Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
REST
Mitigating Cardiometabolic Risk by Improving Sleep Health and Circadian Timing in Adolescents With Overweight/Obesity
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Many teenagers get too little and late timed sleep. High body weight and diabetes are increasing in teenagers as well. This study plans to learn more about whether improving sleep habits can help improve how the body regulates blood sugar and energy use in teenagers who have higher body weight. To answer this question, the investigators plan to enroll teenagers who get \<7 hours of sleep on school nights and measure changes in blood sugars and energy use after two weeks of typical sleep (sleeping on their normal school schedule) and two weeks of a sleep intervention that includes spending longer time in bed at night, melatonin, and morning light.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedStudy Start
First participant enrolled
August 25, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2030
Study Completion
Last participant's last visit for all outcomes
August 30, 2030
June 1, 2026
May 1, 2026
3.8 years
May 13, 2026
May 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
Matsuda Index will be calculated from a mixed meal tolerance test (MMTT); higher values indicate better insulin sensitivity.
Assessed at 2 weeks following each condition
Secondary Outcomes (2)
Total daily energy expenditure (TDEE)
Assessed for two weeks during each condition
Average daily caloric intake (kcal/day)
Measured for 3 days during each condition
Study Arms (2)
Typical Sleep
NO INTERVENTIONHabitual sleep schedule
Circadian/Sleep (C/S) Condition
EXPERIMENTAL1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking
Interventions
1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking
Eligibility Criteria
You may qualify if:
- High school students between 14-19 years
- Overweight/obesity (BMI \>85% for age and sex)
- Have habitually insufficient sleep, defined as ≤ 7 hours per night on school days
- Habitually inactive (≤ 3 h of physical activity reported per week)
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
You may not qualify if:
- Reported diagnosis of sleep disorder (e.g., insomnia, obstructive sleep apnea)
- Medical comorbidities that impact sleep or insulin sensitivity (e.g., diabetes \[based on history or screening HbA1c\])
- Regular use of medications affecting sleep or insulin sensitivity (e.g., stimulants, sleep aids, systemic steroids, insulin sensitizers, GLP-1 agonists)
- IQ\<70 or severe mental illness that may impact sleep or study participation (e.g., schizophrenia), eating disorder, or active suicidal ideation
- Schedules that would preclude participants from adhering to the sleep schedules (e.g., night-shift employment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey L Simon
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
June 1, 2026
Study Start (Estimated)
August 25, 2026
Primary Completion (Estimated)
June 15, 2030
Study Completion (Estimated)
August 30, 2030
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to study IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu.
Data obtained through this study may be provided to qualified researchers with academic interests. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.