DepressionNCT00572520
Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
A study testing Weight loss treatment, Behavior therapy for depression and Health education counseling in people with Depression and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Depression, Obesity
- What is being tested?
- Weight loss treatment, Behavior therapy for depression and Health education counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Apr 2012
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for major depressive disorder
- Score of 12 to 24 on Hamilton Depression Rating Scale (HDRS)
- Body mass index (BMI) of 30 to 40 kg
Who cannot join
- Plans to move out of the area during the study
- Current smoker
- Diagnosis of bipolar disorder, a psychotic disorder, bulimia, or post-traumatic stress disorder
- Meets criteria for severe depression (HDRS score greater than 24)
- Diagnosis of type 1 or 2 diabetes
- Plans to have bariatric surgery during the study
Show all 17Show fewer
- No access to a telephone
- Unable to walk unaided or unable to walk 1/4 mile without stopping
- Does not have written clearance from primary care physician for physical activity
- Presence of a condition that precludes dietary changes (e.g., ulcerative colitis, Crohn's disease, active diverticulitis, renal disease)
- Presence of medical conditions likely to limit lifespan
- Taking prescription weight loss medications
- Initiation of anti-depressant medication within the 3 months prior to study entry
- Taking mood stabilizers, antipsychotic medication, or medications known to affect appetite and/or weight (e.g., corticosteroids)
- Reports active suicidal ideation via SCID interview, a score of 3 on item 24 of the HDRS (active suicidal ideation), or determined to have suicidal potential by clinical staff
- Psychiatric hospitalization in the 12 months prior to study entry
- Currently receiving psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Treating Co-morbid Obesity and Major Depressive Disorder
This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.
Read the detailed description
Obesity is one of the most alarming current health problems in the United States, with 31% percent of the population considered obese. Previous studies have shown that there is a higher incidence of depression in people who are overweight. It is not known whether depression causes obesity or vice versa, but the association may stem from the stigma of obesity or from the appetite and weight gain caused by depressive symptoms. With the increased risk of cardiovascular and other life-threatening diseases from obesity, promotion of healthful habits is important. Providing the motivational skills to adhere to these habits is also crucial, especially in people who are both overweight and depressed. This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.
Participants in this 2-year study will be divided into one of two treatment groups: one group will address weight loss and depression via nutrition, exercise, and health education and the other group will address weight loss and depression via nutrition, exercise, and behavioral counseling. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease. Participants receiving behavioral counseling will learn about depression and links between activity and mood. They will also be asked to keep a diary of moods and activities. Participants in both treatment groups will undergo the same schedule of study visits and assessments. A baseline visit will include blood tests; measurements of height, weight, waist size, and blood pressure; and completion of questionnaires about depression, eating habits, and physical activity. Next, over a 3-week period, participants will receive three phone calls asking about food intake from the previous day. In the first 6 months of the study, there will be a total of 26 weekly treatment visits. These visits will consist of ten 1-hour sessions with a counselor and sixteen 90-minute sessions with a dietician. During the next 6 months, participants will continue to meet with their dieticians monthly for a total of 6 visits and will receive monthly phone calls from their counselor. Quaterly phone calls with their counselor will continue in the second year of the study. There will be three check-in appointments similar to the baseline assessment, occurring at Month 6 and Years 1 and 2.
- Conditions
- Depression, Obesity
- Being tested
- Weight loss treatment, Behavior therapy for depression, Health education counseling
- Keywords
- Depressive Disorder, Weight Loss, Behavioral Treatment, Behavior Therapy, Randomized Clinical Trial
- Medical subject headings
- Depression, Obesity, Depressive Disorder, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss treatmentBehavioural
Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor. Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.
Behavior therapy for depressionBehavioural
Behavior therapy for depression will be delivered by a trained behavior therapist. Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities.
Health education counselingBehavioural
Health education counseling will be delivered by a trained health education counselor. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Evidence-based behavioral weight loss treatment with health education counseling Receives: Behavioral: Weight loss treatment; Behavioral: Health education counseling |
| 2 | Experimental | Evidence-based behavioral weight loss treatment with brief behavior therapy for depression Receives: Behavioral: Weight loss treatment; Behavioral: Behavior therapy for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and the trend in body weight over time
Measured: Measured at Month 6 and Years 1 and 2
Secondary outcomes (2)
Change in depression, physical activity, diet (daily caloric intake), psychosocial variables (anhedonia, exercise self-efficacy, disinhibited eating, quality of life), and cardiovascular risk factors (blood pressure, serum lipids, C-reactive protein)
Measured: Measured at Year 2
Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change
Measured: Measured at Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2012
- Study completionApr 2012
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 DepressionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sherry L. Pagoto, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572520
- Sponsor's protocol ID
- R01MH078012
- Other IDs
- R01MH078012, DAHBR 96-BHB
- Status last verified
- Jul 2018
- First submitted
- 11 Dec 2007
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schneider KL, Bodenlos JS, Ma Y, Olendzki B, Oleski J, Merriam P, Crawford S, Ockene IS, Pagoto SL. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder. BMC Psychiatry. 2008 Sep 15;8:77. doi: 10.1186/1471-244X-8-77.
