SleepSTEAMNCT04992611
Sleep Timing, Eating and Activity Measurement Study
A study testing Sleep Extension (Early) and Sleep Extension (Late) in people with Sleep and Circadian Rhythm Disorders, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Circadian Rhythm Disorders, Dietary Habits
- What is being tested?
- Sleep Extension (Early) and Sleep Extension (Late)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 26 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescents (any sex, gender, race, or ethnicity) aged 14-18 years, inclusive
Who cannot join
- Obesity, because findings are meant to inform obesity-prevention efforts
- Use of a psychiatric medication or other drug with known effects on sleep, weight, or dietary behaviors.
- Intellectual disability (aka mental retardation)
- Symptoms of insomnia, obstructive sleep apnea or periodic limb movement disorder, which could mask the effects of the sleep manipulation.
- Work or other obligations that require bedtime later than 9:30 pm or waking prior to 10 am (earliest bedtime and latest rise time possible during sleep extension) during the final week of the study, or other scheduling obligations that preclude participation.
- Daily consumption of >1 coffee or "energy drink" or >2 caffeinated sodas.
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- Currently diagnosed neurologic illness, history of seizures, or history of head injury resulting in loss of consciousness >1 min.
- Refusal to refrain from automobile driving during the sleep restriction period of the study.
- Symptoms of clinical depression, bipolar disorder, or psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Impact of Well-Timed vs. Mis-timed Sleep Extension on Adolescents' Dietary Intake
There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Before that can be translated into major public health interventions, however, the field needs to understand why similar changes in sleep had no effect, or even an adverse effect, on adolescent Night Owls. This experimental study will clarify why there have been such discrepant effects across Morning Larks and Night Owls, with the goal of more broadly harnessing the promise of improved sleep in the prevention of obesity and long-term morbidity.
Read the detailed description
Recent research shows that sleep could play a novel role in preventing obesity and long-term morbidity. Population studies find that too little sleep predicts the development of obesity and experimental studies show that short sleep increases dietary intake without increasing physical activity. Sleep may be a particularly potent intervention target for adolescents. During adolescence, inadequate sleep is very common, obesity rates are rising most, non-sleep-oriented obesity prevention programs have had least success, and young people can develop enduring dietary patterns that set the stage for life-long obesity and health risk. The investigators' lab has shown both the promise of longer sleep for adolescents and a critical knowledge gap. That lab found that extending adolescents' sleep via earlier bedtimes impressively reduced caloric intake for early chronotypes ("Morning Larks"; who prefer early bed- and rise times), but not late chronotypes ("Night Owls"; who prefer late bed- and rise times). The effect was not only statistically strong, but at roughly 400 calories difference per day, could add up to major shifts in body weight over time. Beyond calorie counts, there was a similar discrepancy in the glycemic load consumed by Larks and Owls after sleep extension, and glycemic load has been independently linked to long-term morbidity. The investigators assert that the discrepancy in how Larks and Owls responded to longer sleep is due to circadian misalignment: a mismatch between the timing of external sleep-wake demands and internal biological clock. They investigators propose that, for adolescent Owls, an early-to-bed intervention induces misaligned sleep timing that counters the benefits of longer sleep duration. In adults, severe circadian misalignment dramatically increases the risk for obesity, and even modest misalignment is linked to higher caloric intake. If a cause-effect relationship holds in adolescence, common sleep advice emphasizing earlier bedtimes might waste limited resources or even do harm for Owls. In contrast, an approach that considers chronotype might capitalize on the potent effect of improved sleep that has been shown for Larks. The current protocol reflects a novel experimental study in which 124 healthy 14-18-year-olds (62 Owls and 62 Larks) complete a 3-week trial involving periods of sleep restriction and sleep extension, in which the extension periods are randomly assigned to be aligned vs. misaligned relative to chronotype. Focusing independently on caloric intake and glycemic load, investigators will assess the dietary effect of sleep extension when it is well-timed versus poorly-timed relative to adolescents' internal clocks. The study will test a causal model in which sleep timing plays an important role in promoting or negating the benefits of sleep extension.
