ObesityNCT00169273
Epidemiology and Care of Comorbid Obesity and Depression
A study testing Structured behavioral weight loss group and Weight loss and cognitive-behavioral depression group in people with Obesity and Depression, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Obesity, Depression
- What is being tested?
- Structured behavioral weight loss group and Weight loss and cognitive-behavioral depression group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
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
Read more
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.
Read the 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.
- Conditions
- Obesity, Depression
- Being tested
- Structured behavioral weight loss group, Weight loss and cognitive-behavioral depression group
- Keywords
- Obesity, Depression, Behavioral, Cognitive, Treatment
- Medical subject headings
- Obesity, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured behavioral weight loss groupBehavioural
Structured group weight loss program
Weight loss and cognitive-behavioral depression groupBehavioural
Structured group program for weight loss and depression
| Study group | Role | What they receive |
|---|---|---|
| Weight loss only intervention | Active comparator | Structured group weight loss intervention Receives: Behavioral: Structured behavioral weight loss group |
| Combined intervention | Experimental | Structured group program for weight loss and depression Receives: Behavioral: Weight loss and cognitive-behavioral depression group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss since baseline
Measured: 24 months
Mean SCL depression score
Measured: 24 months
Secondary outcomes (3)
Estimated caloric intake
Measured: 24 months
Physical activity
Measured: 24 months
Self-efficacy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Oregon Research Institute
- Responsible party
- Sponsor
- Investigators
- Gregory E Simon, MD MPH, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169273
- Sponsor's protocol ID
- R202009
- Other IDs
- R01MH068127
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2005
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20878292
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Care of Comorbid Obesity and Depression
- ClinicalTrials.gov ID
- NCT00169273
- Acronym / sponsor ID
- R202009
- Conditions
- Obesity, Depression
- Keywords
- Obesity, Depression, Behavioral, Cognitive, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Minnesota, Oregon Research Institute
- Study start
- Apr 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss only intervention | Active comparator | Behavioral: Structured behavioral weight loss groupStructured group weight loss intervention |
| Combined intervention | Experimental | Behavioral: Weight loss and cognitive-behavioral depression groupStructured group program for weight loss and depression |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 to 65
- Body Mass Index >= 30
- Clinically significant depression
- PHQ score of 10 or more
- Current or past major depressive episode
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured behavioral weight loss groupStructured group weight loss program | Behavioural | Weight loss only intervention |
| Weight loss and cognitive-behavioral depression groupStructured group program for weight loss and depression | Behavioural | Combined intervention |
Primary outcome
Weight loss since baseline
Time frame: 24 months
Mean SCL depression score
Time frame: 24 months
3 secondary outcomes
Estimated caloric intake
Time frame: 24 months
Physical activity
Time frame: 24 months
Self-efficacy
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 20878292Linde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory E Simon, MD MPH principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured behavioral weight loss group and Weight loss and cognitive-behavioral depression group in people with Obesity and Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss since baseline (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.