Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
Condition: Depression; Obesity
MeSH terms: Obesity; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Weight loss treatment; Behavior therapy for depression; Health education counseling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Weight Loss; Behavioral Treatment; Behavior Therapy; Randomized Clinical Trial