NCT00601653

Brief Summary

This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

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

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

January 23, 2008

Last Update Submit

March 31, 2020

Conditions

Binge Eating DisorderObesityOverweight

Keywords

Binge Eating DisorderBEDNutritionEnergy DensityCognitive Behavioral TherapyCBT

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Measured at Year 1

Secondary Outcomes (3)

  • Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning)

    Measured at Year 1

  • Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger)

    Measured at Year 1

  • Health status (e.g., lipid profile, blood pressure)

    Measured at Year 1

Study Arms (2)

1

ACTIVE COMPARATOR

Cognitive behavioral therapy plus general nutrition counseling

Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)

2

EXPERIMENTAL

Cognitive behavioral therapy plus low energy density diet counseling

Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)

Interventions

Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)BEHAVIORAL

CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.

1
Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)BEHAVIORAL

CBT+LED includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling that centers upon eating higher volumes of low-calorie foods.

2

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) greater than or equal to 30
  • Meets DSM-IV criteria for BED

You may not qualify if:

  • Co-existing physical and/or psychiatric conditions that require different treatments than CBT (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
  • Meets criteria for current substance abuse or dependence
  • Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
  • Any physical conditions, such as diabetes, known to affect weight or eating
  • Pregnant, breastfeeding, or plans to become pregnant during the treatment period
  • Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
  • Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Masheb RM, Grilo CM, Rolls BJ. A randomized controlled trial for obesity and binge eating disorder: low-energy-density dietary counseling and cognitive-behavioral therapy. Behav Res Ther. 2011 Dec;49(12):821-9. doi: 10.1016/j.brat.2011.09.006. Epub 2011 Sep 28.

    PMID: 22005587RESULT

MeSH Terms

Conditions

Binge-Eating DisorderObesityOverweight

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robin M. Masheb, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

January 28, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 2, 2020

Record last verified: 2020-03