Promoting Physical Activity Among Bariatric Surgery Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Promoting Physical Activity Among Bariatric Surgery Patients

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Pedometer
* Behavioral: Exercise Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbidly obese patients planning to undergo bariatric surgery at the St. Vincent Bariatric Center of Excellence Men and women 18 years and older The participant must be motivated to enroll in a study assessing physical activity before and after bariatric surgery, able to understand and comply with the study, and must agree to return for scheduled visits All participants must sign a written, informed consent Exclusion Criteria: History of myocardial infarction within the past three months, unstable angina pectoris, sustained or episodic cardiac arrhythmias that could be aggravated by physical activity, symptomatic peripheral vascular disease, or any other medical condition that the medically responsible investigator deems inappropriate. Abnormal electrocardiogram (ECG), assessed at the pretreatment screening visit that the medically responsible investigator deems inappropriate for participation in a physical activity program. Unable to progress toward 30 minutes of continuous walking during the 6 months of study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer + Exercise Counseling<br> | Behavioral: Pedometer<br>* 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.<br>Behavioral: Exercise Counseling<br>* 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.<br>|
| Experimental: Pedometer<br> | Behavioral: Pedometer<br>* 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.<br>|
| No Intervention: Usual Care<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer-Derived Activity | accelerometer-derived activity will be collected. | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, physical activity, morbid obesity