Binge Eating Syndrome Treatment for Older Women (BESTOW)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Binge Eating Syndrome Treatment for Older Women (BESTOW)

Conditions
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Binge Eating

Intervention / Treatment
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* Behavioral: Binge Eating Syndrome Treatment (BESTOW)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Age 60 years and over Binge eating (BE) ≥1/week during the past ≥3 months Community-dwelling Able to provide informed consent Consistent medication regimen for 3 months Exclusion Criteria: Significant cognitive impairment Nursing home, long-term care facility Psychosis or imminent suicide risk Current BE treatment

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BESTOW behavioral intervention<br>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. | Behavioral: Binge Eating Syndrome Treatment (BESTOW)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Usage Rating Profile - Intervention | Change in in 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). This scale has six items; total scores indicate greater feasibility. | Baseline to 16 weeks, 1 month, and 2 month follow-up | 
| Acceptability - Usage Rating Profile - Intervention | Change in 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). This scale has eight items; total scores indicate greater acceptability. | Baseline to 16 weeks, 1 month, and 2 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 to 16 weeks, 1 month, and 2 month follow-up | 
| 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. Total scores range from 0 to 30, with higher scores indicating more depressive symptoms (Lewinsohn et al., 1997). | Baseline to 16 weeks, 1 month, and 2 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image