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| ID | Type | Description | Link |
|---|---|---|---|
| 5K76AG060003 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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Twenty women, ages 60 or older, will be consented and enrolled in a single-arm, pilot implementation trial of the age-tailored cognitive-behavioral based BE intervention. Participants will complete assessments at baseline, post-intervention, and at two follow-up timepoints; weekly BE frequency will be collected to monitor progress during the intervention period.
The intervention being studied will be an age-tailored, cognitive-behavioral therapy (CBT) based behavioral intervention for binge eating (BE), delivered by the PI, a licensed clinical psychologist, in small group format (4-6 participants per group) over 12-16 weeks. The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. The final session number, frequency, content, and timeline will be determined during intervention-tailoring process not a part of this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BESTOW behavioral intervention | Experimental | The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binge Eating Syndrome Treatment (BESTOW) | Behavioral | The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Usage Rating Profile - Intervention | Score on the Feasibility Usage Rating Profile. This scale gathers patient reported feasibility of the intervention (e.g., time needed, quality of materials, simplicity of the intervention) to be completed after doing the intervention. This scale has six items; total scores range from 1-6 and a higher scores indicate greater feasibility. | 6 weeks (post), and 2 month follow-up |
| Acceptability - Usage Rating Profile - Intervention | Score on the Acceptability Usage Rating Profile scale which gathers participant ratings of how acceptable the treatment is for targeting binge eating (e.g., how helpful the intervention was, how much they liked it, willingness to do the intervention) to be completed after doing the intervention. This scale has eight items; total scores range from 1-6, a higher score indicates greater acceptability. | 6 weeks (post), and 2 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating Score (BES) | Change in score on the BES survey. The BES is a 16-item, self-report survey that assess binge eating. Total scores range from 0 to 46, with higher scores meaning more severe binge eating symptoms (Gormally et al., 1982). | Baseline, 6 weeks, 1 month, and 2 month follow-up |
| Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Kilpela, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78253 | United States |
Per guidelines, we will publish deidentified data results from this trial via ClinicalTrials.gov within one year of study completion. Participants will be informed of this at the time of consent, if they are interested in learning the results from the study.
Within one year of study completion
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| ID | Title | Description |
|---|---|---|
| FG000 | BESTOW Behavioral Intervention | The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. Binge Eating Syndrome Treatment (BESTOW): The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BESTOW Behavioral Intervention | The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. Binge Eating Syndrome Treatment (BESTOW): The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility - Usage Rating Profile - Intervention | Score on the Feasibility Usage Rating Profile. This scale gathers patient reported feasibility of the intervention (e.g., time needed, quality of materials, simplicity of the intervention) to be completed after doing the intervention. This scale has six items; total scores range from 1-6 and a higher scores indicate greater feasibility. | Post-assessment completers | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (post), and 2 month follow-up |
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Baseline to 2-month follow-up
Definitions did not differ from clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BESTOW Behavioral Intervention | The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. Binge Eating Syndrome Treatment (BESTOW): The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Smith Kilpela | UT Health San Antonio | 210-450-8121 | kilpela@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2023 | Oct 28, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2023 | Jul 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study is a beta-testing of a new behavioral intervention treatment - all participants will be assigned to the treatment and give feedback on the treatment throughout the study.
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The CES-D is a 10-item, self-report survey that assess depressive symptoms. Mean scores range from 0 to 3, with higher scores indicating more depressive symptoms (Lewinsohn et al., 1997). |
| Baseline, 6 weeks (post), 1 month, and 2 month follow-up |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Acceptability - Usage Rating Profile - Intervention | Score on the Acceptability Usage Rating Profile scale which gathers participant ratings of how acceptable the treatment is for targeting binge eating (e.g., how helpful the intervention was, how much they liked it, willingness to do the intervention) to be completed after doing the intervention. This scale has eight items; total scores range from 1-6, a higher score indicates greater acceptability. | Post-assessment completers | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (post), and 2 month follow-up |
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| Secondary | Binge Eating Score (BES) | Change in score on the BES survey. The BES is a 16-item, self-report survey that assess binge eating. Total scores range from 0 to 46, with higher scores meaning more severe binge eating symptoms (Gormally et al., 1982). | Completers. One of the subjects was too busy to complete the questionnaire at the 1 month follow up, so only 16 participants were evaluable at that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 1 month, and 2 month follow-up |
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| Secondary | Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | The CES-D is a 10-item, self-report survey that assess depressive symptoms. Mean scores range from 0 to 3, with higher scores indicating more depressive symptoms (Lewinsohn et al., 1997). | Completers. One of the subjects was too busy to complete the questionnaire at the 1 month follow up, so only 16 participants were evaluable at that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks (post), 1 month, and 2 month follow-up |
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