Circadian Intervention to Improve Cardiometabolic Health (NCT05943626) | Clinical Trial Compass
RecruitingNot Applicable
Circadian Intervention to Improve Cardiometabolic Health
United States20 participantsStarted 2023-06-13
Plain-language summary
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
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing time-restricted feeding and sleep hygiene as a way to improve insulin sensitivity — given my current blood sugar control and diabetes management, does my doctor think focusing on when I eat and sleep could realistically move the needle for me?
2Since this trial is listed as Phase NA, which often means it's a behavioral or lifestyle study rather than a drug trial, can my doctor explain what that means for how well-established the safety of this approach is compared to my current treatment plan?
3The study involves changing both eating windows and sleep habits at the same time — how disruptive does my doctor think that kind of dual lifestyle change would be for someone in my situation, and are there any health reasons it might not be a good fit for me?
4If I were to join this trial and it didn't work well for my insulin sensitivity, would my doctor be able to easily transition me back to or onto a standard medication-based treatment without having lost ground on my cardiometabolic health?
5Are there already proven lifestyle or medication options my doctor would recommend I try first before enrolling in a research study that is still measuring whether this circadian-based approach actually improves insulin sensitivity?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insulin sensitivity change from baseline
Timeframe: Change from baseline to end of the ~8 week experimental segment