- Conditions
- Sleep, Circadian Rhythm Disorders, Dietary Habits
- Being tested
- Sleep Extension (Early), Sleep Extension (Late)
- Medical subject headings
- Chronobiology Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Extension (Early)Behavioural
Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping rise time the same as the sleep restriction period, but extending sleep by going to bed earlier. This produces a sleep extension that is aligned for Morning Larks and misaligned for Night Owls.
Sleep Extension (Late)Behavioural
Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping bedtime the same as the sleep restriction period, but extending sleep by rising later. This produces a sleep extension that is misaligned for Morning Larks and aligned for Night Owls.
| Study group | Role | What they receive |
|---|---|---|
| Circadian-Aligned Sleep Extension | Experimental | A sleep extension period that roughly conforms to a given participant's circadian phase (i.e., fits the schedule of a Morning Lark vs. Night Owl). Receives: Behavioral: Sleep Extension (Early); Behavioral: Sleep Extension (Late) |
| Circadian-Misaligned Sleep Extension | Experimental | A sleep extension period that does not conform to a given participant's circadian phase. In other words, this condition asks Morning Larks to extend their sleep by sleeping in later, or asks Night Owls to extend their sleep by going to bed earlier. Receives: Behavioral: Sleep Extension (Early); Behavioral: Sleep Extension (Late) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Caloric Intake Via 24-hr Recall Interviews Using the United States Department of Agriculture (USDA) Multiple Pass Method
Trained interviewers will engage adolescents in 30-min interviews regarding food consumption over the previous 24-hr periods. This method has been validated in youth against doubly labeled water and weighed diet diaries. Such interviews are relatively unobtrusive, measure the nature, timing, and volume eaten, and allow for professional cuing to promote recall accuracy. Recall interviews will be conducted blind to the alignment vs. misalignment randomization, as will conversion to nutritional data via Nutrition Data Systems for Research software.
Prior research suggests that dietary recall data are most reliable when averaged across several days within a given condition. Accordingly, participants will undergo three recalls across the multi-day sleep extension condition, with data from the three recalls averaged together.
Measured: Short Sleep Period (Week 2, between visits 1 and 2; pre-randomization), Healthy Sleep Period (Week 2, between visits 2 and 3; post-randomization)
Glycemic Load Consumed, as Measured Via 24-hr Recall Interviews (Based on Derived Scores; See Outcome Measure Description for Details on How Units of Measure Are Calculated)
The primary outcome for Aim 2 is the averaged daily glycemic load of foods consumed per day during the sleep extension condition, based on the same dietary recall interview procedures described above. Daily Glycemic Load is a "unitless" derived score that allows one to index how much the consumed food induces large swings in blood sugar, which an independent risk factor for chronic health condition. Calculation involves several steps:
- Each food is first characterized by a predetermined glycemic index, which is a 0-100 value that represents how fast and far it raises blood sugar.
- For each consumed food, glycemic load (GL) is the product of its glycemic index multiplied by the grams of available carbohydrate consumed by the participant, divided by 100.
- Total daily GL is the sum of glycemic load values across all foods consumed during a given day.
- Finally, for this primary outcome measure, we averaged the total daily GL across assessed days within a sleep condition.
Measured: Short Sleep Period (Week 2, between visits 1 and 2; pre-randomization), Healthy Sleep Period (Week 2, between visits 2 and 3; post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start16 Jul 2021
- Primary completion26 Jul 2025
- Study completion26 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Mechanistic clinical trial seeking to determine why there we have seen a difference in dietary response to sleep extension across chronotypes, with adolescent Morning Larks showing a dramatic protective effect not shared by Night Owls.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University
- Responsible party
- Sponsor
- Investigators
- Dean W Beebe, PhD, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992611
- Sponsor's protocol ID
- R01HL147915
- Acronym
- STEAM
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2021
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication of primary analyses (or within 2 years of study completion in the unlikely event of no such publication), we will have available the Final Dataset that has been de-identified in a HIPAA-compliant fashion and carefully reviewed to make sure that non-HIPAA-designated but potentially identifying information are not included (e.g., rather than have dates of birth and participation, we will include the more analytically-relevant variable of exact age). Descriptors for all variables shared will be included to prevent misuse or confusion. The Final Dataset will be provided at no charge to qualified individuals requesting it from the PI, and we will also make every effort to provide the dataset as a secondary file attached to the online version of the primary publication. Publications will make clear how to access that information.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Well-Timed vs. Mis-timed Sleep Extension on Adolescents' Dietary Intake
- ClinicalTrials.gov ID
- NCT04992611
- Acronym / sponsor ID
- STEAM / R01HL147915
- Conditions
- Sleep, Circadian Rhythm Disorders, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Rush University
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Jul 2025 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Before that can be translated into major public health interventions, however, the field needs to understand why similar changes in sleep had no effect, or even an adverse effect, on adolescent Night Owls. This experimental study will clarify why there have been such discrepant effects across Morning Larks and Night Owls, with the goal of more broadly harnessing the promise of improved sleep in the prevention of obesity and long-term morbidity.
