Epidemiology and Care of Comorbid Obesity and Depression

This study has been completed.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Oregon Research Institute
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00169273
First received: September 12, 2005
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

We propose to:

  • Conduct cross-sectional assessments of depression, disability, health-related quality of life, eating patterns, and eating attitudes in a population-based sample approximately 6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2.
  • Among obese women free of depression, enroll approximately 100 in a 6-month standard behavior therapy weight management program.
  • Among obese women with significant depression, randomly assign 200 to either a 6-month standard behavior therapy weight management program or a combined cognitive-behavior therapy program focused on both depression and weight management.
  • Complete follow up assessments of weight, depressive symptoms, and functional status in all three treatment groups for 12 months following enrollment

Screening and follow-up data will be used to address the following questions:

  • Association between depression and obesity among middle-aged women
  • Specific effects of depression and obesity on functional status, disability, and health services utilization
  • Impact of depression on participation in and outcomes of a standardized weight management program
  • Benefit of combined treatment (focused on depression and weight management) above that of standardized behavioral therapy for obese women with significant depressive symptoms.

Condition Intervention
Obesity
Depression
Behavioral: Structured behavioral weight loss group
Behavioral: Weight loss and cognitive-behavioral depression group

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: Epidemiology and Care of Comorbid Obesity and Depression

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Weight loss since baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean SCL depression score [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated caloric intake [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Weight loss only intervention
Structured group weight loss intervention
Behavioral: Structured behavioral weight loss group
Structured group weight loss program
Experimental: Combined intervention
Structured group program for weight loss and depression
Behavioral: Weight loss and cognitive-behavioral depression group
Structured group program for weight loss and depression

Detailed Description:

Obesity is a significant and growing public health concern, accounting for approximately 300,000 excess deaths per year and approximately 9% of US health care expenditures. Prevalence of obesity has steadily increased, with an estimated rate among middle-aged women exceeding 30%. Obesity has a substantial impact on medical morbidity and health-related quality of life.

Public health approaches to the prevention and treatment of obesity must consider the substantial overlap with depression. Some data suggest a 50% increase in risk of depression among obese women. Women with a history of depression or depression treatment are over-represented among those seeking obesity treatment. Current or past depression is also associated with less success in losing weight or maintaining weight loss. Because women with depressive disorders are typically excluded from clinical trials of weight loss treatments, data on the management of comorbid depression and obesity are limited.

We propose two related studies: A population-based epidemiologic study of the association between obesity and depression among women and a longitudinal study of obesity treatment among two cohorts (one with comorbid obesity and depression, one with obesity only) identified by the epidemiologic study.

Study 1 - Epidemiologic Study: A population-based sample of approximately 6000 women aged 40-65 will complete structured telephone assessment of weight, nutrient intake, physical activity, depression, functional impairment, and disability. Women with Body Mass Index (BMI) >30 will be oversampled. Insurance claims data will be used to measure health care costs. Aims of the epidemiologic study include:

  1. Examine the association between obesity and depression among middle-aged women. Secondary analyses will examine possible mechanisms for any association.
  2. Examine the specific contributions of obesity and depression to disability, functional impairment, and health care utilization and cost.

Study 2 - Treatment study: A cohort of approximately 100 women with obesity (BMI > 30) and no current depressive disorder will be enrolled in a 6-month state-of-the-art group weight loss treatment. Approximately 200 women with comorbid obesity and depression will be randomly assigned to either the identical weight loss treatment or to a combined cognitive-behavior group therapy program focused on both depression and weight loss. Aims of the treatment study will include:

  1. Examine the effect of depression on success in weight loss treatment by comparing weight loss, nutrient intake, and physical activity in depressed and non-depressed women enrolled in the identical weight loss program. Secondary analyses will examine mechanisms for any observed difference.
  2. Examine the benefits of a combined weight loss/depression intervention above those of weight loss treatment alone by comparing weight loss, nutrient intake, physical activity, depressive symptoms, functional impairment, and disability in the two groups of women with comorbid obesity and depression randomly assigned to the two different intervention programs.
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 to 65
  • Body Mass Index >= 30
  • Clinically significant depression
  • PHQ score of 10 or more
  • Current or past major depressive episode
  • Current symptoms include depressed mood or loss of interest
  • Enrolled in Group Health Cooperative health plan

Exclusion Criteria:

  • History of treatment for bipolar disorder or schizophrenia
  • Not willing to participate in group intervention
  • Medical contra-indications to graded exercise program
  • Unable to walk for 10 minutes
  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: NCT00169273

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
University of Minnesota - Clinical and Translational Science Institute
Oregon Research Institute
Investigators
Principal Investigator: Gregory E Simon, MD MPH Group Health Research Institute
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00169273     History of Changes
Other Study ID Numbers: R202009, R01 MH68127
Study First Received: September 12, 2005
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Obesity
Depression
Behavioral
Cognitive
Treatment

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 August 27, 2014