Binge Eating Syndrome Treatment for Older Women (BESTOW)

NCT05806788 | Completed Results DMC

• 2 other identifiers: HSC20220898H5K76AG060003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating

Keywords

Binge Eating Spectrum; Cognitive-behavioral therapy; Body Image

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Binge Eating Score (BES)

  Baseline, 6 weeks, 1 month, and 2 month follow-up

• Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D)

  Baseline, 6 weeks (post), 1 month, and 2 month follow-up

Study Arms (1)

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.

Behavioral: Binge Eating Syndrome Treatment (BESTOW)

Interventions

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.

BESTOW behavioral intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant cognitive impairment
• Nursing home, long-term care facility
• Psychosis or imminent suicide risk
• Current BE treatment

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78253, United States

Location

MeSH Terms

Conditions

Bulimia

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lisa Smith Kilpela
• Organization: UT Health San Antonio

kilpela@uthscsa.edu

210-450-8121

Study Officials

• Lisa Kilpela, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 10, 2023
• Study Start: February 17, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within one year of study completion

Locations

US (1)