NCT05943626 · University of Utah
Circadian Intervention to Improve Cardiometabolic Health
(TOCS)
What this study is about
The overall goal is to examine the effectiveness of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomly assigned controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake.
View original scientific description
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 18-45 years old; equal numbers of men and women
- Body mass index (BMI): 25.0-34.9 kg/m2,
- Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months
Exclusion criteria
- Clinically diagnosed sleep disorder or major psychiatric illness
- Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
- Use of prescription drugs or substances known to influence sleep or glucose metabolism
- Shift-work: current or history of within last year
- Weight change: \>10% of body weight over prior six months
- Experiencing menopause or post-menopausal
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently pregnant or planning to become pregnant, or currently lactating.
- Currently smoking
- Alcohol intake \>3 drinks per day or \>14 drinks per week
Where
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 20, 2024 · Source of record for eligibility and locations