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Promoting Physical Activity Among Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT01722357
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
St. Vincent Foundation
Information provided by (Responsible Party):
St. Vincent Carmel Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Pedometer Behavioral: Exercise Counseling Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Physical Activity Among Bariatric Surgery Patients
Actual Study Start Date : November 2009
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pedometer + Exercise Counseling Behavioral: Pedometer
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.

Behavioral: Exercise Counseling
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.
Experimental: Pedometer Behavioral: Pedometer
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.
No Intervention: Usual Care
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).


Outcome Measures
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Primary Outcome Measures :
  1. Accelerometer-Derived Activity [ Time Frame: 6 months post-surgery ]
    accelerometer-derived activity will be collected.


Secondary Outcome Measures :
  1. Graded Treadmill Test [ Time Frame: baseline, 6 months and 5 years post-surgery ]
    length of time participant walks on treadmill until reaching percieved exertion or heart rate target

  2. Upper Body Strength testing [ Time Frame: baseline, 6 months and 5 years post-surgery ]
    hand grip and chest press

  3. Baecke Habitual Physical Activity Questionnaire [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
  4. Myers-Roth Benefits and Barriers of Exercise Questionnaire [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
  5. PHQ-9 Symptom Checklist [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
    measure of depressed mood

  6. St.Vincent Exercise Questionnaire [ Time Frame: baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
  7. Exercise Identity Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
  8. NEO-IPIP Conscientiousness Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
  9. Thoughts of Exercise Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
  10. Accelerometer-Derived Activity [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]

Other Outcome Measures:
  1. Vital signs [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
    weight, blood pressure, pulse, respiratory rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722357


Locations
United States, Indiana
St. Vincent Carmel Hospital Bariatric Center of Excellence
Carmel, Indiana, United States, 46032
Sponsors and Collaborators
St. Vincent Carmel Hospital
St. Vincent Foundation
Investigators
Principal Investigator: David B Creel, PhD St. Vincent Carmel Hospital Bariatric Center of Excellence
More Information
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Publications of Results:

Responsible Party: St. Vincent Carmel Hospital
ClinicalTrials.gov Identifier: NCT01722357     History of Changes
Other Study ID Numbers: 09110
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by St. Vincent Carmel Hospital:
bariatric surgery
physical activity
morbid obesity