Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK117072 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yale University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.
In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBT Weight Loss Therapy for BED | Experimental | Acceptance-Based Behavioral Weight Loss Therapy for BED |
|
| Standard Behavior Therapy | Active Comparator | Standard Behavioral Weight Loss Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance-Based Behavioral Weight Loss Therapy for BED | Behavioral | ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline). | Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Eating Disorder Examination Questionnaire | The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint. Assessing changes in EDE Global score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University, Stratton Hall | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABBT Weight Loss Therapy for BED | Acceptance-Based Behavioral Weight Loss Therapy for BED Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. |
| FG001 | Standard Behavior Therapy | Standard Behavioral Weight Loss Therapy Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABBT Weight Loss Therapy for BED | Acceptance-Based Behavioral Weight Loss Therapy for BED Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline). | Posted | Mean | Standard Deviation | percentage of weight loss | Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment) |
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABBT Weight Loss Therapy for BED | Acceptance-Based Behavioral Weight Loss Therapy for BED Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adrienne Juarascio | Drexel University | 215-553-7154 | adrienne.s.juarascio@drexel.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2017 | Mar 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2024 | Mar 27, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D056912 | Binge-Eating Disorder |
| D015431 | Weight Loss |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001513 | Beds |
| ID | Term |
|---|---|
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
Not provided
Not provided
The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.
Not provided
Not provided
Not provided
| Standard Behavior Therapy | Behavioral | SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. |
|
| Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline) |
| Standard Behavior Therapy |
Standard Behavioral Weight Loss Therapy Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Missing data for two participants from ABT and two participants from SBT. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline EDE Global Score | Measure Description: The Eating Disorder Examination (EDE) is a diagnostic interview for the assessment of eating disorder symptoms, including binge eating frequency, compensatory behavior frequency, and global eating pathology. The EDE yields a global score and four subscale scores (Restraint, Eating concern, Shape concern, Weight concern), with higher scores indicating greater severity of eating disorder pathology. To obtain the global score, the subscale scores (which range from 0 to 6) are summed, and the resulting total is divided by the number of subscales (i.e. four). | Mean | Standard Deviation | scores on a scale |
|
Standard Behavioral Weight Loss Therapy Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. |
|
|
| Secondary | Eating Disorder Examination Questionnaire | The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint. Assessing changes in EDE Global score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline) |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Standard Behavior Therapy | Standard Behavioral Weight Loss Therapy Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. | 0 | 63 | 0 | 63 | 0 | 63 |
Not provided
Not provided
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D006963 | Hyperphagia |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 Year Follow-Up |
|