RecruitingNot applicable

Circadian Intervention to Improve Cardiometabolic Health

Timing of Circadian Synchronizers: The TOCS Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether less light at night and fewer after-dinner snacks can improve heart and body health. It is for adults ages 18–45 who have overweight or obesity and usually sleep less than 6.5 hours a night. Participants are placed by chance into this program or a group that gets basic healthy lifestyle tips.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–45; the study seeks equal numbers of men and women.
  • Body mass index (BMI), a measure of weight based on height, of 25.0–34.9.
  • Report sleeping an average of less than 6.5 hours a night over the past 6 months.

Who can't join

  • A diagnosed sleep disorder or major mental illness.
  • A serious organ problem or disease, such as diabetes, heart disease, or kidney disease.
  • Use of prescription drugs or substances known to affect sleep or how the body handles sugar.
  • Shift work now or within the past year.
  • Weight changed by more than 10% in the past 6 months, or currently in a weight-loss or exercise program.
  • Going through menopause or past menopause, when monthly periods stop.
  • Pregnant, planning to become pregnant, or breastfeeding.
  • Currently smoking, or drinking more than 3 alcoholic drinks a day or more than 14 a week.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 25.0-34.9 kg/m2, 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism 4. Shift-work: current or history of within last year 5. Weight change: \>10% of body weight over prior six months 6. Experiencing menopause or post-menopausal 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 8. Currently pregnant or planning to become pregnant, or currently lactating. 9. Currently smoking 10. Alcohol intake \>3 drinks per day or \>14 drinks per week

Study sites (1)

UT