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Epidemiology and Care of Comorbid Obesity and Depression

Primary Purpose

Obesity, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured behavioral weight loss group
Weight loss and cognitive-behavioral depression group
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Depression, Behavioral, Cognitive, Treatment

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight loss only intervention

Combined intervention

Arm Description

Structured group weight loss intervention

Structured group program for weight loss and depression

Outcomes

Primary Outcome Measures

Weight loss since baseline
Mean SCL depression score

Secondary Outcome Measures

Estimated caloric intake
Physical activity
Self-efficacy

Full Information

First Posted
September 12, 2005
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
University of Minnesota, Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00169273
Brief Title
Epidemiology and Care of Comorbid Obesity and Depression
Official Title
Epidemiology and Care of Comorbid Obesity and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of Minnesota, Oregon Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Examine the association between obesity and depression among middle-aged women. Secondary analyses will examine possible mechanisms for any association. 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Depression
Keywords
Obesity, Depression, Behavioral, Cognitive, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight loss only intervention
Arm Type
Active Comparator
Arm Description
Structured group weight loss intervention
Arm Title
Combined intervention
Arm Type
Experimental
Arm Description
Structured group program for weight loss and depression
Intervention Type
Behavioral
Intervention Name(s)
Structured behavioral weight loss group
Intervention Description
Structured group weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Weight loss and cognitive-behavioral depression group
Intervention Description
Structured group program for weight loss and depression
Primary Outcome Measure Information:
Title
Weight loss since baseline
Time Frame
24 months
Title
Mean SCL depression score
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Estimated caloric intake
Time Frame
24 months
Title
Physical activity
Time Frame
24 months
Title
Self-efficacy
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory E Simon, MD MPH
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20878292
Citation
Linde JA, Simon GE, Ludman EJ, Ichikawa LE, Operskalski BH, Arterburn D, Rohde P, Finch EA, Jeffery RW. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression. Ann Behav Med. 2011 Feb;41(1):119-30. doi: 10.1007/s12160-010-9232-2.
Results Reference
derived

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Epidemiology and Care of Comorbid Obesity and Depression

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