Sleep Timing, Eating and Activity Measurement Study

NCT04992611 | Completed

• 1 other identifier: R01HL147915
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Habits; Sleep; Circadian Rhythm Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  Through Study completion, up to 3 weeks for any given participant.

• 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.

  Through Study completion, up to 3 weeks for any given participant.

Study Arms (2)

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).

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.

Behavioral: Sleep Extension (Early); Behavioral: Sleep Extension (Late)

Interventions

Sleep Extension (Early) BEHAVIORAL

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.

Circadian-Aligned Sleep Extension; Circadian-Misaligned Sleep Extension

Sleep Extension (Late) BEHAVIORAL

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.

Circadian-Aligned Sleep Extension; Circadian-Misaligned Sleep Extension

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Rush University: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Nervous System Diseases; Behavior, Animal; Behavior

Study Officials

• Dean W Beebe, PhD

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: July 16, 2021
• Primary Completion: July 26, 2025
• Study Completion: July 26, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the time of publication of primary analyses through approximately 10 subsequent years.
• 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.

Locations

US (1)