An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Binge Eating/Loss of Control Eating	Behavioral: Linking Individuals Being Emotionally Real (LIBER8); Behavioral: Weight Management Control	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

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

Mazzeo SE, Lydecker J, Harney M, Palmberg AA, Kelly NR, Gow RW, Bean MK, Thornton LM, Tanofsky-Kraff M, Bulik CM, Latzer Y, Stern M. Development and preliminary effectiveness of an innovative treatment for binge eating in racially diverse adolescent girls. Eat Behav. 2016 Aug;22:199-205. doi: 10.1016/j.eatbeh.2016.06.014. Epub 2016 Jun 3.

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
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