RECRUITING

Circadian Misalignment and Energy Balance

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

Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.

Official Title

Impact of Circadian Misalignment on Energy Balance Regulation

Quick Facts

Study Start:2019-01-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03663530

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:20 Years to 49 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * All racial and ethnic groups
  2. * Body mass index 20-34.9 kg/m2
  3. * Average sleep duration ≥7 hour/night, assessed during 2-week screening period
  4. * Eat within 1 hour of awakening at least 5 days/week
  5. * Midpoint of sleep at 4 AM or earlier
  1. * \<10 nights of sleep \<7 hour during the 2-week screening period
  2. * Daytime napping
  3. * Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score \>10
  4. * Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
  5. * Any psychological or psychiatric disorder deemed to interfere with study outcomes
  6. * Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers \<3 years)
  7. * Night and rotating shift work
  8. * Travel across time zones within 4 wk of the study
  9. * History of drug or alcohol abuse or excessive alcohol consumption (\>3 drinks/day for men or 2 for women)
  10. * Recent weight change (\>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure
  11. * Pregnancy or \<1 year post-partum
  12. * Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
  13. * Depression (score \>13 on Beck Depression Inventory II) or taking anti-depressive medications
  14. * Restless leg syndrome and circadian rhythm disorders
  15. * Dementia or cognitive impairments
  16. * Taking psychoactive or hypnotic medications
  17. * Taking chronic analgesic or anti-inflammatory medications
  18. * Having had gastrointestinal surgery, including gastric bypass surgery
  19. * Restrained eating or abnormal scores on the Three Factor Eating Questionnaire
  20. * Contraindications for magnetic resonance imaging scanning
  21. * Hematocrit \<30%
  22. * Taking beta blockers, as this can interfere with melatonin secretion

Contacts and Locations

Study Contact

Lena Navarro
CONTACT
347-963-8845
lrn2116@cumc.columbia.edu
Claudia Dreyer
CONTACT
347-881-6008
cd3003@cumc.columbia.edu

Principal Investigator

Marie-Pierre St-Onge, PhD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Marie-Pierre St-Onge, PhD, PRINCIPAL_INVESTIGATOR, Columbia University

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 Date2019-01-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-01-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Food intake
  • Energy expenditure
  • Body composition
  • Meal timing

Additional Relevant MeSH Terms

  • Obesity