PubMed 18793398
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Co-morbid Obesity and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00572520
- Acronym / sponsor ID
- R01MH078012
- Conditions
- Depression, Obesity
- Keywords
- Depressive Disorder, Weight Loss, Behavioral Treatment, Behavior Therapy, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Dec 2007 (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.
This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.
Detailed description
Obesity is one of the most alarming current health problems in the United States, with 31% percent of the population considered obese. Previous studies have shown that there is a higher incidence of depression in people who are overweight. It is not known whether depression causes obesity or vice versa, but the association may stem from the stigma of obesity or from the appetite and weight gain caused by depressive symptoms. With the increased risk of cardiovascular and other life-threatening diseases from obesity, promotion of healthful habits is important. Providing the motivational skills to adhere to these habits is also crucial, especially in people who are both overweight and depressed. This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.
Participants in this 2-year study will be divided into one of two treatment groups: one group will address weight loss and depression via nutrition, exercise, and health education and the other group will address weight loss and depression via nutrition, exercise, and behavioral counseling. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease. Participants receiving behavioral counseling will learn about depression and links between activity and mood. They will also be asked to keep a diary of moods and activities. Participants in both treatment groups will undergo the same schedule of study visits and assessments. A baseline visit will include blood tests; measurements of height, weight, waist size, and blood pressure; and completion of questionnaires about depression, eating habits, and physical activity. Next, over a 3-week period, participants will receive three phone calls asking about food intake from the previous day. In the first 6 months of the study, there will be a total of 26 weekly treatment visits. These visits will consist of ten 1-hour sessions with a counselor and sixteen 90-minute sessions with a dietician. During the next 6 months, participants will continue to meet with their dieticians monthly for a total of 6 visits and will receive monthly phone calls from their counselor. Quaterly phone calls with their counselor will continue in the second year of the study. There will be three check-in appointments similar to the baseline assessment, occurring at Month 6 and Years 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Weight loss treatment, Behavioral: Health education counselingEvidence-based behavioral weight loss treatment with health education counseling |
| 2 | Experimental | Behavioral: Weight loss treatment, Behavioral: Behavior therapy for depressionEvidence-based behavioral weight loss treatment with brief behavior therapy for depression |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for major depressive disorder
- Score of 12 to 24 on Hamilton Depression Rating Scale (HDRS)
- Body mass index (BMI) of 30 to 40 kg
Key exclusion criteria (17 listed)
- Plans to move out of the area during the study
- Current smoker
- Diagnosis of bipolar disorder, a psychotic disorder, bulimia, or post-traumatic stress disorder
- Meets criteria for severe depression (HDRS score greater than 24)
- Diagnosis of type 1 or 2 diabetes
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 |
|---|---|---|
| Weight loss treatmentOver 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor. Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity. | Behavioural | 1, 2 |
| Behavior therapy for depressionBehavior therapy for depression will be delivered by a trained behavior therapist. Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities. | Behavioural | 2 |
| Health education counselingHealth education counseling will be delivered by a trained health education counselor. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease. | Behavioural | 1 |
Primary outcome
Change in body weight and the trend in body weight over time
Time frame: Measured at Month 6 and Years 1 and 2
2 secondary outcomes
Change in depression, physical activity, diet (daily caloric intake), psychosocial variables (anhedonia, exercise self-efficacy, disinhibited eating, quality of life), and cardiovascular risk factors (blood pressure, serum lipids, C-reactive protein)
Time frame: Measured at Year 2
Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change
Time frame: Measured at Year 2
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 5 Jul 2018.
- Derived from this study: PubMed 18793398Schneider KL, Bodenlos JS, Ma Y, Olendzki B, Oleski J, Merriam P, Crawford S, Ockene IS, Pagoto SL. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder. BMC Psychiatry. 2008 Sep 15;8:77. doi: 10.1186/1471-244X-8-77.
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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.
Sherry L. Pagoto, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss treatment, Behavior therapy for depression and Health education counseling in people with Depression and Obesity, run by University of Massachusetts, Worcester 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 3 inclusion and 17 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 5 Jul 2018. 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?
Change in body weight and the trend in body weight over time (time frame: Measured at Month 6 and Years 1 and 2). 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 NCT00572520, 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 5 Jul 2018.