Binge Eating DisorderNCT00537758
Treatment for Obesity and Binge Eating Disorder
A study testing Cognitive Behavior Therapy, CBT and BWL and Behavioral Weight Loss Treatment in people with Binge Eating Disorder and Obesity, run by Yale University at 1 site in United States.
Trial summary
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Obesity
- What is being tested?
- Cognitive Behavior Therapy, CBT and BWL and Behavioral Weight Loss Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Binge Eating
- Overweight
Who cannot join
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Psychiatric Research at Congress Place
New Haven, Connecticut, 06519
About this study
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.
- Conditions
- Binge Eating Disorder, Obesity
- Being tested
- Cognitive Behavior Therapy, CBT and BWL, Behavioral Weight Loss Treatment
- Keywords
- binge eating disorder, cognitive behavior therapy, combination therapy, obesity, weight loss, body weight, clinical trial, dietary restriction, overeating, weight control
- Medical subject headings
- Binge-Eating Disorder, Obesity, Weight Loss, Body Weight, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
CBT and BWLBehavioural
Behavioral Weight Loss TreatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive Behavior Therapy Receives: Behavioral: Cognitive Behavior Therapy |
| 2 | Experimental | Behavioral Weight Loss Treatment Receives: Behavioral: Behavioral Weight Loss Treatment |
| 3 | Experimental | CBT + BWL Receives: Behavioral: CBT and BWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating
BMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Carlos M. Grilo, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537758
- Sponsor's protocol ID
- 0204015334
- Other IDs
- R01DK049587
- Status last verified
- Sep 2007
- First submitted
- 27 Sep 2007
- Last updated
- 31 Mar 2020
- Results posted
- No
Publications
Grilo CM, Pittman B. Exploring Dietary Restraint as a Mediator of Behavioral and Cognitive-Behavioral Treatments on Outcomes for Patients With Binge-Eating Disorder With Obesity. Int J Eat Disord. 2024 Dec;57(12):2475-2481. doi: 10.1002/eat.24288. Epub 2024 Sep 9.
PubMed 39247962
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Obesity and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT00537758
- Acronym / sponsor ID
- 0204015334
- Conditions
- Binge Eating Disorder, Obesity
- Keywords
- binge eating disorder, cognitive behavior therapy, combination therapy, obesity, weight loss, body weight, clinical trial, dietary restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2002
- First posted
- 1 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavior TherapyCognitive Behavior Therapy |
| 2 | Experimental | Behavioral: Behavioral Weight Loss TreatmentBehavioral Weight Loss Treatment |
| 3 | Experimental | Behavioral: CBT and BWLCBT + BWL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Binge Eating
- Overweight
Key exclusion criteria (3 listed)
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy | Behavioural | 1 |
| CBT and BWL | Behavioural | 3 |
| Behavioral Weight Loss Treatment | Behavioural | 2 |
Primary outcome
Binge Eating
BMI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 39247962Grilo CM, Pittman B. Exploring Dietary Restraint as a Mediator of Behavioral and Cognitive-Behavioral Treatments on Outcomes for Patients With Binge-Eating Disorder With Obesity. Int J Eat Disord. 2024 Dec;57(12):2475-2481. doi: 10.1002/eat.24288. Epub 2024 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos M. Grilo, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy, CBT and BWL and Behavioral Weight Loss Treatment in people with Binge Eating Disorder and Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.