Epidemiology and Care of Comorbid Obesity and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Weight loss since baseline
研究概览
简要总结
We propose to:
- Conduct cross-sectional assessments of depression, disability, health-related quality of life, eating patterns, and eating attitudes in a population-based sample approximately 6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2.
- Among obese women free of depression, enroll approximately 100 in a 6-month standard behavior therapy weight management program.
- Among obese women with significant depression, randomly assign 200 to either a 6-month standard behavior therapy weight management program or a combined cognitive-behavior therapy program focused on both depression and weight management.
- Complete follow up assessments of weight, depressive symptoms, and functional status in all three treatment groups for 12 months following enrollment
Screening and follow-up data will be used to address the following questions:
- Association between depression and obesity among middle-aged women
- Specific effects of depression and obesity on functional status, disability, and health services utilization
- Impact of depression on participation in and outcomes of a standardized weight management program
- Benefit of combined treatment (focused on depression and weight management) above that of standardized behavioral therapy for obese women with significant depressive symptoms.
详细描述
Obesity is a significant and growing public health concern, accounting for approximately 300,000 excess deaths per year and approximately 9% of US health care expenditures. Prevalence of obesity has steadily increased, with an estimated rate among middle-aged women exceeding 30%. Obesity has a substantial impact on medical morbidity and health-related quality of life.
Public health approaches to the prevention and treatment of obesity must consider the substantial overlap with depression. Some data suggest a 50% increase in risk of depression among obese women. Women with a history of depression or depression treatment are over-represented among those seeking obesity treatment. Current or past depression is also associated with less success in losing weight or maintaining weight loss. Because women with depressive disorders are typically excluded from clinical trials of weight loss treatments, data on the management of comorbid depression and obesity are limited.
We propose two related studies: A population-based epidemiologic study of the association between obesity and depression among women and a longitudinal study of obesity treatment among two cohorts (one with comorbid obesity and depression, one with obesity only) identified by the epidemiologic study.
Study 1 - Epidemiologic Study: A population-based sample of approximately 6000 women aged 40-65 will complete structured telephone assessment of weight, nutrient intake, physical activity, depression, functional impairment, and disability. Women with Body Mass Index (BMI) >30 will be oversampled. Insurance claims data will be used to measure health care costs. Aims of the epidemiologic study include:
- Examine the association between obesity and depression among middle-aged women. Secondary analyses will examine possible mechanisms for any association.
- Examine the specific contributions of obesity and depression to disability, functional impairment, and health care utilization and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 65
- •Body Mass Index >= 30
- •Clinically significant depression
- •PHQ score of 10 or more
- •Current or past major depressive episode
- •Current symptoms include depressed mood or loss of interest
- •Enrolled in Group Health Cooperative health plan
排除标准
- •History of treatment for bipolar disorder or schizophrenia
- •Not willing to participate in group intervention
- •Medical contra-indications to graded exercise program
- •Unable to walk for 10 minutes
研究组 & 干预措施
Weight loss only intervention
Structured group weight loss intervention
干预措施: Structured behavioral weight loss group (Behavioral)
Combined intervention
Structured group program for weight loss and depression
干预措施: Weight loss and cognitive-behavioral depression group (Behavioral)
结局指标
主要结局
Weight loss since baseline
时间窗: 24 months
Mean SCL depression score
时间窗: 24 months
次要结局
- Estimated caloric intake(24 months)
- Physical activity(24 months)
- Self-efficacy(24 months)