Trial · NCT03063606
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
NCT03063606, Phase 2, Phase 3, Completed, Yale University; results first posted 2023-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment. Trials, record NCT03063606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03063606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
- NCT number
- NCT03063606
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Binge-Eating Disorder, Obesity
- Interventions
- Cognitive-Behavioral Therapy (CBT), NB Medication (on-going from acute treatment)
- First posted
- 2017-02-24
- Last updated
- 2024-02-01
- Results first posted
- 2023-07-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Binge Eating Frequency (Continuous) | Post-treatment (4 months) | Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously. |
| Primary | Change in Body Mass Index at 4 Months Post-Treatment From Baseline | Baseline and Post-treatment (4 months) | BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline |
| Secondary | Binge Eating Frequency (Continuous) | 6-Month Follow-up | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| Secondary | Binge Eating Frequency (Continuous) | 12-Month Follow-up | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| Other | Body Mass Index | 12-Month Follow-up | BMI is calculated using measured height and weight (e.g., percent loss). |
| Other | Body Mass Index | 6-Month Follow-up | BMI is calculated using measured height and weight (e.g., percent loss). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Binge Eating Frequency (Continuous) | Post-treatment (4 months) | Eating events/28 days | MEAN | |
| PRIMARY | Change in Body Mass Index at 4 Months Post-Treatment From Baseline | Baseline and Post-treatment (4 months) | Kg/m^2 | MEAN | |
| SECONDARY | Binge Eating Frequency (Continuous) | 6-Month Follow-up | eating events/28 days | MEAN | |
| SECONDARY | Binge Eating Frequency (Continuous) | 12-Month Follow-up | No participants in the on-going blinded pharmacotherapy group completed the 12-month follow-up assessment. | eating events/28 days | MEAN |
| OTHER_PRE_SPECIFIED | Body Mass Index | 12-Month Follow-up | There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study. | ||
| OTHER_PRE_SPECIFIED | Body Mass Index | 6-Month Follow-up | There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study. |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Binge Eating Frequency (Continuous) | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 0.8 | Standard Deviation 1.6 | Eating events/28 days | |
| Binge Eating Frequency (Continuous) | On-going Blinded Pharmacotherapy | 12.1 | Standard Deviation 9.9 | Eating events/28 days | |
| Change in Body Mass Index at 4 Months Post-Treatment From Baseline | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | -0.16 | Standard Deviation 4.27 | Kg/m^2 | |
| Change in Body Mass Index at 4 Months Post-Treatment From Baseline | On-going Blinded Pharmacotherapy | -1.18 | Standard Deviation 4.35 | Kg/m^2 | |
| Binge Eating Frequency (Continuous) | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 2.80 | Standard Deviation 6.56 | eating events/28 days | |
| Binge Eating Frequency (Continuous) | On-going Blinded Pharmacotherapy | 3 | eating events/28 days | ||
| Binge Eating Frequency (Continuous) | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 1.70 | Standard Deviation 2.54 | eating events/28 days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 18 | |
| Overall Study | STARTED | On-going Blinded Pharmacotherapy | 13 | |
| Overall Study | COMPLETED | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 16 | |
| Overall Study | COMPLETED | On-going Blinded Pharmacotherapy | 10 | |
| Overall Study | NOT COMPLETED | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | 2 | |
| Overall Study | NOT COMPLETED | On-going Blinded Pharmacotherapy | 3 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (NB) | 1 | 15 | |
| other | Constipation | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (Placebo) | 1 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (NB) | 2 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (Placebo) | 1 | 16 | |
| other | Nausea | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (NB) | 1 | 15 | |
| other | Nausea | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (Placebo) | 2 | 16 | |
| other | Vomiting | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (NB) | 1 | 15 | |
| other | Vomiting | Gastrointestinal disorders | On-going Blinded Pharmacotherapy (Placebo) | 0 | 16 | |
| other | Dizziness | General disorders | On-going Blinded Pharmacotherapy (NB) | 0 | 15 | |
| other | Dizziness | General disorders | On-going Blinded Pharmacotherapy (Placebo) | 1 | 16 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | On-going Blinded Pharmacotherapy (NB) | 0 | 15 |
| Total, all-cause mortality | On-going Blinded Pharmacotherapy (Placebo) | 0 | 16 |
| Total, other adverse events | On-going Blinded Pharmacotherapy (NB) | 3 | 15 |
| Total, other adverse events | On-going Blinded Pharmacotherapy (Placebo) | 5 | 16 |
| Total, serious adverse events | On-going Blinded Pharmacotherapy (NB) | 0 | 15 |
| Total, serious adverse events | On-going Blinded Pharmacotherapy (Placebo) | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK049587 | Behavioral and Pharmacologic Treatment of Binge Eating and Obesity | GRILO, CARLOS M | YALE UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2002 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| On-going Blinded Pharmacotherapy (NB) vs On-going Blinded Pharmacotherapy (Placebo): deaths from any cause | Trial comparisons |
| On-going Blinded Pharmacotherapy (NB) vs On-going Blinded Pharmacotherapy (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03063606
GET https://conductscience.org/api/trials/v1/NCT03063606/registered