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Epidemiology and Care of Comorbid Obesity and Depression

NCT00169273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2017-10-13

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Structured behavioral weight loss group

Structured group weight loss program

BEHAVIORAL

Weight loss and cognitive-behavioral depression group

Structured group program for weight loss and depression

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • Oregon Research Institute

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Gregory E Simon, MD MPH · Group Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-02-28
Completion
2007-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00169273 on ClinicalTrials.gov