Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sherry Pagoto, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00572520
First received: December 11, 2007
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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
Depression
Obesity
Behavioral: Weight loss treatment
Behavioral: Behavior therapy for depression
Behavioral: Health education counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Co-morbid Obesity and Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 161
Study Start Date: July 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572520

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Sherry L. Pagoto, PhD University of Massachusetts, Worcester
  More Information

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sherry Pagoto, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00572520     History of Changes
Other Study ID Numbers: R01 MH078012, R01MH078012, DAHBR 96-BHB
Study First Received: December 11, 2007
Last Updated: April 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
Depressive Disorder
Weight Loss
Behavioral Treatment
Behavior Therapy
Randomized Clinical Trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Obesity
Behavioral Symptoms
Mood Disorders
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014