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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 : July 4, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE December 13, 2007
Last Update Posted Date July 4, 2018
Study Start Date  ICMJE July 2007
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Change in body weight and the trend in body weight over time [ Time Frame: Measured at Month 6 and Years 1 and 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00572520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
Official Title  ICMJE Treating Co-morbid Obesity and Major Depressive Disorder
Brief 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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms
  • Active Comparator: 1
    Evidence-based behavioral weight loss treatment with health education counseling
    Interventions:
    • Behavioral: Weight loss treatment
    • Behavioral: Health education counseling
  • Experimental: 2
    Evidence-based behavioral weight loss treatment with brief behavior therapy for depression
    Interventions:
    • Behavioral: Weight loss treatment
    • Behavioral: Behavior therapy for depression
Publications * 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. doi: 10.1186/1471-244X-8-77.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2012)
161
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2007)
174
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00572520
Other Study ID Numbers  ICMJE R01MH078012( U.S. NIH Grant/Contract )
R01MH078012 ( U.S. NIH Grant/Contract )
DAHBR 96-BHB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Sherry L. Pagoto, PhD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date July 2018

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