Childhood Sleep PromotionNCT03263338
Mobile Sleep and Growth Study
A study testing Mobile Sleep and Growth Study in people with Childhood Sleep Promotion, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Sleep Promotion
- What is being tested?
- Mobile Sleep and Growth Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 6 Jun 2018
- Phase
- Interventional
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females age 10 to 12 years.
- Speak, read and write in English.
- Parental/guardian permission (informed consent) and child assent.
- Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm \& get out of bed at 6am).
Who cannot join
- Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- Syndromic obesity.
- Diagnosed with a psychiatric disorder [e.g. Attention-deficit/hyperactivity disorder (ADHD), depression, anxiety].
- Diagnosed with an eating disorder.
- Musculoskeletal or neurological disorder that limits physical movement and activity.
- Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Mobile Health Sleep and Growth Study
The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor.
- Conditions
- Childhood Sleep Promotion
- Being tested
- Mobile Sleep and Growth Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Sleep and Growth StudyBehavioural
The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. Receives: Behavioral: Mobile Sleep and Growth Study |
| Group B | Experimental | Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group B. Receives: Behavioral: Mobile Sleep and Growth Study |
| Group C | Experimental | Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group C. Receives: Behavioral: Mobile Sleep and Growth Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in bed
Time in bed is estimated using a Fitbit activity tracker
Measured: 50-days
Secondary outcomes (1)
Total sleep time
Total sleep time is estimated using a Fitbit activity tracker
Measured: 50-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start10 Aug 2017
- Primary completion19 Oct 2017
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Sleep PromotionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Mitchell, Principal investigator, Research Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263338
- Sponsor's protocol ID
- 17-014078
- Status last verified
- Sep 2018
- First submitted
- 24 Aug 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.
PubMed 33981997
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Sleep and Growth Study
- ClinicalTrials.gov ID
- NCT03263338
- Acronym / sponsor ID
- 17-014078
- Conditions
- Childhood Sleep Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 28 Aug 2017 (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.
The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Mobile Sleep and Growth StudyParticipants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. |
| Group B | Experimental | Behavioral: Mobile Sleep and Growth StudyParticipants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group B. |
| Group C | Experimental | Behavioral: Mobile Sleep and Growth StudyParticipants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group C. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females age 10 to 12 years.
- Speak, read and write in English.
- Parental/guardian permission (informed consent) and child assent.
- Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm \& get out of bed at 6am).
Key exclusion criteria (6 listed)
- Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- Syndromic obesity.
- Diagnosed with a psychiatric disorder [e.g. Attention-deficit/hyperactivity disorder (ADHD), depression, anxiety].
- Diagnosed with an eating disorder.
- Musculoskeletal or neurological disorder that limits physical movement and activity.
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 |
|---|---|---|
| Mobile Sleep and Growth StudyThe intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets. | Behavioural | Group A, Group B, Group C |
Primary outcome
Time in bed
Time frame: 50-days
Time in bed is estimated using a Fitbit activity tracker
1 secondary outcome
Total sleep time
Time frame: 50-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 33981997Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Childhood Sleep Promotion
Not yet recruiting
Newenkantun: a Play-based Program to Promote Socioemotional Learning in Early Childhood Education in Chile.
Socioemotional Development, Physical Activity
Recruiting
The Bloom Study - a Safe and Healthy Start in Life
Overweight, Childhood, Obesity in Children
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.
Jonathan Mitchell principal investigator
Research Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Sleep and Growth Study in people with Childhood Sleep Promotion, run by Children's Hospital of Philadelphia at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in bed (time frame: 50-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263338, which also lists 1 linked publication.
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 19 Sep 2018.