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Completed

NCT Number: NCT01395355

An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

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.

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Key information

Conditions

Binge Eating/Loss of Control Eating Behavior Bulimia Emotional Eating Feeding Behavior Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–22 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Weight Management Control

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Changes in depressive symptoms from baseline to three month follow-up.

    Time frame: 3-Month Follow-up

  3. Changes in anxiety symptoms from baseline to three month follow-up.

    Time frame: 3-Month Follow-up

  4. 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

  5. Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.

    Time frame: 3-Month Follow-up

  6. Changes in impulsive behaviors from baseline to three month follow-up.

    Time frame: 3-Month Follow-up

  7. Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.

    Time frame: 3-Month Follow-up

  8. Height and Weight

    Time frame: 3-Month Follow-up

  9. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

An Integrative Intervention for Binge Eating Among Adolescent Girls

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2011
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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