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| Name | Class |
|---|---|
| St. Vincent Foundation | OTHER |
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The purpose of the study is to address 3 main sets of questions in the bariatric surgery population. 1) Does bariatric surgery, without any other intervention, lead to increased physical activity and improved physical fitness? 2) Does wearing a pedometer lead to increased physical activity in obese individuals prior to and/or after bariatric surgery? Does the increased activity result in improvements in physical fitness? 3) Does physical activity counseling increase physical activity prior to and or/after bariatric surgery? Does the increased activity result in improvements in physical fitness? The overall goal of the study is to determine the impact of bariatric surgery on physical activity and assess the utility of additional interventions to help postoperative patients adopt a more active lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus exercise counseling before and for the first 6 months after bariatric surgery. In an extension of the primary study, from 1 to 5 years after surgery, all patients receive exercise counseling. Physiological measures will be assessed to determine whether bariatric surgery and/or improved physical activity levels result in improved physical fitness.
Bariatric surgery leads to improvement or resolution of a variety of health conditions. It is also well established that physical activity, with or without weight loss, improves many health-related problems and can have a positive impact on mood. Therefore, physical activity may amplify the health and psychological benefits often experienced from bariatric surgery. Prior to surgery many patients are relatively inactive due to physical and social barriers associated with their weight. In addition, many patients find it difficult to adopt an active lifestyle after surgery, despite an increased capacity to exercise. However, weight loss is associated with physical activity after bariatric surgery. Nonetheless, little is known about the most effective means to promote activity among this group of individuals. This study will examine changes in physical activity and fitness after bariatric surgery and examine whether the addition of pedometer use and exercise counseling may lead to greater improvements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedometer + Exercise Counseling | Experimental |
| |
| Pedometer | Experimental |
| |
| Usual Care | No Intervention | Self-help information provided on physical activity (WIN:Weight Control Network "Active At Any Size" provided by National Institute of Diabetes and Digestive and Kidney Diseases, 2006). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer | Behavioral | Participants are provided with Omron Model HJ-151 pedometers and given instruction on how to use the pedometer to set goals for increasing physical activity. They are given diaries to track their daily step counts. |
| Measure | Description | Time Frame |
|---|---|---|
| Accelerometer-Derived Activity | accelerometer-derived activity will be collected. | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Graded Treadmill Test | length of time participant walks on treadmill until reaching percieved exertion or heart rate target | baseline, 6 months and 5 years post-surgery |
| Upper Body Strength testing |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | weight, blood pressure, pulse, respiratory rate | baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B Creel, PhD | St. Vincent Carmel Hospital Bariatric Center of Excellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Carmel Hospital Bariatric Center of Excellence | Carmel | Indiana | 46032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27367821 | Result | Creel DB, Schuh LM, Reed CA, Gomez AR, Hurst LA, Stote J, Cacucci BM. A randomized trial comparing two interventions to increase physical activity among patients undergoing bariatric surgery. Obesity (Silver Spring). 2016 Aug;24(8):1660-8. doi: 10.1002/oby.21548. Epub 2016 Jul 1. | |
| 28682736 | Derived | Creel DB, Schuh LM, Newton RL Jr, Stote JJ, Cacucci BM. Exercise Testing Reveals Everyday Physical Challenges of Bariatric Surgery Candidates. J Phys Act Health. 2017 Dec 1;14(12):913-918. doi: 10.1123/jpah.2017-0128. Epub 2017 Oct 12. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Exercise Counseling | Behavioral | Manualized cognitive behavioral treatment program including goal setting, adding exercise throughout the day, physical limitations/injuries, maintaining motivation, benefits of exercise, FITT principles, exercise as recreation, and restructuring thoughts related to activity. |
|
hand grip and chest press
| baseline, 6 months and 5 years post-surgery |
| Baecke Habitual Physical Activity Questionnaire | baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
| Myers-Roth Benefits and Barriers of Exercise Questionnaire | baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
| PHQ-9 Symptom Checklist | measure of depressed mood | baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
| St.Vincent Exercise Questionnaire | baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
| Exercise Identity Scale | 12 and 18 months, and 2, 3, 4, and 5 years post-surgery |
| NEO-IPIP Conscientiousness Scale | 12 and 18 months, and 2, 3, 4, and 5 years post-surgery |
| Thoughts of Exercise Scale | 12 and 18 months, and 2, 3, 4, and 5 years post-surgery |
| Accelerometer-Derived Activity | baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |