Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
Treating Co-morbid Obesity and Major Depressive Disorder
研究概览
地位
详细说明
Obesity is one of the most alarming current health problems in the United States, with 31% percent of the population considered obese. Previous studies have shown that there is a higher incidence of depression in people who are overweight. It is not known whether depression causes obesity or vice versa, but the association may stem from the stigma of obesity or from the appetite and weight gain caused by depressive symptoms. With the increased risk of cardiovascular and other life-threatening diseases from obesity, promotion of healthful habits is important. Providing the motivational skills to adhere to these habits is also crucial, especially in people who are both overweight and depressed. This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.
Participants in this 2-year study will be divided into one of two treatment groups: one group will address weight loss and depression via nutrition, exercise, and health education and the other group will address weight loss and depression via nutrition, exercise, and behavioral counseling. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease. Participants receiving behavioral counseling will learn about depression and links between activity and mood. They will also be asked to keep a diary of moods and activities. Participants in both treatment groups will undergo the same schedule of study visits and assessments. A baseline visit will include blood tests; measurements of height, weight, waist size, and blood pressure; and completion of questionnaires about depression, eating habits, and physical activity. Next, over a 3-week period, participants will receive three phone calls asking about food intake from the previous day. In the first 6 months of the study, there will be a total of 26 weekly treatment visits. These visits will consist of ten 1-hour sessions with a counselor and sixteen 90-minute sessions with a dietician. During the next 6 months, participants will continue to meet with their dieticians monthly for a total of 6 visits and will receive monthly phone calls from their counselor. Quaterly phone calls with their counselor will continue in the second year of the study. There will be three check-in appointments similar to the baseline assessment, occurring at Month 6 and Years 1 and 2.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Medical School
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Meets DSM-IV criteria for major depressive disorder
- Score of 12 to 24 on Hamilton Depression Rating Scale (HDRS)
- Body mass index (BMI) of 30 to 40 kg
Exclusion Criteria:
- Plans to move out of the area during the study
- Current smoker
- Diagnosis of bipolar disorder, a psychotic disorder, bulimia, or post-traumatic stress disorder
- Meets criteria for severe depression (HDRS score greater than 24)
- Diagnosis of type 1 or 2 diabetes
- Plans to have bariatric surgery during the study
- No access to a telephone
- Unable to walk unaided or unable to walk 1/4 mile without stopping
- Does not have written clearance from primary care physician for physical activity
- Presence of a condition that precludes dietary changes (e.g., ulcerative colitis, Crohn's disease, active diverticulitis, renal disease)
- Presence of medical conditions likely to limit lifespan
- Taking prescription weight loss medications
- Initiation of anti-depressant medication within the 3 months prior to study entry
- Taking mood stabilizers, antipsychotic medication, or medications known to affect appetite and/or weight (e.g., corticosteroids)
- Reports active suicidal ideation via SCID interview, a score of 3 on item 24 of the HDRS (active suicidal ideation), or determined to have suicidal potential by clinical staff
- Psychiatric hospitalization in the 12 months prior to study entry
- Currently receiving psychotherapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:1
Evidence-based behavioral weight loss treatment with health education counseling
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Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor.
Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.
Health education counseling will be delivered by a trained health education counselor.
Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease.
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实验性的:2
Evidence-based behavioral weight loss treatment with brief behavior therapy for depression
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Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor.
Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.
Behavior therapy for depression will be delivered by a trained behavior therapist.
Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in body weight and the trend in body weight over time
大体时间:Measured at Month 6 and Years 1 and 2
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Measured at Month 6 and Years 1 and 2
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次要结果测量
结果测量 |
大体时间 |
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Change in depression, physical activity, diet (daily caloric intake), psychosocial variables (anhedonia, exercise self-efficacy, disinhibited eating, quality of life), and cardiovascular risk factors (blood pressure, serum lipids, C-reactive protein)
大体时间:Measured at Year 2
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Measured at Year 2
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Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change
大体时间:Measured at Year 2
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Measured at Year 2
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合作者和调查者
调查人员
- 首席研究员:Sherry L. Pagoto, PhD、University of Massachusetts, Worcester
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Weight loss treatment的临床试验
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The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)尚未招聘
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中