NCT00032760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

October 2, 2007

Status Verified

September 1, 2007

First QC Date

April 1, 2002

Last Update Submit

September 28, 2007

Conditions

Binge Eating DisorderObesity

Keywords

binge eating disorderhuman therapy evaluationmeditationobesitynutrition educationpsychotherapyracial /ethnic differenceadult humanalternative medicinepatient oriented research

Interventions

MeditationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana State University

Terre Haute, Indiana, 47809, United States

Location

Duke Center for Integrative Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 22021603BACKGROUND

MeSH Terms

Conditions

Binge-Eating DisorderObesity

Interventions

Meditation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jean L. Kristeller, PhD

    Indiana State University

    PRINCIPAL INVESTIGATOR

  • Ruth Quillian-Wolever, PhD

    Duke University Department of Psychiatry/Center for Integrated Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 1, 2002

First Posted

April 2, 2002

Study Start

March 1, 2002

Study Completion

March 1, 2004

Last Updated

October 2, 2007

Record last verified: 2007-09

Locations

US(2)