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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT01830374
Study groupRoleWhat they receive
Women with bulimia nervosaThis 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.

  1. Purging

    Number of purging episodes recorded over two weeks.

    Measured: 2 week EMA period

  2. Binge Eating

    Number of binge eating episodes over two week period.

    Measured: 2 week EMA period

  3. Hormone levels

    Hormone levels will be assessed approximately two weeks post-baseline at one time point.

    Measured: Site Visit 3 (2 weeks)

  4. 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

  5. Resting metabolic rate (RMR)

    RMR will be assessed at Site Visit 3, approximately two weeks post-baseline.

    Measured: Two weeks

  6. 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)
  1. Body weight

    Body weight will be assessed at 6-month follow-up.

    Measured: 6 months

  2. 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.

  1. First posted12 Apr 2013 (estimated)
  2. Study startAug 2012
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

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)
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

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.

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