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An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

This study is currently recruiting participants.
Verified June 2012 by Virginia Commonwealth University
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01395355
First received: June 30, 2011
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. The investigators hypothesize that this intervention will serve to reduce binge and LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, and impulsivity, and improved quality of life.


Condition Intervention
Loss of Control Eating
Binge Eating
 Behavioral: Linking Individuals Being Emotionally Real (LIBER8)
Behavioral: Weight Management Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Integrative Intervention for Binge Eating Among Adolescent Girls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in depressive symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in anxiety symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in health-related quality of life (including social, emotional, school, and physical functioning) from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in impulsive behaviors from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Height and Weight [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]
  • Changes in the frequency of eating as a means of coping with negative emotions, such as anger, sadness and anxiety, from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linking Individuals Being Emotionally Real (LIBER8)
Participants will attend a 12-14 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
 Behavioral: Linking Individuals Being Emotionally Real (LIBER8)
Participants will attend a 12-14 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
Active Comparator: Weight Management Control
Participants will attend a 12-14 week, 1-2 hours long intervention comprised of behavioral weight management techniques.
 Behavioral: Weight Management Control
Participants will attend a 12-14 week, 1-2 hours long intervention comprised of behavioral techniques.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • currently meeting criteria for loss of control (LOC) eating or binge eating disorder (BED) as defined by Marcus and Kalarchian
  • age 13-18
  • female
  • lives with parent/primary caregiver most of the time

Exclusion Criteria:

  • alcohol or drug dependence in the last three months
  • current suicidal intent or clinically significant self-harm behaviors reported during the assessment
  • diagnosis of bulimia nervosa or anorexia nervosa in the last three months
  • presence of a developmental disability or neurological impairment that would impair the individual's ability to participate in the intervention
  • psychosis, including schizophrenia, or bipolar I disorder
  • not fluent in English (participant and parents/primary caregivers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395355

Contacts
Contact: Nichole R Kelly, M.S. 804.827.9244 nrkelly@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Principal Investigator: Suzanne Mazzeo, PhD            
Sponsors and Collaborators
Virginia Commonwealth University
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Suzanne E Mazzeo, PhD Virginia Commonwealth University
  More Information

No publications provided by Virginia Commonwealth University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01395355     History of Changes
Other Study ID Numbers: 1R34MH086922-01A2, 1R34MH086922-01A2
Study First Received: June 30, 2011
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
binge eating
loss of control eating
eating in the absence of hunger
emotional eating

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Hyperphagia
Signs and Symptoms, Digestive
 Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013