College of Health Research Complex--University of Utah
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
NCT Number: NCT05943626
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).
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for ~8 weeks. Both groups will have equal contact time with the study team.
Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Time frame: Change from baseline to end of the ~8 week experimental segment
Oral Glucose Tolerance Test (OGTT), Matsuda Index
Time frame: Change from baseline to end of the ~8 week experimental segment
Quantified as dim-light melatonin onset from salivary melatonin samples
Time frame: Change from baseline to end of the ~8 week experimental segment
Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Analyzed by wrist-actigraphy
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Daily electronic sleep logs will be used to track sleep and waketimes during the ambulatory monitoring phases of the study
Time frame: Change from baseline to week 8 of the ~8 week experimental segment
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of 2 weekdays and 1 weekend day for baseline and final week of intervention
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Contact information is provided by the study sponsor or research team.
University of Utah
Other
Timing of Circadian Synchronizers: the TOCS Study
Acronym: TOCS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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