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
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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 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 |
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.
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 13 Years to 22 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23284 |
Principal Investigator: | Suzanne E Mazzeo, PhD | Virginia Commonwealth University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |