Clinical trial NCT05806788: Binge Eating Syndrome Treatment for Older Women (BESTOW)
Official title: Binge Eating Syndrome Treatment for Older Women (BESTOW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating
Keywords: Binge Eating Spectrum
Cognitive-behavioral therapy
Body Image
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-04-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility - Usage Rating Profile - Intervention
timeFrame: 6 weeks (post), and 2 month follow-up
measure: Acceptability - Usage Rating Profile - Intervention
timeFrame: 6 weeks (post), and 2 month follow-up
Secondary outcomes:
measure: Binge Eating Score (BES)
timeFrame: Baseline, 6 weeks, 1 month, and 2 month follow-up
measure: Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D)
timeFrame: Baseline, 6 weeks (post), 1 month, and 2 month follow-up
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Lisa Kilpela, PhD
role: PRINCIPAL_INVESTIGATOR
References: