Circadian Intervention for Obesity (TOCS Trial)

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18-45 years old; equal numbers of men and women

Be between 18 and 65 years old

Must not have

Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)

Clinically diagnosed sleep disorder or major psychiatric illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 8 of the ~8 week experimental segment

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how two interventions help people with overweight/obesity and short sleep duration lose weight. One intervention focuses on reducing nighttime light and snack food, the other on health info.

Who is the study for?

This trial is for adults aged 18-45 with a BMI of 25.0-34.9 who sleep less than 6.5 hours nightly and are not currently in weight loss programs or experiencing menopause. It's not for those with significant organ diseases, diagnosed sleep disorders, psychiatric illnesses, heavy alcohol use, recent shift work history, or using drugs affecting sleep/glucose metabolism.

What is being tested?

The study tests a circadian intervention aimed at improving cardiometabolic health by reducing nighttime light exposure and after-dinner snacks versus a control group receiving basic health advice on physical activity and nutrition.

What are the potential side effects?

Potential side effects aren't specified but may include changes in sleeping patterns or appetite due to the lifestyle adjustments required by the circadian intervention compared to usual habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant health condition like diabetes, heart, or kidney disease.

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I have been diagnosed with a sleep disorder or major psychiatric illness.

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I am experiencing menopause or am post-menopausal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 8 of the ~8 week experimental segment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 8 of the ~8 week experimental segment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 8 of the ~8 week experimental segment for reporting.