Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169273
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2005-09-12
Brief Title:
Epidemiology and Care of Comorbid Obesity and Depression
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Epidemiology and Care of Comorbid Obesity and Depression
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2
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
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 kgm2
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 300000 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 lossdepression 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
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 lossdepression 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH068127 | NIH | None | httpsreporternihgovquickSearchR01MH068127 |