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NCT03680989 · ClinicalTrials.gov registry record · NA
A Pilot Test of Mood and Circadian Rhythm Mechanisms Driving Binge Eating
A NA study of Binge Eating and Circadian Dysregulation, sponsored by University of Wyoming.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03680989: Completed NA study of Binge Eating and Circadian Dysregulation, sponsored by University of Wyoming.
NCT03680989 is a NA study of Binge Eating and Circadian Dysregulation that has completed, run by University of Wyoming. The registered enrollment target is 35 participants, below the 91-participant average among 18 other Binge Eating trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03680989, a NA study of Binge Eating and Circadian Dysregulation, has completed, sponsored by University of Wyoming.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Mood and circadian rhythm disruptions are associated with binge eating (BE). BE is a discrete, episodic behavior characterized by 1) eating an objectively large amount of food and 2) experiencing a subjective sense of loss of control. BE episodes are often preceded by negative mood states, and a subtype of individuals with BE has high levels of negative moods. This group has more comorbid psychopathology and a poorer response to treatment. Thus, understanding the role of negative mood is a critical area for research on BE. Individuals with BE demonstrate disruptions in several circadian rhythms, including diurnal meal timing, hormone patterns (e.g., daily cortisol rhythms), and mood variations. The most potent synchronizer of circadian rhythms is light. Thus, exposure to light may explain other phenomena that fluctuate similarly, such as mood and the occurrence of BE. Mood is subject to the influence of light, and BE is also influenced by exposure to bright light. It is unknown whether regulating circadian rhythms via regular exposure to light improves BE through its effects on mood or via changes in other biological or behavioral rhythms. This knowledge can inform the development of treatments targeting biobehavioral mechanisms that maintain BE and indicate for whom this may be most effective. This project aims to test the roles of negative mood and circadian rhythms in the relationship between light exposure and BE and identify subtypes of individuals in whom this effect is strong. The investigators hypothesize that individuals exposed to less natural bright light will experience more frequent BE, more negative mood, and a blunted morning cortisol response. The investigators further hypothesize that manipulating exposure to artificial bright light will reduce the frequency of BE and negative mood and increase the morning cortisol response. Finally, the investigators hypothesize that the effects of this artificial bright light exposure on BE frequency will be media
Primary Outcome
The cortisol awakening response will estimated from saliva samples collected at home via passive drool (0.5 ml) at three times: immediately upon waking, 15 minutes after waking, and 30 minutes after waking. The curve of this response can be estimated from these three measurements. The response will be averaged over two consecutive days of collection and then compared between the two intervention phases to quantify the change in the awakening response accounted for by the interventions while cont
Conditions Studied
Interventions
- DEVICE Bright Light Exposure
- DEVICE Natural Light Exposure
Study Locations (1)
Wyoming
- University of Wyoming - Laramie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2020-03-15 |
| Phase | NA |
What the finished NCT03680989 record still lists
NCT03680989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 91-participant average among 18 other Binge Eating trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Binge Eating appearing as the primary indexed condition, and to 2 interventions - of which Bright Light Exposure is the first listed.
NCT03680989 reports a single indexed study location in Wyoming.
Frequently Asked Questions
What is clinical trial NCT03680989 about?
NCT03680989 is a clinical study titled "A Pilot Test of Mood and Circadian Rhythm Mechanisms Driving Binge Eating". Mood and circadian rhythm disruptions are associated with binge eating (BE). BE is a discrete, episodic behavior characterized by 1) eating an objectively large amount of food and 2) experiencing a subjective sense of loss of control. BE episodes are often preceded by negative mood states, and a sub...
What is the current status of trial NCT03680989?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2019-02-15. Estimated completion is 2020-03-15.
What conditions does trial NCT03680989 study?
This clinical trial studies the following conditions: Binge Eating, Circadian Dysregulation, Eating Disorder.
What interventions are being tested in trial NCT03680989?
The interventions under investigation include: Bright Light Exposure (DEVICE), Natural Light Exposure (DEVICE).
Who is sponsoring clinical trial NCT03680989?
This trial is sponsored by University of Wyoming, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03680989 being conducted?
This trial has 1 study location across Wyoming. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03680989's enrollment target sits among peer trials
35 16th of 18 higher than 3 of 18 other Binge Eating trials
participants (enrollment target), bucketed by value
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