Binge Eating Syndrome Treatment for Older Women (BESTOW)

Binge Eating Clinical Trial

— BESTOW  

Official title:

Binge Eating Syndrome Treatment for Older Women (BESTOW)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806788
• Other study ID #: HSC20220898H
• Secondary ID: 5K76AG060003
• Status: Completed
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: November 14, 2023

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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