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An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

Primary Purpose

Binge Eating/Loss of Control Eating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linking Individuals Being Emotionally Real (LIBER8)
Weight Management Control
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating/Loss of Control Eating focused on measuring binge eating, loss of control eating, eating in the absence of hunger, emotional eating

Eligibility Criteria

13 Years - 22 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Linking Individuals Being Emotionally Real (LIBER8)

Weight Management Control

Arm Description

Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.

Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral weight management techniques.

Outcomes

Primary Outcome Measures

Changes in frequency of episodes of loss of control and/or binge eating from baseline to three 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.
Changes in depressive symptoms from baseline to three month follow-up.
Changes in anxiety symptoms from baseline to three month follow-up.
Changes in health-related quality of life (including social, emotional, school, and physical functioning) from baseline to three month follow-up.
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.
Changes in impulsive behaviors from baseline to three month follow-up.
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.
Height and Weight
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.

Full Information

First Posted
June 30, 2011
Last Updated
May 6, 2015
Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01395355
Brief Title
An Integrative Intervention for Loss of Control Eating Among Adolescent Girls
Official Title
An Integrative Intervention for Binge Eating Among Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating/Loss of Control Eating
Keywords
binge eating, loss of control eating, eating in the absence of hunger, emotional eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linking Individuals Being Emotionally Real (LIBER8)
Arm Type
Experimental
Arm Description
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
Arm Title
Weight Management Control
Arm Type
Active Comparator
Arm Description
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral weight management techniques.
Intervention Type
Behavioral
Intervention Name(s)
Linking Individuals Being Emotionally Real (LIBER8)
Intervention Description
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
Intervention Type
Behavioral
Intervention Name(s)
Weight Management Control
Intervention Description
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Changes in depressive symptoms from baseline to three month follow-up.
Time Frame
3-Month Follow-up
Title
Changes in anxiety symptoms from baseline to three month follow-up.
Time Frame
3-Month Follow-up
Title
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
Title
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.
Time Frame
3-Month Follow-up
Title
Changes in impulsive behaviors from baseline to three month follow-up.
Time Frame
3-Month Follow-up
Title
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.
Time Frame
3-Month Follow-up
Title
Height and Weight
Time Frame
3-Month Follow-up
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne E Mazzeo, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25400491
Citation
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.
Results Reference
background
PubMed Identifier
23142669
Citation
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.
Results Reference
background
PubMed Identifier
27299699
Citation
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.
Results Reference
derived

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An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

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