Epidemiology and Care of Comorbid Obesity and Depression



Status:Completed
Conditions:Depression, Depression, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:40 - 65
Updated:10/15/2017
Start Date:April 2004
End Date:April 2007

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials