Epidemiology and Care of Comorbid Obesity and Depression

October 11, 2017 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss since baseline
Time Frame: 24 months
24 months
Mean SCL depression score
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated caloric intake
Time Frame: 24 months
24 months
Physical activity
Time Frame: 24 months
24 months
Self-efficacy
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

University of Minnesota
Oregon Research Institute

Investigators

  • Principal Investigator: Gregory E Simon, MD MPH, Group Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R202009
  • R01MH068127 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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