Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:53 AM
Study NCT ID:
NCT00032760
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
2002-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation-Based Treatment for Binge Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-28', 'studyFirstSubmitDate': '2002-04-01', 'studyFirstSubmitQcDate': '2002-04-01', 'lastUpdatePostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['binge eating disorder', 'human therapy evaluation', 'meditation', 'obesity', 'nutrition education', 'psychotherapy', 'racial /ethnic difference', 'adult human', 'alternative medicine', 'patient oriented research'], 'conditions': ['Binge Eating Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '22021603', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWomen 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of binge eating disorder;\n* BMI at least 30;\n* Fluent English speaker/reader;\n* 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.\n\nExclusion Criteria:\n\n* Psychiatric or other condition that would preclude appropriate group participation;\n* On a structured diet program;\n* Unstable related medical syndrome (e.g., diabetes, hypertension);\n* Medication that affects weight or appetite that is still being adjusted or that is likely to change during the course of the study.'}, 'identificationModule': {'nctId': 'NCT00032760', 'briefTitle': 'Meditation-Based Treatment for Binge Eating Disorder', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Meditation-Based Treatment for Binge Eating Disorder', 'orgStudyIdInfo': {'id': 'R21AT000416-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT000416-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47809', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana State University', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Integrative Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Jean L. Kristeller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana State University'}, {'name': 'Ruth Quillian-Wolever, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Department of Psychiatry/Center for Integrated Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}