An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

NCT ID: NCT01395355

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Binge Eating/Loss of Control Eating

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Linking Individuals Being Emotionally Real (LIBER8)

Intervention Type BEHAVIORAL

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

Weight Management Control

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

Group Type ACTIVE_COMPARATOR

Weight Management Control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Weight Management Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

22 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzanne E Mazzeo, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25400491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23142669 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27299699 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R34MH086922-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34MH086922-01A2

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eating Behavior in Adolescents
NCT00631644 COMPLETED
Treatment of Binge Eating Disorder
NCT00041743 COMPLETED NA
Treatment of Binge Eating Disorder
NCT00039936 COMPLETED NA