Image

Circadian Intervention to Improve Cardiometabolic Health

Circadian Intervention to Improve Cardiometabolic Health

Recruiting
18-45 years
All
Phase N/A

Powered by AI

Overview

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).

Description

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.

Eligibility

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

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

NCT05943626

University of Utah

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.