An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

NCT01395355 | Completed DMC

• 1 other identifier: 1R34MH086922-01A2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating/Loss of Control Eating

Keywords

binge eating; loss of control eating; eating in the absence of hunger; emotional eating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Linking Individuals Being Emotionally Real (LIBER8)

EXPERIMENTAL

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)

Weight Management Control

ACTIVE COMPARATOR

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

Behavioral: Weight Management Control

Interventions

Linking Individuals Being Emotionally Real (LIBER8) BEHAVIORAL

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

Linking Individuals Being Emotionally Real (LIBER8)

Weight Management Control BEHAVIORAL

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

Weight Management Control

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (3)

• 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.

  PMID: 25400491 BACKGROUND

• 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.

  PMID: 23142669 BACKGROUND

• 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.

  PMID: 27299699 DERIVED

MeSH Terms

Conditions

Bulimia; Emotional Eating

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Suzanne E Mazzeo, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 15, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)