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

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).
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- Accelerometer-Derived Activity [ Time Frame: 6 months post-surgery ]accelerometer-derived activity will be collected.
- 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
- Upper Body Strength testing [ Time Frame: baseline, 6 months and 5 years post-surgery ]hand grip and chest press
- Baecke Habitual Physical Activity Questionnaire [ Time Frame: 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 [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
- 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
- St.Vincent Exercise Questionnaire [ Time Frame: baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
- Exercise Identity Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
- NEO-IPIP Conscientiousness Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
- Thoughts of Exercise Scale [ Time Frame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery ]
- Accelerometer-Derived Activity [ Time Frame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery ]
- 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

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

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
United States, Indiana | |
St. Vincent Carmel Hospital Bariatric Center of Excellence | |
Carmel, Indiana, United States, 46032 |
Principal Investigator: | David B Creel, PhD | St. Vincent Carmel Hospital Bariatric Center of Excellence |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |