Bulimia NervosaTEDSNCT01830374
Bulimia Nervosa: A Biobehavioral Study (The Eating Disorder Study)
An observational study of Bulimia Nervosa, run by Drexel University at 2 sites in United States.
Trial summary
The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight suppression and current dieting status in women with bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bulimia Nervosa
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be recruited from local university counseling centers and eating disorder centers.
Who may be able to join
- Diagnosis of bulimia nervosa according to the proposed DSM-V criteria
- Either currently receiving eating disorder treatment or actively seeking treatment
- BMI above 18.5 and below 30
- Not experiencing any signs of menopause
- Medically stable as determined by each site's study physician
Who cannot join
- Change in pharmacological treatment over past 4 weeks
- Currently taking atypical antipsychotic medications
- History of anorexia nervosa within the past year
- Pregnancy
- Currently taking medications that could alter hormone levels or metabolism
- Disorders affecting metabolism or hormone levels
Show all 9Show fewer
- Non-removal metallic object
- Co-occurring severe mental illness
- At risk for suicide
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
Drexel University
Philadelphia, Pennsylvania, 19104
About this study
Official title: Weight Suppression, Dieting, and Bulimia Nervosa: A Biobehavioral Study
The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight suppression and current dieting status in women with bulimia nervosa. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression, or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with bulimia nervosa, which could lead to modifications of prevailing models of bulimia nervosa and new strategies for improving treatment outcome.
Read the detailed description
Bulimia nervosa (BN) is a debilitating psychiatric disorder that primarily affects young women. Empirically supported treatments for BN have been identified but less than half of treated individuals achieve long-term remission from the disorder, possibly because current treatment approaches do not sufficiently account for variables that help maintain the disorder. Psychosocial models of BN emphasize the role of dieting as a proximal cause of binge eating and purging. Dieting has both psychological and biological facets but existing models of BN have overwhelmingly focused on its psychological impact. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression (WS), or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). Recent research has shown that WS levels in BN are elevated and that degree of WS predicts the severity of various BN characteristics and its clinical course. Studies of current dieting (CD) to lose weight have found that it is associated with reduced binge eating in BN, a finding that conflicts with prevailing models of the disorder. The proposed research will examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones) and behavioral (e.g., binge eating and purging) correlates of WS and CD in those with BN. (Relatively few of those with BN report dieting to avoid weight gain but its biological and behavioral correlates will also be examined.) The project will recruit 132 women (66 at Drexel University and 66 at Columbia University) meeting provisional Diagnostic and Statistical Manual-V diagnostic criteria for BN. The investigators will test the hypotheses that 1) CD and elevated WS will be associated with alterations in biological indices of metabolism and appetite, 2) WS will predict greater binge eating and purging, and CD will predict less binge eating, measured using Ecological Momentary Assessment (EMA), and 3) higher real time ratings of daily food restriction intentions will predict a reduced probability of binge eating during the same day but an increased probability of binge eating in subsequent days. Assessments for all participants will include: weight and reported previous highest weight (to calculate WS), the Eating Disorders Examination, 14 days of EMA to assess food restriction intentions, binge eating and purging episodes, three 24-hr food recalls, and resting energy expenditure and metabolic and appetitive hormones (including complete thyroid panel, leptin, ghrelin, cortisol and estradiol). Participants will be asked to return 6 months later for follow-up assessments of weight. This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with BN, which could lead to modifications of prevailing models of BN and new strategies for improving treatment outcome.
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia nervosa, Eating disorder, Weight suppression, Dieting
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with bulimia nervosa | This is not a treatment study. All participants will go through the same steps. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purging
Number of purging episodes recorded over two weeks.
Measured: 2 week EMA period
Binge Eating
Number of binge eating episodes over two week period.
Measured: 2 week EMA period
Hormone levels
Hormone levels will be assessed approximately two weeks post-baseline at one time point.
Measured: Site Visit 3 (2 weeks)
Energy intake
Energy intake (more specifically, energy density) will be assessed as an average of three dietary food recalls approximately three weeks post-baseline.
Measured: Three weeks
Resting metabolic rate (RMR)
RMR will be assessed at Site Visit 3, approximately two weeks post-baseline.
Measured: Two weeks
Total percent body fat
Total percent body fat will be assessed at Site Visit 3 (approximately 2 weeks post-baseline) using dual energy x-ray absorptiometry.
Measured: Two weeks
Secondary outcomes (2)
Body weight
Body weight will be assessed at 6-month follow-up.
Measured: 6 months
Psychosocial measures
Psychosocial self-report measures will be given at baseline.
