An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

An Integrative Intervention for Binge Eating Among Adolescent Girls

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.

Study Overview

• Status: Completed
• Conditions: Binge Eating/Loss of Control Eating
• Intervention / Treatment: Behavioral: Linking Individuals Being Emotionally Real (LIBER8); Behavioral: Weight Management Control

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 22 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up	3-Month Follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up.	3-Month Follow-up
Changes in depressive symptoms from baseline to three month follow-up.	3-Month Follow-up
Changes in anxiety symptoms from baseline to three month follow-up.	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.	3-Month Follow-up
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.	3-Month Follow-up
Changes in impulsive behaviors from baseline to three month follow-up.	3-Month Follow-up
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.	3-Month Follow-up
Height and Weight	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.	3-Month Follow-up

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Mental Health (NIMH); University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Suzanne E Mazzeo, PhD, Virginia Commonwealth University

Publications and helpful links

General 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. doi: 10.1007/s10826-013-9797-z.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: emotional eating; binge eating; loss of control eating; eating in the absence of hunger
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Binge-Eating Disorder
• Other Study ID Numbers: 1R34MH086922-01A2 (U.S. NIH Grant/Contract)