Binge-Eating DisorderNCT03777189
Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
A study testing Cognitive-Behavioral Therapy in people with Binge-Eating Disorder and Binge Eating, run by Yale University at 1 site in United States.
Trial summary
This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge-Eating Disorder, Binge Eating, Overweight and Obesity
- What is being tested?
- Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 3 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old;
- Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
- BMI 25-45 kg/m2;
- Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
- Available for the duration of the treatment and follow-up (7 months);
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
Who cannot join
- Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
- Reports active suicidal or homicidal ideation.
- Current anorexia or bulimia nervosa.
- Contraindications to physical activity.
- Blood pressure >140 systolic or >90 diastolic.
- Breast-feeding or pregnant, or planning to become pregnant during the study.
Show all 10Show fewer
- History of stroke or myocardial infarction.
- Current or recent (within 12 months) drug or alcohol dependence
- Currently receiving effective treatment for eating or weight loss.
- Currently participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.
- Conditions
- Binge-Eating Disorder, Binge Eating, Overweight and Obesity
- Being tested
- Cognitive-Behavioral Therapy
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity. Receives: Behavioral: Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge-eating frequency
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Measured: Post-treatment (4 months)
Body mass index
BMI is calculated using measured height and weight (e.g., percent loss)
Measured: Post-treatment (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start5 Dec 2018
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Why it stopped: benefits of treatment less than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Grilo, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777189
- Sponsor's protocol ID
- 2000023412
- Status last verified
- Oct 2019
- First submitted
- 13 Dec 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
- ClinicalTrials.gov ID
- NCT03777189
- Acronym / sponsor ID
- 2000023412
- Conditions
- Binge-Eating Disorder, Binge Eating, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: benefits of treatment less than expected
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 17 Dec 2018 (actual)
- 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 aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral TherapyCognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 65 years old;
- Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
- BMI 25-45 kg/m2;
- Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
- Available for the duration of the treatment and follow-up (7 months);
Key exclusion criteria (10 listed)
- Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
- Reports active suicidal or homicidal ideation.
- Current anorexia or bulimia nervosa.
- Contraindications to physical activity.
- Blood pressure >140 systolic or >90 diastolic.
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 TherapyCognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity. | Behavioural | Cognitive-Behavioral Therapy |
Primary outcome
Binge-eating frequency
Time frame: Post-treatment (4 months)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body mass index
Time frame: Post-treatment (4 months)
BMI is calculated using measured height and weight (e.g., percent loss)
Results and safety
The study was stopped early (reason given: benefits of treatment less than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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 Grilo 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-Behavioral Therapy in people with Binge-Eating Disorder and Binge Eating, 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Oct 2019. 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 was stopped early (reason given: benefits of treatment less than expected). Results are not available in the source record.
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 frequency (time frame: Post-treatment (4 months)). 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?
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 10 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.