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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep; Insulin Sensitivity; Overweight Adolescents
• Intervention / Treatment: Behavioral: Circadian/Sleep (C/S)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey L Simon, PhD; Phone Number: 720-777-5681; Email: stacey.simon@childrenscolorado.org
• Study Contact Backup: Name: Angel Arias, BS; Phone Number: 720-777-3491; Email: angel.arias@childrenscolorado.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. High school students between 14-19 years
2. Overweight/obesity (BMI >85% for age and sex)
3. Have habitually insufficient sleep, defined as ≤ 7 hours per night on school days
4. Habitually inactive (≤ 3 h of physical activity reported per week)
5. Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

1. Reported diagnosis of sleep disorder (e.g., insomnia, obstructive sleep apnea)
2. Medical comorbidities that impact sleep or insulin sensitivity (e.g., diabetes [based on history or screening HbA1c])
3. Regular use of medications affecting sleep or insulin sensitivity (e.g., stimulants, sleep aids, systemic steroids, insulin sensitizers, GLP-1 agonists)
4. IQ<70 or severe mental illness that may impact sleep or study participation (e.g., schizophrenia), eating disorder, or active suicidal ideation
5. Schedules that would preclude participants from adhering to the sleep schedules (e.g., night-shift employment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Typical Sleep; Habitual sleep schedule
Experimental: Circadian/Sleep (C/S) Condition; 1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking	Behavioral: Circadian/Sleep (C/S); 1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily energy expenditure (TDEE)	Assessed with doubly labeled water. Higher values indicate greater energy expenditure	Assessed for two weeks during each condition
Average daily caloric intake (kcal/day)	Calculated from photographic diet diaries. Higher kcal indicates greater caloric intake.	Measured for 3 days during each condition

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Stacey L Simon, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: 25-1531; 1R01DK142774-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No