ObesityNCT04303637
The Impact of Phone Use on Everyday Outcomes
An observational study of Obesity and Sleep, run by Yale-NUS College at 1 site in Singapore.
Trial summary
Participants will download a phone-tracking app for a week to track phone usage, providing objective data on usage patterns. Quantitative tasks and questionnaires will also be carried out before and after the tracking period. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sleep, Depression
- What is being tested?
- Phone use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Mar 2019to 10 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents aged 13-18 years old recruited from Singapore schools.
Who may be able to join
- Owns a smartphone
Who cannot join
- Parents not willing to give consent
- History of medical or psychiatric disorder
- History of motion sickness, dizziness or epilepsy
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Yale-NUS College
Singapore, 138527
Jean Liu, PhD, jeanliu@yale-nus.edu.sg
About this study
Participants will download a phone-tracking app for a week to track phone usage, providing objective data on usage patterns. Quantitative tasks and questionnaires will also be carried out before and after the tracking period.
Read the detailed description
A notable shortcoming of existing mobile phone research is that 'phone use' has almost exclusively been measured through subjective reports - by simply asking respondents how much time they spend on their mobile phones each day. This operational definition, however, is a major shortcoming as phone use is difficult to track - and is thus likely to be highly inaccurate.
To address this gap, the investigators describe in this proposal a first step to characterize phone usage in an objective manner - by asking adolescents to download a phone-tracking app for a week. This circumvents measurement errors inherent to self-reports, and allows us to probe: (1) how accurate adolescents' estimates are of their own phone usage, and (2) whether objective phone usage predicts any cognitive, socio-emotional, or physical outcomes. The completion of this study will represent an important step forward in the development of empirically-driven guidelines on phone use amongst adolescents.
- Conditions
- Obesity, Sleep, Depression, Anxiety
- Being tested
- Phone use
- Keywords
- Smartphone, Screen time
- Medical subject headings
- Obesity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone useBehavioural
Objective and subjective reports of smartphone use (e.g., number of hours, number of pick-ups, how phones are used)
| Study group | Role | What they receive |
|---|---|---|
| High school student | 13-18 year old students enrolled in schools within Singapore. Receives: Behavioral: Phone use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS 21)
A 21-item, 4-point scale measuring participant emotional states. This is the short form of the longer 42-item DASS.
Measured: 11 minutes (single measurement)
Body mass index
Participants' body mass index
Measured: 1 minute (single measurement)
Sleep duration
Assessment of participants' sleep time \& wake time
Measured: 2 minute (single measurement)
Secondary outcomes (4)
Digit Span Task
A digit span task carried out using a computer program
Measured: 10 minutes (single measurement)
Psychomotor Vigilance Task
PVT carried out using a computer program
Measured: 10 minutes (single measurement)
Pediatric Daytime Sleepiness Scale (PDSS)
A 8-item, 5-point self-report scale to measure sleepiness during the day.
Measured: 5 minutes (single measurement)
Strengths and Difficulties Questionnaire (SDQ)
A questionnaire looking at a student's emotional and behavioural aspects in relation to coping with school.
Measured: 10 minutes (single measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start25 Mar 2019
- Primary completion31 May 2021 (estimated)
- Study completion10 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Liu, Yale-NUS College
- Investigators
- Jean Liu, PhD, Principal investigator, Yale-NUS College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303637
- Sponsor's protocol ID
- S-18-213
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Stipulations by the institutional review board do not allow individualized data to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Phone Use on Everyday Outcomes
- ClinicalTrials.gov ID
- NCT04303637
- Acronym / sponsor ID
- S-18-213
- Conditions
- Obesity, Sleep, Depression, Anxiety
- Keywords
- Smartphone, Screen time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will download a phone-tracking app for a week to track phone usage, providing objective data on usage patterns. Quantitative tasks and questionnaires will also be carried out before and after the tracking period.
Detailed description
A notable shortcoming of existing mobile phone research is that 'phone use' has almost exclusively been measured through subjective reports - by simply asking respondents how much time they spend on their mobile phones each day. This operational definition, however, is a major shortcoming as phone use is difficult to track - and is thus likely to be highly inaccurate.
To address this gap, the investigators describe in this proposal a first step to characterize phone usage in an objective manner - by asking adolescents to download a phone-tracking app for a week. This circumvents measurement errors inherent to self-reports, and allows us to probe: (1) how accurate adolescents' estimates are of their own phone usage, and (2) whether objective phone usage predicts any cognitive, socio-emotional, or physical outcomes. The completion of this study will represent an important step forward in the development of empirically-driven guidelines on phone use amongst adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High school student | – | Behavioral: Phone use13-18 year old students enrolled in schools within Singapore. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents aged 13-18 years old recruited from Singapore schools.
Key inclusion criteria (1 listed)
- Owns a smartphone
Key exclusion criteria (3 listed)
- Parents not willing to give consent
- History of medical or psychiatric disorder
- History of motion sickness, dizziness or epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone useObjective and subjective reports of smartphone use (e.g., number of hours, number of pick-ups, how phones are used) | Behavioural | High school student |
Primary outcome
Depression Anxiety Stress Scale (DASS 21)
Time frame: 11 minutes (single measurement)
A 21-item, 4-point scale measuring participant emotional states. This is the short form of the longer 42-item DASS.
Body mass index
Time frame: 1 minute (single measurement)
Participants' body mass index
Sleep duration
Time frame: 2 minute (single measurement)
Assessment of participants' sleep time \& wake time
4 secondary outcomes
Digit Span Task
Time frame: 10 minutes (single measurement)
Psychomotor Vigilance Task
Time frame: 10 minutes (single measurement)
Pediatric Daytime Sleepiness Scale (PDSS)
Time frame: 5 minutes (single measurement)
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 10 minutes (single measurement)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No. Stipulations by the institutional review board do not allow individualized data to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Liu, PhD principal investigator
Yale-NUS College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sleep, run by Yale-NUS College at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Liu, PhD (66013694, jeanliu@yale-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS 21) (time frame: 11 minutes (single measurement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.