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Behavioral Intervention

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

TOCS Trial 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.Check my eligibility

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.See study design

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.

TOCS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 45 years old.

TOCS Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin sensitivity change from baseline

Secondary outcome measures

Average (per week) daytime alertness change from baseline

Average (per week) nightly total sleep time change from baseline

Average (per week) self-reported sleep duration change from baseline

+4 more

TOCS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Circadian-based intervention focused on timing of light exposure and food intake.

Group II: Control GroupActive Control1 Intervention

Provided with general health information on diet and physical activity.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,881 Total Patients Enrolled

4 Trials studying Sleep

190 Patients Enrolled for Sleep

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility for this trial extend to individuals over fifty-five years of age?

"According to the conditions of acceptance for this research, participants must be between 18 and 45 years old."

Answered by AI

How many subjects have been enrolled in the research trial thus far?

"Affirmative. According to clinicaltrials.gov, this medical trial initiated on June 13th 2023 and is currently looking for participants, with the most recent update being October 9th 2023. There are 1 sites recruiting a total of 20 patients."

Answered by AI

Is there still capacity for new participants in this clinical trial?

"Affirmative. As per clinicaltrials.gov, this medical experiment is actively searching for test subjects as of October 9th 2023 - it was first posted on June 13th that same year. To date they are looking to recruit 20 individuals from a single site."

Answered by AI

Do I meet the requirements to join this clinical trial?

"This clinical trial includes 20 participants with cardiometabolic syndrome in the age range of 18-45. To be eligible, potential patients must have a BMI between 25 and 34.9 kg/m2, and report having slept less than 6.5 hours per night over the last six months; furthermore, it is essential that there are equal amounts of both male and female candidates involved for accurate results to be obtained."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Circadian Intervention to Improve Cardiometabolic Health

Christopher Depner 2023. "Circadian Intervention to Improve Cardiometabolic Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05943626.

All > Metabolic Syndrome