Physical Activity Clinical Trial
Official title:
Increasing Physical Activity Among Inactive Bariatric Surgery Patients
Verified date | March 2016 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. This study will compare the effects of a behavioral physical activity intervention with a standard care control condition on changes in physical activity among inactive adult bariatric surgery patients.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - BMI equal to or greater than 40 or greater than or equal to 35 (in presence of significant comorbidities) - Have elected to undergo Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding - Able to engage in activities of daily living - Currently inactive, defined as less than 150 weekly minutes of moderate-to-vigorous physical activity in bouts of 10 minutes or more - Obtainment of written consent from surgeon to participate Exclusion Criteria: - Unable to engage in activities of daily living - Report conditions that would render the participant unlikely to follow the study protocol (e.g., relocation, substance abuse, severe psychiatric condition) - Inability to understand program instructions due to language barrier or a mental disability |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Weight Control and Diabetes Research Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total | 6-week Post-intervention follow-up | No | |
Secondary | Change in MVPA, bout-related and total | 3- and 6-month postoperative follow-up | No | |
Secondary | Changes in health-related quality of life | 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up | No | |
Secondary | Changes in physical activity self-efficacy and outcome expectations | Post-intervention follow-up, 3- and 6-month postoperative follow-up | No | |
Secondary | Changes in physical activity enjoyment | Post-intervention, 3- and 6-month postoperative follow-up | No | |
Secondary | Weight | post-intervention follow-up, 3- and 6-months postoperative | No |
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