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Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
This study is currently recruiting participants.
Study NCT00572520   Information provided by National Institute of Mental Health (NIMH)
First Received: December 11, 2007   Last Updated: March 12, 2009   History of Changes

December 11, 2007
March 12, 2009
July 2007
April 2012   (final data collection date for primary outcome measure)
Change in body weight and the trend in body weight over time [ Time Frame: Measured at Month 6 and Years 1 and 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572520 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Same as current
 
Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
Treating Co-Morbid Obesity and Major Depressive Disorder

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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Depression
  • Obesity
  • Behavioral: Weight loss treatment
  • Behavioral: Behavior therapy for depression
  • Behavioral: Health education counseling
  • Active Comparator: Evidence-based behavioral weight loss treatment with health education counseling
  • Experimental: Evidence-based behavioral weight loss treatment with brief behavior therapy for depression
Schneider KL, Bodenlos JS, Ma Y, Olendzki B, Oleski J, Merriam P, Crawford S, Ockene IS, Pagoto SL. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder. BMC Psychiatry. 2008 Sep 15;8:77.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
174
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
21 Years to 65 Years
No
Contact: Jessica Oleski, MA 508-856-1579 jessica.oleski@umassmed.edu
United States
 
NCT00572520
Sherry L. Pagoto, PhD, University of Massachusetts Medical School
R01 MH078012, DAHBR 96-BHB
National Institute of Mental Health (NIMH)
 
Principal Investigator: Sherry L. Pagoto, PhD University of Massachusetts Medical School
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP