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An Integrative Intervention for Loss of Control Eating Among Adolescent Girls
This study has been completed.
Sponsor:
Virginia Commonwealth University
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
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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 (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
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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
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:
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01395355 History of Changes |
| Other Study ID Numbers: |
1R34MH086922-01A2 ( U.S. NIH Grant/Contract ) |
| 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 September 21, 2017