Promoting Physical Activity Among Bariatric Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by St. Vincent Carmel Hospital
Sponsor:
Collaborator:
St. Vincent Foundation
Information provided by (Responsible Party):
St. Vincent Carmel Hospital
ClinicalTrials.gov Identifier:
NCT01722357
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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. Physiological measures will be assessed to determine whether bariatric surgery and/or improved physical activity levels result in improved physical fitness.


Condition Intervention
Obesity
Behavioral: Pedometer
Behavioral: Exercise Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Physical Activity Among Bariatric Surgery Patients

Resource links provided by NLM:


Further study details as provided by St. Vincent Carmel Hospital:

Primary Outcome Measures:
  • Accelerometer-Derived Activity [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    accelerometer-derived activity will be collected.


Secondary Outcome Measures:
  • Graded Treadmill Test [ Time Frame: baseline and 6 months post-surgery ] [ Designated as safety issue: No ]
    length of time participant walks on treadmill until reaching percieved exertion or heart rate target

  • Upper Body Strength testing [ Time Frame: baseline and 6 months post-surgery ] [ Designated as safety issue: No ]
    hand grip and chest press

  • Baecke Habitual Physical Activity Questionnaire [ Time Frame: baseline, 2, 4, and 6 months post-surgery ] [ Designated as safety issue: No ]
  • Myers-Roth Benefits and Barriers of Exercise Questionnaire [ Time Frame: baseline, 2, 4, and 6 months post-surgery ] [ Designated as safety issue: No ]
  • PHQ-9 Symptom Checklist [ Time Frame: baseline, 2, 4, and 6 months post-surgery ] [ Designated as safety issue: No ]
    measure of depressed mood

  • St.Vincent Exercise Questionnaire [ Time Frame: baseline , 2, 4, and 6 months post-surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Vital signs [ Time Frame: baseline , 2, 4, and 6 months post-surgery ] [ Designated as safety issue: Yes ]
    weight, blood pressure, pulse,respiratory rate


Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722357

Contacts
Contact: Leslie M Schuh, PhD 317-582-8210 lmschuh@stvincent.org
Contact: David B Creel, PhD 317-582-8029 dbcreel@stvincent.org

Locations
United States, Indiana
St. Vincent Carmel Hospital Bariatric Center of Excellence Recruiting
Carmel, Indiana, United States, 46032
Principal Investigator: David B Creel, PhD         
Sub-Investigator: Leslie M Schuh, PhD         
Sub-Investigator: Adrienne Gomez, MD         
Sub-Investigator: Christina Reed, LPN         
Sub-Investigator: Ineke Madderom         
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

No publications provided

Responsible Party: St. Vincent Carmel Hospital
ClinicalTrials.gov Identifier: NCT01722357     History of Changes
Other Study ID Numbers: 09110
Study First Received: November 2, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014