Bulimia Nervosa: A Biobehavioral Study (The Eating Disorder Study) (TEDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Drexel University
Sponsor:
Collaborators:
Columbia University
The Miriam Hospital
Information provided by (Responsible Party):
Michael Lowe, Drexel University
ClinicalTrials.gov Identifier:
NCT01830374
First received: March 29, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


Condition
Bulimia Nervosa

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Weight Suppression, Dieting, and Bulimia Nervosa: A Biobehavioral Study

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Purging [ Time Frame: 2 week EMA period ] [ Designated as safety issue: No ]
    Number of purging episodes recorded over two weeks.

  • Binge Eating [ Time Frame: 2 week EMA period ] [ Designated as safety issue: No ]
    Number of binge eating episodes over two week period.

  • Hormone levels [ Time Frame: Site Visit 3 (2 weeks) ] [ Designated as safety issue: No ]
    Hormone levels will be assessed approximately two weeks post-baseline at one time point.

  • Energy intake [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    RMR will be assessed at Site Visit 3, approximately two weeks post-baseline.

  • Total percent body fat [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Total percent body fat will be assessed at Site Visit 3 (approximately 2 weeks post-baseline) using dual energy x-ray absorptiometry.


Secondary Outcome Measures:
  • Body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body weight will be assessed at 6-month follow-up.

  • Psychosocial measures [ Time Frame: Site Visit-Baseline ] [ Designated as safety issue: No ]
    Psychosocial self-report measures will be given at baseline.


Estimated Enrollment: 132
Study Start Date: August 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with bulimia nervosa
This is not a treatment study. All participants will go through the same steps.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited from local university counseling centers and eating disorder centers.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Non-removal metallic object
  • Co-occurring severe mental illness
  • At risk for suicide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830374

Contacts
Contact: Jenny Gilbert, B.A. 215-553-7171 TEDS@drexel.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Esther Neustadt    215-543-5739    edru@nyspi.columbia.edu   
Contact: Lindsay Kenney    215-543-5739    edru@nyspi.columbia.edu   
Principal Investigator: Laurel Mayer, M.D.         
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jenny Gilbert, B.A.    215-553-7171    TEDS@drexel.edu   
Principal Investigator: Michael R. Lowe, Ph.D.         
Sponsors and Collaborators
Drexel University
Columbia University
The Miriam Hospital
Investigators
Principal Investigator: Michael R. Lowe, Ph.D. Drexel University
Principal Investigator: Laurel Mayer, M.D. Columbia University
  More Information

No publications provided

Responsible Party: Michael Lowe, Professor, Drexel University
ClinicalTrials.gov Identifier: NCT01830374     History of Changes
Other Study ID Numbers: 12090001548
Study First Received: March 29, 2013
Last Updated: October 2, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Drexel University:
Bulimia nervosa
Eating disorder
Weight suppression
Dieting

Additional relevant MeSH terms:
Eating Disorders
Bulimia
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014