Clinical trial NCT00572520: Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women
Official title: Treating Co-morbid Obesity and Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Obesity
Keywords: Depressive Disorder
Weight Loss
Behavioral Treatment
Behavior Therapy
Randomized Clinical Trial
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-12-13
Enrollment: 161
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in body weight and the trend in body weight over time
timeFrame: Measured at Month 6 and Years 1 and 2
Secondary outcomes:
measure: 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)
timeFrame: Measured at Year 2
measure: Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change
timeFrame: Measured at Year 2
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Sherry L. Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.