Circadian Intervention to Improve Cardiometabolic Health

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Timing of Circadian Synchronizers: The TOCS Study

Conditions
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Cardiometabolic Syndrome, Type 2 Diabetes, Sleep, Time Restricted Feeding, Lifestyle Factors, Overweight and Obesity, Insulin Sensitivity, Eating Habit, Sleep Hygiene

Intervention / Treatment
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* Behavioral: Circadian Intervention


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Provided with general health information on diet and physical activity. | |
| Experimental: Intervention Group<br>Circadian-based intervention focused on timing of light exposure and food intake. | Behavioral: Circadian Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity change from baseline | Oral Glucose Tolerance Test (OGTT), Matsuda Index | Change from baseline to end of the  8 week experimental segment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of central circadian clock change from baseline | Quantified as dim-light melatonin onset from salivary melatonin samples | Change from baseline to end of the  8 week experimental segment | 
| Plasma ceramides change from baseline | Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics | Change from baseline to end of the  8 week experimental segment | 
| Average (per week) nightly total sleep time change from baseline | Analyzed by wrist-actigraphy | Analyzed as change from baseline for each week of the  8 week experimental segment | 
| Average (per week) sleep satisfaction change from baseline | 5 point likert scale on daily sleep log (1 = very good; 5 = very poor) | Analyzed as change from baseline for each week of the  8 week experimental segment | 
| Average (per week) self-reported sleep duration change from baseline | Daily electronic sleep logs will be used to track sleep and waketimes during the ambulatory monitoring phases of the study | Analyzed as change from baseline for each week of the  8 week experimental segment | 
| Average (per week) timing of food intake change from baseline | 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 | Change from baseline to week 8 of the  8 week experimental segment | 
| Average (per week) daytime alertness change from baseline | 5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all) | Analyzed as change from baseline for each week of the  8 week experimental segment |