Binge Eating Syndrome Treatment for Older Women (BESTOW)

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT05806788
Collaborator
National Institute on Aging (NIA) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Binge Eating Syndrome Treatment (BESTOW)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Binge Eating Syndrome Treatment for Older Women (BESTOW)
Actual Study Start Date :
Feb 17, 2023
Anticipated Primary Completion Date :
Feb 17, 2024
Anticipated Study Completion Date :
Feb 17, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility - Usage Rating Profile - Intervention [Baseline to 16 weeks, 1 month, and 2 month follow-up]

    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.

  2. Acceptability - Usage Rating Profile - Intervention [Baseline to 16 weeks, 1 month, and 2 month follow-up]

    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

  1. Binge Eating Score (BES) [Baseline to 16 weeks, 1 month, and 2 month follow-up]

    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).

  2. Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) [Baseline to 16 weeks, 1 month, and 2 month follow-up]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at San Antonio San Antonio Texas United States 78253

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Lisa Kilpela, PhD, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT05806788
Other Study ID Numbers:
  • HSC20220898H
  • 5K76AG060003
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Texas Health Science Center at San Antonio
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023