Measured: Site Visit-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startAug 2012
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, The Miriam Hospital
- Responsible party
- Principal investigator, Michael Lowe, Drexel University
- Investigators
- Michael R. Lowe, Ph.D., Principal investigator, Drexel UniversityLaurel Mayer, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830374
- Sponsor's protocol ID
- 12090001548
- Acronym
- TEDS
- Status last verified
- Jul 2018
- First submitted
- 29 Mar 2013
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Suppression, Dieting, and Bulimia Nervosa: A Biobehavioral Study
- ClinicalTrials.gov ID
- NCT01830374
- Acronym / sponsor ID
- TEDS / 12090001548
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia nervosa, Eating disorder, Weight suppression, Dieting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Columbia University, The Miriam Hospital
- Study start
- Aug 2012
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight suppression and current dieting status in women with bulimia nervosa. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression, or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with bulimia nervosa, which could lead to modifications of prevailing models of bulimia nervosa and new strategies for improving treatment outcome.
Detailed description
Bulimia nervosa (BN) is a debilitating psychiatric disorder that primarily affects young women. Empirically supported treatments for BN have been identified but less than half of treated individuals achieve long-term remission from the disorder, possibly because current treatment approaches do not sufficiently account for variables that help maintain the disorder. Psychosocial models of BN emphasize the role of dieting as a proximal cause of binge eating and purging. Dieting has both psychological and biological facets but existing models of BN have overwhelmingly focused on its psychological impact. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression (WS), or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). Recent research has shown that WS levels in BN are elevated and that degree of WS predicts the severity of various BN characteristics and its clinical course. Studies of current dieting (CD) to lose weight have found that it is associated with reduced binge eating in BN, a finding that conflicts with prevailing models of the disorder. The proposed research will examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones) and behavioral (e.g., binge eating and purging) correlates of WS and CD in those with BN. (Relatively few of those with BN report dieting to avoid weight gain but its biological and behavioral correlates will also be examined.) The project will recruit 132 women (66 at Drexel University and 66 at Columbia University) meeting provisional Diagnostic and Statistical Manual-V diagnostic criteria for BN. The investigators will test the hypotheses that 1) CD and elevated WS will be associated with alterations in biological indices of metabolism and appetite, 2) WS will predict greater binge eating and purging, and CD will predict less binge eating, measured using Ecological Momentary Assessment (EMA), and 3) higher real time ratings of daily food restriction intentions will predict a reduced probability of binge eating during the same day but an increased probability of binge eating in subsequent days. Assessments for all participants will include: weight and reported previous highest weight (to calculate WS), the Eating Disorders Examination, 14 days of EMA to assess food restriction intentions, binge eating and purging episodes, three 24-hr food recalls, and resting energy expenditure and metabolic and appetitive hormones (including complete thyroid panel, leptin, ghrelin, cortisol and estradiol). Participants will be asked to return 6 months later for follow-up assessments of weight. This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with BN, which could lead to modifications of prevailing models of BN and new strategies for improving treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with bulimia nervosa | – | –This is not a treatment study. All participants will go through the same steps. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from local university counseling centers and eating disorder centers.
Key inclusion criteria (5 listed)
- Diagnosis of bulimia nervosa according to the proposed DSM-V criteria
- Either currently receiving eating disorder treatment or actively seeking treatment
- BMI above 18.5 and below 30
- Not experiencing any signs of menopause
- Medically stable as determined by each site's study physician
Key exclusion criteria (9 listed)
- Change in pharmacological treatment over past 4 weeks
- Currently taking atypical antipsychotic medications
- History of anorexia nervosa within the past year
- Pregnancy
- Currently taking medications that could alter hormone levels or metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Purging
Time frame: 2 week EMA period
Number of purging episodes recorded over two weeks.
Binge Eating
Time frame: 2 week EMA period
Number of binge eating episodes over two week period.
Hormone levels
Time frame: Site Visit 3 (2 weeks)
Hormone levels will be assessed approximately two weeks post-baseline at one time point.
Energy intake
Time frame: Three weeks
Energy intake (more specifically, energy density) will be assessed as an average of three dietary food recalls approximately three weeks post-baseline.
Resting metabolic rate (RMR)
Time frame: Two weeks
RMR will be assessed at Site Visit 3, approximately two weeks post-baseline.
Total percent body fat
Time frame: Two weeks
Total percent body fat will be assessed at Site Visit 3 (approximately 2 weeks post-baseline) using dual energy x-ray absorptiometry.
2 secondary outcomes
Body weight
Time frame: 6 months
Psychosocial measures
Time frame: Site Visit-Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Related trials for Bulimia Nervosa
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Recruiting
Neurofeedback During Eating for Bulimia Nervosa
Bulimia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R. Lowe, Ph.D. principal investigator
Drexel University
Laurel Mayer, M.D. principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bulimia Nervosa, run by Drexel University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purging (time frame: 2 week EMA period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.