RECRUITING

Circadian Intervention to Improve Cardiometabolic Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Timing of Circadian Synchronizers: The TOCS Study

Quick Facts

Study Start:2023-06-13
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05943626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Study Contact

Christopher M Depner, PhD
CONTACT
801-581-2275
christopher.depner@utah.edu

Study Locations (Sites)

College of Health Research Complex--University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

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

Study Start Date2023-06-13
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-06-13
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

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