Promoting Physical Activity Among Bariatric Surgery Patients

NCT01722357 | Completed

• 1 other identifier: 09110
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; physical activity; morbid obesity

Outcome Measures

Primary Outcomes (1)

• Accelerometer-Derived Activity

  accelerometer-derived activity will be collected.

  6 months post-surgery

Secondary Outcomes (10)

• Graded Treadmill Test

  baseline, 6 months and 5 years post-surgery

• Upper Body Strength testing

  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

  baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery

Other Outcomes (1)

• Vital signs

  baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery

Study Arms (3)

Pedometer + Exercise Counseling

EXPERIMENTAL

Behavioral: Pedometer; Behavioral: Exercise Counseling

Pedometer

EXPERIMENTAL

Behavioral: Pedometer

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).

Interventions

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.

Pedometer; Pedometer + Exercise Counseling

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.

Pedometer + Exercise Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascension St. Vincent Carmel Hospital: lead
• St. Vincent Foundation: collaborator

Study Sites (1)

St. Vincent Carmel Hospital Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

Location

Related Publications (2)

• 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.

  PMID: 27367821 RESULT

• 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.

  PMID: 28682736 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• David B Creel, PhD

  St. Vincent Carmel Hospital Bariatric Center of Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

US (1)