Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Treating Co-morbid Obesity and Major Depressive Disorder

Conditions
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Depression, Obesity

Intervention / Treatment
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* Behavioral: Weight loss treatment
* Behavioral: Behavior therapy for depression
* Behavioral: Health education counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Evidence-based behavioral weight loss treatment with health education counseling | Behavioral: Weight loss treatment<br>* 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.<br>Behavioral: Health education counseling<br>* 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.<br>|
| Experimental: 2<br>Evidence-based behavioral weight loss treatment with brief behavior therapy for depression | Behavioral: Weight loss treatment<br>* 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.<br>Behavioral: Behavior therapy for depression<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight and the trend in body weight over time |  | Measured at Month 6 and Years 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Measured at Year 2 | 
| Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change |  | Measured at Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Weight Loss, Behavioral Treatment, Behavior Therapy, Randomized Clinical Trial