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

Primary Purpose

Binge Eating

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Binge Eating Syndrome Treatment (BESTOW)
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BESTOW behavioral intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
March 22, 2023
Last Updated
July 31, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05806788
Brief Title
Binge Eating Syndrome Treatment for Older Women (BESTOW)
Acronym
BESTOW
Official Title
Binge Eating Syndrome Treatment for Older Women (BESTOW)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating
Keywords
Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BESTOW behavioral intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Binge Eating Syndrome Treatment (BESTOW)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - Usage Rating Profile - Intervention
Description
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.
Time Frame
Baseline to 16 weeks, 1 month, and 2 month follow-up
Title
Acceptability - Usage Rating Profile - Intervention
Description
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.
Time Frame
Baseline to 16 weeks, 1 month, and 2 month follow-up
Secondary Outcome Measure Information:
Title
Binge Eating Score (BES)
Description
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).
Time Frame
Baseline to 16 weeks, 1 month, and 2 month follow-up
Title
Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D)
Description
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).
Time Frame
Baseline to 16 weeks, 1 month, and 2 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Kilpela, PhD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78253
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Within one year of study completion

Learn more about this trial

Binge Eating Syndrome Treatment for Older Women (BESTOW)

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