Actively Recruiting
Timing of Circadian Synchronizers: the TOCS Study on Cardiometabolic Health in Adults with Overweight and Obesity
Led by University of Utah · Updated on 2024-12-20
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how a circadian intervention might improve cardiometabolic health in adults who are overweight or obese and have a habit of sleeping less than 6.5 hours per night. This randomized controlled trial compares a circadian intervention group with a control group receiving general health advice. The study aims to understand effects on insulin sensitivity and circadian rhythms over approximately 8 weeks. Participants in the circadian intervention group receive counseling to reduce light exposure in the evening and night, increase morning light exposure, and finish eating at least 4 hours before bedtime. The control group receives basic health information about diet and physical activity but maintains their usual sleep and eating habits. Both groups are monitored for about 8 weeks following a baseline period, with equal contact time from the study team. Throughout the study, sleep is tracked using a wrist actiwatch and daily sleep logs. Participants complete overnight laboratory visits before and after the experimental period to assess insulin sensitivity and circadian timing through specific tests. Researchers will measure changes in insulin sensitivity, circadian clock timing, sleep duration and satisfaction, food intake timing, and daytime alertness. The total study participation includes a baseline monitoring week and the 8-week experimental segment.
CONDITIONS
Brief Title
Circadian Intervention to Improve Cardiometabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 45 years old with equal numbers of men and women
- Body mass index (BMI) between 25.0 and 34.9 kg/m2
- Habitual average total sleep time less than 6.5 hours per night for the prior 6 months
You will not qualify if you...
- Clinically diagnosed sleep disorder or major psychiatric illness
- Significant organ dysfunction or disease such as diagnosed diabetes, cardiovascular disease, or kidney disease
- Use of prescription drugs or substances that affect sleep or glucose metabolism
- Current or recent shift work within the last year
- Weight change greater than 10% in the past six months
- Experiencing menopause or post-menopausal
- Currently enrolled in weight loss or physical activity programs like the Diabetes Prevention Program
- Currently pregnant, planning pregnancy, or lactating
- Current smoking
- Alcohol intake exceeding 3 drinks per day or 14 drinks per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 clinical overnight sleep disorders screening visit (in-person)
Duration - Approximately 1 week
Participants complete about 1 week of ambulatory real-world monitoring including sleep duration tracking with an actiwatch wrist device and daily electronic sleep logs.
1 overnight laboratory visit at the end of baseline
Duration - Approximately 8 weeks
Participants are randomized to either the circadian intervention group receiving counseling on light exposure and food timing or to the control group maintaining habitual habits, both for an 8-week period.
Weekly contact with study team; 1 overnight laboratory visit at the end of intervention
Trial Site Locations
Total: 1 location
1
College of Health Research Complex--University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Christopher M Depner, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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