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An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

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ClinicalTrials.gov Identifier: NCT01395355
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : May 8, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Binge Eating/Loss of Control Eating Behavioral: Linking Individuals Being Emotionally Real (LIBER8) Behavioral: Weight Management Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Integrative Intervention for Binge Eating Among Adolescent Girls
Study Start Date : August 2011
Primary Completion Date : December 2014
Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Linking Individuals Being Emotionally Real (LIBER8)
Participants will attend a 8-12 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 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
Active Comparator: Weight Management Control
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral weight management techniques.
Behavioral: Weight Management Control
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in depressive symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
  3. Changes in anxiety symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
  4. 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 ]
  5. Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
  6. Changes in impulsive behaviors from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
  7. Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
  8. Height and Weight [ Time Frame: 3-Month Follow-up ]
  9. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes 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 13-22
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395355


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
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

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01395355     History of Changes
Other Study ID Numbers: 1R34MH086922-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

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
Feeding and Eating Disorders
Mental Disorders