Binge Eating/Loss of Control Eating Clinical Trial
Official title:
An Integrative Intervention for Binge Eating Among Adolescent Girls
| Verified date | May 2015 |
| Source | Virginia Commonwealth University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 13 Years to 22 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Virginia Commonwealth University | Richmond | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Virginia Commonwealth University | National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill |
United States,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up | 3-Month Follow-up | No | |
| Secondary | Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | Changes in depressive symptoms from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | Changes in anxiety symptoms from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | 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 | No | |
| Secondary | Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | Changes in impulsive behaviors from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up. | 3-Month Follow-up | No | |
| Secondary | Height and Weight | 3-Month Follow-up | No | |
| Secondary | 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 | No |