Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Circadian/Sleep (C/S).
- Who it may be relevant to
- Registry conditions: Overweight Adolescents, Sleep, Insulin Sensitivity. Basic parameters: 14 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mitigating Cardiometabolic Risk by Improving Sleep Health and Circadian Timing in Adolescents With Overweight/Obesity
Overview
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.
Interventions
- Behavioral Circadian/Sleep (C/S)
1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking
Primary outcome measures
- Insulin sensitivity [Time frame: Assessed at 2 weeks following each condition]
Secondary outcome measures (2)
- Total daily energy expenditure (TDEE) [Time frame: Assessed for two weeks during each condition]
- Average daily caloric intake (kcal/day) [Time frame: Measured for 3 days during each condition]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07618117 · 25-1531 · 1R01DK142774-01