Binge Eating DisorderNCT00601653
Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
A study testing Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) and Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED) in people with Binge Eating Disorder and Obesity, run by Yale University.
Trial summary
This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Binge Eating Disorder, Obesity, Overweight
- What is being tested?
- Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) and Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Mar 2010
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) greater than or equal to 30
- Meets DSM-IV criteria for BED
Who cannot join
- 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)
About this study
Official title: CBT and Dieting: Effects on Psychopathology and Weight in BED
This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.
Read the detailed description
Binge eating disorder (BED) is one of the most common eating disorders, with millions of affected Americans. The majority of people who binge eat are mildly to severely overweight, but people of normal weight can also have BED. People with BED frequently eat excessive amounts of food in a short period of time, often feeling a loss of control over their urge to eat. Following a binge eating episode, the person usually experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the psychological distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain, including high blood pressure, diabetes, heart disease, high cholesterol, and stroke. Previous studies on BED have found cognitive behavioral therapy (CBT) to be the most effective treatment in improving binge eating habits, attitudinal features of eating disorders, and psychological functioning. However, CBT alone has not been nearly as effective in producing clinically significant weight loss in those who are overweight. This study will evaluate the effectiveness of adding nutritional counseling to CBT in treating obese people with BED.
Participants in this 1-year study will be randomly assigned to one of two treatment groups: CBT plus general nutrition counseling (CBT+GN) or CBT plus low energy density diet counseling (CBT+LED). All participants will receive 21 hourly individual treatment sessions over a 6-month period. Sessions will be weekly for Weeks 1 to 16 and every other week for Weeks 17 to 26. Each treatment session will include 40 minutes of CBT and 20 minutes of nutritional counseling (GN or LED). Assessments will include interviews and questionnaires about symptoms and height and weight measurements. These assessments will occur at baseline, monthly during treatment, and at 6 months post-treatment. At the end of treatment, participants will also have blood drawn to determine lipid levels and will be asked to complete two food intake interviews by phone.
- Conditions
- Binge Eating Disorder, Obesity, Overweight
- Being tested
- Cognitive behavioral therapy plus general nutrition counseling (CBT+GN), Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
- Keywords
- Binge Eating Disorder, BED, Nutrition, Energy Density, Cognitive Behavioral Therapy, CBT
- Medical subject headings
- Binge-Eating Disorder, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)Behavioural
CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.
Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cognitive behavioral therapy plus general nutrition counseling Receives: Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) |
| 2 | Experimental | Cognitive behavioral therapy plus low energy density diet counseling Receives: Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 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: Measured at Year 1
Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger)
Measured: Measured at Year 1
Health status (e.g., lipid profile, blood pressure)
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2010
- Study completionMar 2010
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Robin M. Masheb, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601653
- Sponsor's protocol ID
- 0706002747
- Other IDs
- 5R21MH082629, DATR A2-AID
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2008
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22005587
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT and Dieting: Effects on Psychopathology and Weight in BED
- ClinicalTrials.gov ID
- NCT00601653
- Acronym / sponsor ID
- 0706002747
- Conditions
- Binge Eating Disorder, Obesity, Overweight
- Keywords
- Binge Eating Disorder, BED, Nutrition, Energy Density, Cognitive Behavioral Therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Jan 2008 (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 will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.
Detailed description
Binge eating disorder (BED) is one of the most common eating disorders, with millions of affected Americans. The majority of people who binge eat are mildly to severely overweight, but people of normal weight can also have BED. People with BED frequently eat excessive amounts of food in a short period of time, often feeling a loss of control over their urge to eat. Following a binge eating episode, the person usually experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the psychological distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain, including high blood pressure, diabetes, heart disease, high cholesterol, and stroke. Previous studies on BED have found cognitive behavioral therapy (CBT) to be the most effective treatment in improving binge eating habits, attitudinal features of eating disorders, and psychological functioning. However, CBT alone has not been nearly as effective in producing clinically significant weight loss in those who are overweight. This study will evaluate the effectiveness of adding nutritional counseling to CBT in treating obese people with BED.
Participants in this 1-year study will be randomly assigned to one of two treatment groups: CBT plus general nutrition counseling (CBT+GN) or CBT plus low energy density diet counseling (CBT+LED). All participants will receive 21 hourly individual treatment sessions over a 6-month period. Sessions will be weekly for Weeks 1 to 16 and every other week for Weeks 17 to 26. Each treatment session will include 40 minutes of CBT and 20 minutes of nutritional counseling (GN or LED). Assessments will include interviews and questionnaires about symptoms and height and weight measurements. These assessments will occur at baseline, monthly during treatment, and at 6 months post-treatment. At the end of treatment, participants will also have blood drawn to determine lipid levels and will be asked to complete two food intake interviews by phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)Cognitive behavioral therapy plus general nutrition counseling |
| 2 | Experimental | Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)Cognitive behavioral therapy plus low energy density diet counseling |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) greater than or equal to 30
- Meets DSM-IV criteria for BED
Key exclusion criteria (7 listed)
- 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
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 behavioral therapy plus general nutrition counseling (CBT+GN)CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling. | Behavioural | 1 |
| Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)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. | Behavioural | 2 |
Primary outcome
Weight loss
Time frame: Measured at Year 1
3 secondary outcomes
Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning)
Time frame: Measured at Year 1
Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger)
Time frame: Measured at Year 1
Health status (e.g., lipid profile, blood pressure)
Time frame: Measured at Year 1
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 2 Apr 2020.
- Results publication: PubMed 22005587Masheb 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.
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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.
Robin M. Masheb, PhD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) and Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED) in people with Binge Eating Disorder and Obesity, run by Yale University.
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 7 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight loss (time frame: Measured at Year 1). 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 NCT00601653, 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 2 Apr 2020.