Detailed description
Recent research shows that sleep could play a novel role in preventing obesity and long-term morbidity. Population studies find that too little sleep predicts the development of obesity and experimental studies show that short sleep increases dietary intake without increasing physical activity. Sleep may be a particularly potent intervention target for adolescents. During adolescence, inadequate sleep is very common, obesity rates are rising most, non-sleep-oriented obesity prevention programs have had least success, and young people can develop enduring dietary patterns that set the stage for life-long obesity and health risk. The investigators' lab has shown both the promise of longer sleep for adolescents and a critical knowledge gap. That lab found that extending adolescents' sleep via earlier bedtimes impressively reduced caloric intake for early chronotypes ("Morning Larks"; who prefer early bed- and rise times), but not late chronotypes ("Night Owls"; who prefer late bed- and rise times). The effect was not only statistically strong, but at roughly 400 calories difference per day, could add up to major shifts in body weight over time. Beyond calorie counts, there was a similar discrepancy in the glycemic load consumed by Larks and Owls after sleep extension, and glycemic load has been independently linked to long-term morbidity. The investigators assert that the discrepancy in how Larks and Owls responded to longer sleep is due to circadian misalignment: a mismatch between the timing of external sleep-wake demands and internal biological clock. They investigators propose that, for adolescent Owls, an early-to-bed intervention induces misaligned sleep timing that counters the benefits of longer sleep duration. In adults, severe circadian misalignment dramatically increases the risk for obesity, and even modest misalignment is linked to higher caloric intake. If a cause-effect relationship holds in adolescence, common sleep advice emphasizing earlier bedtimes might waste limited resources or even do harm for Owls. In contrast, an approach that considers chronotype might capitalize on the potent effect of improved sleep that has been shown for Larks. The current protocol reflects a novel experimental study in which 124 healthy 14-18-year-olds (62 Owls and 62 Larks) complete a 3-week trial involving periods of sleep restriction and sleep extension, in which the extension periods are randomly assigned to be aligned vs. misaligned relative to chronotype. Focusing independently on caloric intake and glycemic load, investigators will assess the dietary effect of sleep extension when it is well-timed versus poorly-timed relative to adolescents' internal clocks. The study will test a causal model in which sleep timing plays an important role in promoting or negating the benefits of sleep extension.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mechanistic clinical trial seeking to determine why there we have seen a difference in dietary response to sleep extension across chronotypes, with adolescent Morning Larks showing a dramatic protective effect not shared by Night Owls.
| Arm | Type | Receives |
|---|---|---|
| Circadian-Aligned Sleep Extension | Experimental | Behavioral: Sleep Extension (Early), Behavioral: Sleep Extension (Late)A sleep extension period that roughly conforms to a given participant's circadian phase (i.e., fits the schedule of a Morning Lark vs. Night Owl). |
| Circadian-Misaligned Sleep Extension | Experimental | Behavioral: Sleep Extension (Early), Behavioral: Sleep Extension (Late)A sleep extension period that does not conform to a given participant's circadian phase. In other words, this condition asks Morning Larks to extend their sleep by sleeping in later, or asks Night Owls to extend their sleep by going to bed earlier. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy adolescents (any sex, gender, race, or ethnicity) aged 14-18 years, inclusive
Key exclusion criteria (9 listed)
- Obesity, because findings are meant to inform obesity-prevention efforts
- Use of a psychiatric medication or other drug with known effects on sleep, weight, or dietary behaviors.
- Intellectual disability (aka mental retardation)
- Symptoms of insomnia, obstructive sleep apnea or periodic limb movement disorder, which could mask the effects of the sleep manipulation.
