SleepNCT01508793
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
A study testing Optimize Sleep in people with Sleep and Obesity, run by The Miriam Hospital at 2 sites in United States.
Trial summary
The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize… Read more about this study
- Who is it for?
- Ages 8 to 11 years
- What is being tested?
- Optimize Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Nov 2016
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-11 years old
- BMI for age and gender > 10th percentile (but no greater than 100% overweight)
- Sleep 9.5 hours or less nightly
- Attend elementary school
- Like at least 1 food used in the reinforcement paradigm
- Able to understand and complete the reinforcement paradigm
Who cannot join
- Existence of a diagnosable parasomnia, sleep disordered breathing
- Medical or psychiatric condition that could influence sleep or weight
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140
The Miriam Hospital
Providence, Rhode Island, 02903
About this study
The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.
- Being tested
- Optimize Sleep
- Keywords
- Sleep, Obesity, Children, Eating behaviors, Activity
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimize SleepBehavioural
Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Optimize Sleep | Experimental | Not described Receives: Behavioral: Optimize Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Duration
Measured with actigraphy
Measured: Baseline, 2-weeks, and 2-months
Change in Dietary Intake
Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)
Measured: Baseline, 2-weeks, and 2-months
Secondary outcomes (3)
Change in the Reinforcing Value of Food
Measured using a computer paradigm, the Behavioral Choice Task
Measured: Baseline, 2-weeks, and 2-months
Change in activity
Physical and sedentary activities assessed using accelerometers and self-report
Measured: Baseline, 2-week, and 2-month
Change in zBMI
Based on measured height and weight
Measured: Baseline, 2-week, and 2-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionNov 2016
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 SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
- Investigators
- Chantelle N Hart, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508793
- Sponsor's protocol ID
- R01HL092910
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2012
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hart CN, Coffman DL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Hawley NL, Wing RR. Earlier Bedtimes Mediate the Effect of a Brief Behavioral Sleep Intervention on Children's Weight Status. J Pediatr. 2025 Jan;276:114265. doi: 10.1016/j.jpeds.2024.114265. Epub 2024 Aug 28.
PubMed 39214349
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
- ClinicalTrials.gov ID
- NCT01508793
- Acronym / sponsor ID
- R01HL092910
- Keywords
- Sleep, Obesity, Children, Eating behaviors, Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Jan 2012 (estimated)
- 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 proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Optimize Sleep | Experimental | Behavioral: Optimize Sleep |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 8-11 years old
- BMI for age and gender > 10th percentile (but no greater than 100% overweight)
- Sleep 9.5 hours or less nightly
- Attend elementary school
- Like at least 1 food used in the reinforcement paradigm
Key exclusion criteria (4 listed)
- Existence of a diagnosable parasomnia, sleep disordered breathing
- Medical or psychiatric condition that could influence sleep or weight
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
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 |
|---|---|---|
| Optimize SleepChildren are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention | Behavioural | Optimize Sleep |
Primary outcome
Change in Sleep Duration
Time frame: Baseline, 2-weeks, and 2-months
Measured with actigraphy
Change in Dietary Intake
Time frame: Baseline, 2-weeks, and 2-months
Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)
3 secondary outcomes
Change in the Reinforcing Value of Food
Time frame: Baseline, 2-weeks, and 2-months
Change in activity
Time frame: Baseline, 2-week, and 2-month
Change in zBMI
Time frame: Baseline, 2-week, and 2-month
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 6 Jan 2021.
- Derived from this study: PubMed 39214349Hart CN, Coffman DL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Hawley NL, Wing RR. Earlier Bedtimes Mediate the Effect of a Brief Behavioral Sleep Intervention on Children's Weight Status. J Pediatr. 2025 Jan;276:114265. doi: 10.1016/j.jpeds.2024.114265. Epub 2024 Aug 28.
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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.
Chantelle N Hart, Ph.D. principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimize Sleep in people with Sleep and Obesity, run by The Miriam Hospital at 2 sites 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 6 inclusion and 4 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Sleep Duration (time frame: Baseline, 2-weeks, and 2-months). The study lists 2 primary outcomes in all. 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 NCT01508793, 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 6 Jan 2021.