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Completed

NCT Number: NCT01722357

Promoting Physical Activity Among Bariatric Surgery Patients

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent Carmel Hospital Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Accelerometer-Derived Activity

    Time frame: 6 months post-surgery

    accelerometer-derived activity will be collected.

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ascension St. Vincent Carmel Hospital

Other

Collaborators

  • St. Vincent Foundation

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2019
First posted
Nov 6, 2012
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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