NCT01830374

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

March 29, 2013

Last Update Submit

July 27, 2018

Conditions

Bulimia Nervosa

Keywords

Bulimia nervosaEating disorderWeight suppressionDieting

Outcome Measures

Primary Outcomes (6)

  • Purging

    Number of purging episodes recorded over two weeks.

    2 week EMA period

  • Binge Eating

    Number of binge eating episodes over two week period.

    2 week EMA period

  • Hormone levels

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

    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.

    Three weeks

  • Resting metabolic rate (RMR)

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

    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.

    Two weeks

Secondary Outcomes (2)

  • Body weight

    6 months

  • Psychosocial measures

    Site Visit-Baseline

Study Arms (1)

Women with bulimia nervosa

This is not a treatment study. All participants will go through the same steps.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bulimia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R. Lowe, Ph.D.

    Drexel University

    PRINCIPAL INVESTIGATOR

  • Laurel Mayer, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 12, 2013

Study Start

August 1, 2012

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

US(2)