Binge Eating Syndrome Treatment for Older Women (BESTOW)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility - Usage Rating Profile - Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Significant cognitive impairment
- •Nursing home, long-term care facility
- •Psychosis or imminent suicide risk
- •Current BE treatment
结局指标
主要结局
Feasibility - Usage Rating Profile - Intervention
时间窗: 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.
Acceptability - Usage Rating Profile - Intervention
时间窗: 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.
次要结局
- 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)
研究者
Lisa Kilpela
Associate Professor
The University of Texas Health Science Center at San Antonio