Obesity Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
| Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
| Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
| Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
| Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
| Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
| Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
| Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
| Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
| Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
| Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
| Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
| Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
| Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
| Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |