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Sponsors and Collaborators: |
University of Pittsburgh East Carolina University |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00692367 |
The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss.
A randomized controlled physical activity intervention trial in a group of patients undergoing bariatric surgery for weight loss. The study will involve two sites with an active bariatric surgery program, which have a strong track record of bariatric surgery research. The study will include 160-200 subjects. Changes in the primary outcome variables will be determined in previous gastric bypass patients as a result of 6 months of moderate physical activity compared to an educational control group not engaged structured exercise.
Condition | Intervention |
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Obesity |
Behavioral: Physical Activity |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Physical Activity Following Surgery Induced Weight Loss |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Disqualifying findings on physical examination include:
If the resting EKG prior to the exercise test shows any abnormalities, the test will not be conducted. If any abnormalities develop during the test, the test will be stopped. On both occasions, the participant will be referred to their PCP for further evaluation and will only be allowed to continue the study with written clearance by his/her PCP or cardiologist. American College of Sports Medicine (ACSM) criteria will be used to halt maximal exercise testing should adverse cardiovascular responses develop. Only after a cardiologist interprets the resting and exercise ECG of the participant and clears them for exercise, will subjects be able to continue with the study
Contact: Krista Clark, MS, RD, LDN | 412-692-2415 | clarkk@dom.pitt.edu |
Contact: Nicole Helbling, MS, RN | 412-692-2285 | rasmussenn@dom.pitt.edu |
United States, North Carolina | |
East Carolina University | Recruiting |
Greenville, North Carolina, United States, 27858 | |
Principal Investigator: Joseph Houmard, PhD | |
United States, Pennsylvania | |
Montefiore Hospital, N807 | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Krista Clark 412-692-2415 clarkk@dom.pitt.edu | |
Contact: Nicole Helbling 412-692-2285 rasmussenn@dom.pitt.edu | |
Principal Investigator: Bret H Goodpaster, PhD |
Principal Investigator: | Bret H Goodpaster, Ph.D. | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Bret H. Goodpaster ) |
Study ID Numbers: | PRO007090041, R01 DK078192-01A1 |
Study First Received: | June 2, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00692367 |
Health Authority: | United States: Institutional Review Board |
Body fat Exercise Fatty acids Impaired glucose tolerance Insulin resistance |
Insulin Sensitivity Metabolic syndrome Obesity Physical activity Weight Loss |
Body Weight Signs and Symptoms Obesity Weight Loss Glucose Intolerance Body Weight Changes |
Nutrition Disorders Overweight Overnutrition Insulin Resistance Insulin |