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Sleep Timing, Eating and Activity Measurement Study (STEAM)

Primary Purpose

Sleep, Circadian Rhythm Disorders, Dietary Habits

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Extension (Early)
Sleep Extension (Late)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adolescents (any sex, gender, race, or ethnicity) aged 14-18 years, inclusive

Exclusion Criteria:

  1. Obesity, because findings are meant to inform obesity-prevention efforts
  2. Use of a psychiatric medication or other drug with known effects on sleep, weight, or dietary behaviors.
  3. Intellectual disability (aka mental retardation)
  4. Symptoms of insomnia, obstructive sleep apnea or periodic limb movement disorder, which could mask the effects of the sleep manipulation.
  5. 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.
  6. Daily consumption of >1 coffee or "energy drink" or >2 caffeinated sodas.
  7. Currently diagnosed neurologic illness, history of seizures, or history of head injury resulting in loss of consciousness >1 min.
  8. Refusal to refrain from automobile driving during the sleep restriction period of the study.
  9. Symptoms of clinical depression, bipolar disorder, or psychosis.

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Circadian-Aligned Sleep Extension

Circadian-Misaligned Sleep Extension

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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. The primary outcome measure for Aim 1 will be average caloric intake across recalls during sleep extension.
Glycemic load consumed, as measured via 24-hr recall interviews
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. Glycemic load moves beyond calorie counts to instead index how much the consumed food induces large swings in blood sugar, which is an independent risk factor for chronic health condition.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2021
Last Updated
April 13, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Rush University
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1. Study Identification

Unique Protocol Identification Number
NCT04992611
Brief Title
Sleep Timing, Eating and Activity Measurement Study
Acronym
STEAM
Official Title
Impact of Well-Timed vs. Mis-timed Sleep Extension on Adolescents' Dietary Intake
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Rush University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Circadian Rhythm Disorders, Dietary Habits

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circadian-Aligned Sleep Extension
Arm Type
Experimental
Arm Description
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).
Arm Title
Circadian-Misaligned Sleep Extension
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension (Early)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension (Late)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Caloric Intake via 24-hr recall interviews using the United States Department of Agriculture (USDA) Multiple Pass Method
Description
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. The primary outcome measure for Aim 1 will be average caloric intake across recalls during sleep extension.
Time Frame
Through Study completion, up to 3 weeks for any given participant.
Title
Glycemic load consumed, as measured via 24-hr recall interviews
Description
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. Glycemic load moves beyond calorie counts to instead index how much the consumed food induces large swings in blood sugar, which is an independent risk factor for chronic health condition.
Time Frame
Through Study completion, up to 3 weeks for any given participant.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adolescents (any sex, gender, race, or ethnicity) aged 14-18 years, inclusive Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dean W Beebe, PhD
Phone
513-636-3489
Email
dean.beebe@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Wall, BA
Phone
513-636-8104
Email
Caroline.Wall@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean W Beebe, PhD
Organizational Affiliation
Cincinnati Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean W Beebe, PhD
Phone
513-636-3489
Email
dean.beebe@cchmc.org
First Name & Middle Initial & Last Name & Degree
Caroline Wall, BA
Phone
513-636-8104
Email
Caroline.Wall@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
From the time of publication of primary analyses through approximately 10 subsequent years.
IPD Sharing Access Criteria
If not openly available as a secondary file linked to the primary analysis publication, data will be made available upon request to the PI by a qualified professional.

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Sleep Timing, Eating and Activity Measurement Study

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