Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
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|ClinicalTrials.gov Identifier: NCT00572520|
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : April 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression Obesity||Behavioral: Weight loss treatment Behavioral: Behavior therapy for depression Behavioral: Health education counseling||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treating Co-morbid Obesity and Major Depressive Disorder|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Active Comparator: 1
Evidence-based behavioral weight loss treatment with health education counseling
Behavioral: Weight loss treatment
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.Behavioral: Health education counseling
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.
Evidence-based behavioral weight loss treatment with brief behavior therapy for depression
Behavioral: Weight loss treatment
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.Behavioral: Behavior therapy for depression
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.
- Change in body weight and the trend in body weight over time [ Time Frame: Measured at Month 6 and Years 1 and 2 ]
- 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) [ Time Frame: Measured at Year 2 ]
- Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change [ Time Frame: Measured at Year 2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572520
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Sherry L. Pagoto, PhD||University of Massachusetts, Worcester|