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

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.

Study Overview

• Status: Completed
• Conditions: Binge Eating
• Intervention / Treatment: Behavioral: Binge Eating Syndrome Treatment (BESTOW)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78253
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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, 6 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. 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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lisa Kilpela, PhD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive-behavioral therapy; Body Image; Binge Eating Spectrum
• Additional Relevant MeSH Terms: Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Bulimia; Binge-Eating Disorder
• Other Study ID Numbers: HSC20220898H; 5K76AG060003 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No