement Behaviours
Move@NUS: Pilot Study of a Digital Intervention Cohort to Promote Healthy Sleep, Screen Viewing, and Physical Activity Habits for Improved Health and Wellbeing
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.
Study Overview
Status
Intervention / Treatment
- Behavioral: educational content (sleep hygiene)
- Behavioral: sleep hygiene strategies
- Behavioral: reminders
- Behavioral: review of behavioural goal
- Behavioral: goal setting
- Behavioral: educational content (sleep guidelines)
- Behavioral: comparison of current behaviour to ideal behaviour
- Behavioral: educational content (Vigorous Intermittent Lifestyle Physical Activity (VILPA))
- Behavioral: screentime breaks
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah M Edney, PhD
- Phone Number: +6591709231
- Email: sarah.edney@mymail.unisa.edu.au
Study Contact Backup
- Name: Mingyue C Chen
- Phone Number: +6591709231
- Email: mingyuecchen@u.nus.edu.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RCT 1 - group 1
Sleep Hygiene Ecological Momentary Intervention (EMI)
|
app-based sleep hygiene-related educational content
app-based self-selection of sleep hygiene strategies
daily reminders sent via push notifications
app-based review of behavioural goal
prompt participant to set a goal in relation to targeted behaviour
|
|
Experimental: RCT 1 - group 2
Personalised Sleep Guideline EMI
|
daily reminders sent via push notifications
app-based review of behavioural goal
prompt participant to set a goal in relation to targeted behaviour
app-based educational content on recommended sleep guidelines
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
|
|
No Intervention: RCT 1 - group 3
Control
|
|
|
Experimental: RCT 2 - group 1
Stair Climbing EMI
|
daily reminders sent via push notifications
app-based review of behavioural goal
prompt participant to set a goal in relation to targeted behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
|
|
Experimental: RCT 2 - group 2
Vigorous Intermittent Lifestyle Physical Activity (VILPA) EMI
|
daily reminders sent via push notifications
app-based review of behavioural goal
prompt participant to set a goal in relation to targeted behaviour
app-based educational content on VILPA
|
|
No Intervention: RCT 2 - group 3
Control
|
|
|
Experimental: RCT 3 - group 1
Screentime Breaktime EMI
|
app-based review of behavioural goal
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
repeated daily reminders to break up screentime
|
|
Experimental: RCT 3 - group 2
Screentime Goal EMI
|
daily reminders sent via push notifications
app-based review of behavioural goal
prompt participant to set a goal in relation to targeted behaviour
use of smartwatch/smartphone data to assess current behaviour and compare it to ideal behaviour
|
|
No Intervention: RCT 3 - group 3
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RCT 1. Sleep
Time Frame: week 1 (pre-intervention), week 3 (intervention midpoint), week 5 (post-intervention), and continuously throughout the 6-month study
|
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
Time Frame: week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
|
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
Time Frame: week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
|
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
Time Frame: week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
|
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
Time Frame: week 6 (pre-intervention), week 8 (intervention midpoint), week 10 (post-intervention), and continuously throughout the 6-month study
|
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
Time Frame: Continuously over 6-months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Falk Müller-Riemenschneider, PhD, National University of Singapore
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2023-800
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sedentary Behavior
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSedentary Behavior | Sedentary TimeUnited States
-
Stanford UniversityActive, not recruiting
-
University of California, San DiegoCompleted
-
Cairo UniversityRecruitingSedentary BehaviorsEgypt
-
Istanbul Aydın UniversityCompletedSedentary Lifestyle | Functional CapacityTurkey (Türkiye)
-
Gazi UniversityCompletedSedentary | Athlete | Core Muscle EnduranceTurkey (Türkiye)
-
China-Japan Friendship HospitalNot yet recruitingSedentary Lifestyle | Behavioral Intervention
-
Sezer TaştanCompletedSedentary Lifestyle | Cardiorespiratory FitnessTurkey (Türkiye)
-
Recep Tayyip Erdogan UniversityCompletedPhysical Inactivity | Sedentary BehaviorsTurkey (Türkiye)
-
Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
Clinical Trials on educational content (sleep hygiene)
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Diskapi Yildirim Beyazit Education and Research...CompletedDiabetes Mellitus, Type 2 | Sleep HygieneTurkey
-
National Taiwan University HospitalCompleted
-
Universidad Autónoma de YucatánNot yet recruitingMental Health | Sleep Quality | Students, MedicalMexico
-
Region StockholmActive, not recruiting
-
University of MichiganCompleted
-
João BarreiraNot yet recruiting
-
Oregon Health and Science UniversityCompletedPrimary Insomnia | Psychophysiological InsomniaUnited States
-
University of MilanCompleted
-
Bilecik Seyh Edebali UniversitesiNot yet recruiting