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Completed

NCT Number: NCT05806788

Binge Eating Syndrome Treatment for Older Women (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.

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Key information

Conditions

Binge Eating Bulimia Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78253, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility - Usage Rating Profile - Intervention

    Time frame: 6 weeks (post), and 2 month follow-up

    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.

  2. Acceptability - Usage Rating Profile - Intervention

    Time frame: 6 weeks (post), and 2 month follow-up

    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.

Secondary outcomes

  1. Binge Eating Score (BES)

    Time frame: Baseline, 6 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)

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

    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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: BESTOW

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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