An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

This study has been completed.

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: May 6, 2015

Last verified: May 2015

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


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

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 ]

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 ]
Changes in depressive symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
Changes in anxiety symptoms from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
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 ]
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
Changes in impulsive behaviors from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up. [ Time Frame: 3-Month Follow-up ]
Height and Weight [ Time Frame: 3-Month Follow-up ]
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 ]


Enrollment:	59
Study Start Date:	August 2011
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

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: 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:

Palmberg AA, Stern M, Kelly NR, Bulik C, Belgrave FZ, Trapp SK, Hofmeier SM, Mazzeo SE. Adolescent Girls and Their Mothers Talk About Experiences of Binge and Loss of Control Eating. J Child Fam Stud. 2014 Nov;23(8):1403-1416.

Mazzeo SE, Kelly NR, Stern M, Palmberg AA, Belgrave FZ, Tanofsky-Kraff M, Latzer Y, Bulik CM. LIBER8 design and methods: an integrative intervention for loss of control eating among African American and White adolescent girls. Contemp Clin Trials. 2013 Jan;34(1):174-85. doi: 10.1016/j.cct.2012.10.012. Epub 2012 Nov 9.


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01395355 History of Changes
Other Study ID Numbers:	1R34MH086922-01A2 ( US NIH Grant/Contract Award Number )
Study First Received:	June 30, 2011
Last Updated:	May 6, 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

ClinicalTrials.gov processed this record on May 25, 2017

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