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Behavioural Intervention

Fasting and Eating Effects on Self-Control in Bulimia

N/A
Recruiting
Led By Laura A Berner, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Additional Inclusion Criteria for Women with Bulimia Nervosa: Meet DSM-5 criteria for bulimia nervosa
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (at study screening)
Awards & highlights

Study Summary

This trial is looking at how fasting and eating affects self-control in women with and without bulimia nervosa. MRI will be used to collect data.

Who is the study for?
This trial is for right-handed, English-speaking women aged 18-35 who are within a certain weight range. Those with bulimia nervosa must meet specific diagnostic criteria. It's not suitable for those with medical or psychiatric conditions that could affect the study, shift workers, pregnant or lactating women, anyone allergic to meal ingredients used in the study, or individuals unable to undergo an MRI.Check my eligibility
What is being tested?
The study is looking at how fasting and eating influence self-control in females with and without bulimia nervosa by observing behavior changes and brain activity through MRIs after these states. Participants will complete computer tasks and questionnaires under both conditions.See study design
What are the potential side effects?
There may be minimal side effects from participating in this trial; however, some individuals might experience discomfort from fasting or consuming the standardized meal as well as potential anxiety or claustrophobia during MRI procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with bulimia nervosa according to DSM-5.
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I am female.
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I am between 18 and 35 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 minutes after a standardized meal
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 minutes after a standardized meal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
P(stop) at fasting state
P(stop) at fed state
Prediction errors at fasting state
+3 more
Secondary outcome measures
Frequency of Eating Disorder Symptom Episodes
Stop Signal Reaction Time (SSRT) at fasting state
Stop Signal Reaction Time (SSRT) at fed state
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants without Bulimia NervosaExperimental Treatment3 Interventions
Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
Group II: Participants with Bulimia NervosaExperimental Treatment3 Interventions
Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,416 Total Patients Enrolled
4 Trials studying Bulimia
471 Patients Enrolled for Bulimia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,707 Total Patients Enrolled
34 Trials studying Bulimia
22,113 Patients Enrolled for Bulimia
Laura A Berner, PhDPrincipal InvestigatorCenter of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai

Media Library

Self-Control (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04409457 — N/A
Bulimia Research Study Groups: Participants without Bulimia Nervosa, Participants with Bulimia Nervosa
Bulimia Clinical Trial 2023: Self-Control Highlights & Side Effects. Trial Name: NCT04409457 — N/A
Self-Control (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04409457 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the desired outcomes of this research endeavor?

"This clinical trial will measure its primary outcome, Prediction errors at fed state over a 16-hour period. Other outcomes evaluated include Stop Signal Reaction Time (SSRT) under both fasting and fed conditions, as well as the accuracy of responses to stop trials on the Stop Signal Task Performance test when in a fasted state."

Answered by AI

Is this research open to my participation?

"This medical trial requires 60 participants between 18 and 35 who are struggling with bulimia nervosa. Additionally, all patients must be female, have a body weight that is within 85 to 130% of the accepted range for their height, right-handedness, and ages that fall within 18 to 35 years."

Answered by AI

Are there still openings for participants in this research endeavor?

"Indeed, according to the clinicaltrials.gov database, this trial is actively recruiting participants after being initially posted on September 18th 2020 and last updated October 24th 2022. Therefore, 60 patients are needed at a single site."

Answered by AI

What is the capacity of this clinical trial to accept participants?

"Affirmative. The information available on clinicaltrials.gov indicates that this research project, which went live on September 18th 2020, is still recruiting patients. 60 individuals need to be signed up at a single medical centre."

Answered by AI

Is there a minimum age requirement for participants in this research?

"In accordance with the research requirements, individuals who are 18 to 35 years old have been identified as eligible participants for this clinical trial."

Answered by AI

Who else is applying?

What state do they live in?
Maine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Self-Control in Bulimia Nervosa
Laura Berner 2020. "Self-Control in Bulimia Nervosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04409457.
All > Binge Eating
~4 spots leftby Jul 2024
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