- Work or other obligations that require bedtime later than 9:30 pm or waking prior to 10 am (earliest bedtime and latest rise time possible during sleep extension) during the final week of the study, or other scheduling obligations that preclude 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 |
|---|---|---|
| Sleep Extension (Early)Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping rise time the same as the sleep restriction period, but extending sleep by going to bed earlier. This produces a sleep extension that is aligned for Morning Larks and misaligned for Night Owls. | Behavioural | Circadian-Aligned Sleep Extension, Circadian-Misaligned Sleep Extension |
| Sleep Extension (Late)Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping bedtime the same as the sleep restriction period, but extending sleep by rising later. This produces a sleep extension that is misaligned for Morning Larks and aligned for Night Owls. | Behavioural | Circadian-Aligned Sleep Extension, Circadian-Misaligned Sleep Extension |
Primary outcome
Overall Caloric Intake Via 24-hr Recall Interviews Using the United States Department of Agriculture (USDA) Multiple Pass Method
Time frame: Short Sleep Period (Week 2, between visits 1 and 2; pre-randomization), Healthy Sleep Period (Week 2, between visits 2 and 3; post-randomization)
Trained interviewers will engage adolescents in 30-min interviews regarding food consumption over the previous 24-hr periods. This method has been validated in youth against doubly labeled water and weighed diet diaries. Such interviews are relatively unobtrusive, measure the nature, timing, and volume eaten, and allow for professional cuing to promote recall accuracy. Recall interviews will be conducted blind to the alignment vs. misalignment randomization, as will conversion to nutritional data via Nutrition Data Systems for Research software. Prior research suggests that dietary recall data are most reliable when averaged across several days within a given condition. Accordingly, participants will undergo three recalls across the multi-day sleep extension condition, with data from the three recalls averaged together.
Glycemic Load Consumed, as Measured Via 24-hr Recall Interviews (Based on Derived Scores; See Outcome Measure Description for Details on How Units of Measure Are Calculated)
Time frame: Short Sleep Period (Week 2, between visits 1 and 2; pre-randomization), Healthy Sleep Period (Week 2, between visits 2 and 3; post-randomization)
The primary outcome for Aim 2 is the averaged daily glycemic load of foods consumed per day during the sleep extension condition, based on the same dietary recall interview procedures described above. Daily Glycemic Load is a "unitless" derived score that allows one to index how much the consumed food induces large swings in blood sugar, which an independent risk factor for chronic health condition. Calculation involves several steps: 1. Each food is first characterized by a predetermined glycemic index, which is a 0-100 value that represents how fast and far it raises blood sugar. 2. For each consumed food, glycemic load (GL) is the product of its glycemic index multiplied by the grams of available carbohydrate consumed by the participant, divided by 100. 3. Total daily GL is the sum of glycemic load values across all foods consumed during a given day. 4. Finally, for this primary outcome measure, we averaged the total daily GL across assessed days within a sleep condition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon publication of primary analyses (or within 2 years of study completion in the unlikely event of no such publication), we will have available the Final Dataset that has been de-identified in a HIPAA-compliant fashion and carefully reviewed to make sure that non-HIPAA-designated but potentially identifying information are not included (e.g., rather than have dates of birth and participation, we will include the more analytically-relevant variable of exact age). Descriptors for all variables shared will be included to prevent misuse or confusion. The Final Dataset will be provided at no charge to qualified individuals requesting it from the PI, and we will also make every effort to provide the dataset as a secondary file attached to the online version of the primary publication. Publications will make clear how to access that information.
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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.
Dean W Beebe, PhD principal investigator
Cincinnati Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension (Early) and Sleep Extension (Late) in people with Sleep and Circadian Rhythm Disorders, run by Children's Hospital Medical Center, Cincinnati 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 1 inclusion and 9 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 22 Sep 2026. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Caloric Intake Via 24-hr Recall Interviews Using the United States Department of Agriculture (USDA) Multiple Pass Method (time frame: Short Sleep Period (Week 2, between visits 1 and 2; pre-randomization), Healthy Sleep Period (Week 2, between visits 2 and 3; post-randomization)). 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?
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 22 Sep 2026.