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Meditation-Based Treatment for Binge Eating Disorder

Primary Purpose

Binge Eating Disorder, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring binge eating disorder, human therapy evaluation, meditation, obesity, nutrition education, psychotherapy, racial /ethnic difference, adult human, alternative medicine, patient oriented research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of binge eating disorder; BMI at least 30; Fluent English speaker/reader; Able and willing to attend 9 weekly group sessions over two months, plus followup for 6 months, either in geographic area of Terre Haute, Indiana, or Durham, North Carolina. Exclusion Criteria: Psychiatric or other condition that would preclude appropriate group participation; On a structured diet program; Unstable related medical syndrome (e.g., diabetes, hypertension); Medication that affects weight or appetite that is still being adjusted or that is likely to change during the course of the study.

Sites / Locations

  • Indiana State University
  • Duke Center for Integrative Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 1, 2002
Last Updated
September 28, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00032760
Brief Title
Meditation-Based Treatment for Binge Eating Disorder
Official Title
Meditation-Based Treatment for Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the relative effectiveness of a mindfulness meditation-based intervention for binge eating disorder in comparison to a psycho-educational intervention and a waiting-list control group.
Detailed Description
As many as 30% of individuals seeking treatment for obesity meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for binge eating disorder (BED). BED is marked by recurrent episodes of bingeing, accompanied by feelings of loss of control, and involves chronic disregulation of physiological, emotional and behavioral systems. Meditation-based interventions have been used successfully to treat disorders with similar addictive and disregulatory characteristics, but have not been applied to treating BED. Data from an uncontrolled pilot study suggests that such an intervention can have marked immediate impact on decreasing episodes of binge eating and other associated characteristics in obese women. Therefore, this study incorporates appropriate comparison conditions to further investigate the efficacy of a mindfulness meditation-based intervention as a treatment component for treating BED symptoms. Exploratory aspects include further development of a manual, establishment of effect size (in comparison to appropriate comparison groups), inclusion of a more diverse population, and of measures that address: 1) individual differences in treatment response, 2) possible mechanisms, 3) time course of response, and 3) impact on medical/health variables. Women from two communities will be randomly assigned to 3 conditions: 1) an 8-week manualized meditation-based group intervention, 2) a psychoeducational comparison condition, or 3) a waiting-list control. Primary outcome variables will be changes in binge eating behaviors, and associated measures of depression, anxiety, self-esteem, and diet; secondary variables include medical variables sensitive to dietary change (i.e., weight; blood pressure; lipid profile; blood glucose levels), and process variables related to meditation practice, such as the Tellegen Absorption Scale, perceived value and use of the meditation practice, and experiences of increased control and awareness. Participants will be evaluated pre- and post-treatment, and at 1, 3, and 6 months followup. This data would then support the further investigation of a meditation-based intervention as part of a more comprehensive treatment program for BED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity
Keywords
binge eating disorder, human therapy evaluation, meditation, obesity, nutrition education, psychotherapy, racial /ethnic difference, adult human, alternative medicine, patient oriented research

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Meditation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of binge eating disorder; BMI at least 30; Fluent English speaker/reader; Able and willing to attend 9 weekly group sessions over two months, plus followup for 6 months, either in geographic area of Terre Haute, Indiana, or Durham, North Carolina. Exclusion Criteria: Psychiatric or other condition that would preclude appropriate group participation; On a structured diet program; Unstable related medical syndrome (e.g., diabetes, hypertension); Medication that affects weight or appetite that is still being adjusted or that is likely to change during the course of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean L. Kristeller, PhD
Organizational Affiliation
Indiana State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruth Quillian-Wolever, PhD
Organizational Affiliation
Duke University Department of Psychiatry/Center for Integrated Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana State University
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47809
Country
United States
Facility Name
Duke Center for Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22021603
Citation
Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305.
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Meditation-Based Treatment for Binge Eating Disorder

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