Epidemiology and Care of Comorbid Obesity and Depression
Condition: Obesity; Depression
MeSH terms: Obesity; Depression; Depressive Disorder
Study type: Interventional

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:

        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.
    

Intervention name(s): Structured behavioral weight loss group; Weight loss and cognitive-behavioral depression group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Structured group weight loss program; Structured group program for weight loss and depression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Depression; Behavioral; Cognitive; Treatment