Circadian Intervention to Improve Cardiometabolic Health
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).
Conditions:
🦠 Cardiometabolic Syndrome 🦠 Type 2 Diabetes 🦠 Sleep 🦠 Time Restricted Feeding 🦠 Lifestyle Factors 🦠 Overweight and Obesity 🦠 Insulin Sensitivity 🦠 Eating Habit 🦠 Sleep Hygiene
🗓️ Study Start (Actual) 13 June 2023
🗓️ Primary Completion (Estimated) March 2026
✅ Study Completion (Estimated) March 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age: 18-45 years old; equal numbers of men and women
    • 2. Body mass index (BMI): 25.0-34.9 kg/m2,
    • 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months

    Exclusion Criteria:

    • 1. Clinically diagnosed sleep disorder or major psychiatric illness
    • 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
    • 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism
    • 4. Shift-work: current or history of within last year
    • 5. Weight change: \>10% of body weight over prior six months
    • 6. Experiencing menopause or post-menopausal
    • 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
    • 8. Currently pregnant or planning to become pregnant, or currently lactating.
    • 9. Currently smoking
    • 10. Alcohol intake \>3 drinks per day or \>14 drinks per week
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 June 2023
  • First Submitted that Met QC Criteria 5 July 2023
  • First Posted 13 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 October 2023
  • Last Update Posted 11 October 2023
  • Last Verified October 2023