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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00572520 |
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.
Condition | Intervention | Phase |
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Depression Obesity |
Behavioral: Weight loss treatment Behavioral: Behavior therapy for depression Behavioral: Health education counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treating Co-Morbid Obesity and Major Depressive Disorder |
Estimated Enrollment: | 174 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Evidence-based behavioral weight loss treatment with health education counseling
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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.
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2: Experimental
Evidence-based behavioral weight loss treatment with brief behavior therapy for depression
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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.
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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. Monthly visits with the dietician will continue in the second year of the study and phone calls will continue quarterly. There will be three check-in appointments similar to the baseline assessment, occurring at Month 6 and Years 1 and 2.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica Oleski, MA | 508-856-1579 | jessica.oleski@umassmed.edu |
United States, Massachusetts | |
University of Massachusetts Medical School | Recruiting |
Worcester, Massachusetts, United States, 01655 |
Principal Investigator: | Sherry L. Pagoto, PhD | University of Massachusetts Medical School |
Responsible Party: | University of Massachusetts Medical School ( Sherry L. Pagoto, PhD ) |
Study ID Numbers: | R01 MH078012, DAHBR 96-BHB |
Study First Received: | December 11, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00572520 |
Health Authority: | United States: Federal Government |
Depressive Disorder Weight Loss Behavioral Treatment Behavior Therapy Randomized Clinical Trial |
Obesity Depression Obesity, Morbid Overweight Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Body Weight Signs and Symptoms Mental Disorders Weight Loss Mood Disorders Nutrition Disorders Overnutrition |