Physical Fitness and Nutrition Intake in Bariatric Surgery Population

Completed

• Conditions: Obesity

• Registration Number: NCT02070354
• Lead Sponsor: Geisinger Clinic

Brief Summary

The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.

This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.

Detailed Description

This is a two-pronged study. The first phase is a cross-sectional study design meaning each participant will only be tested once. The investigators wish to test patients from each of the groups listed below to determine CR fitness, activity level, and nutrient intake. The investigators wish to determine if any improvements from bariatric surgery can be maintained over a 2-year period following surgery. If this is the case, our next project will be to track the patients recruited at their new visit longitudinally at all of the five time points listed below.

1. New visit with GI Nutrition

2. 1 month prior to bariatric surgery (at the time of the patient's initial visit with the surgeon (6-7 months after their new visit))

3. 6 months after bariatric surgery

4. 12 months after bariatric surgery

5. 24 months after bariatric surgery

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Primary Completion: 2014-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA.
• Ability to perform a 6 Minute Walk Test.
• Aged 18 through 70.
• Willingness to receive dietary recall phone calls and accessibility to a telephone.

Exclusion Criteria

• Patients with severe lung disease requiring oxygen therapy.
• Pulmonary embolus or pulmonary infarction.
• Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent).
• Unstable angina.
• Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise.
• Patients with any health reason that limits walking.
• Patients with a temporary injury that limits walking.
• Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living.
• Patients predetermined to be illiterate or incompetent.
• Patients who are currently pregnant or have been pregnant at any time since bariatric surgery.
• Tobacco use.
• Patients with electronic defibrillators or other embedded electronic medical devices.
• Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
• Patients who have undergone revisional bariatric surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Month Post-Operative 6 Min Walk Test	1 Month Post-Operative	6 Min Walk for Distance
6 Month Post-Operative 6 Min Walk Test	6 Month Post-Operative	6 Min Walk for Distance
12 Month Post-Operative 6 Min Walk Test	12 Month Post-Operative	6 Min Walk for Distance
24 Month Post-Operative 6 Min Walk Test	24 Month Post-Operative	6 Min Walk for Distance
Peak Oxygen Uptake (peak VO2)	36 Month Post-Operative	Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.
Pre-Operative 6 Min Walk Test	Pre-operative	6 Min Walk for Distance

Secondary Outcome Measures

Name	Time	Method
Pre-operatively Physical activity	Pre-operatively	Measured using 7 days of accelerometry (actigraph).
1 Month Post-Operative Physical activity	1 Month Post-Operative	Measured using 7 days of accelerometry (actigraph).
6 Month Post-Operative Physical activity	6 Month Post-Operative	Measured using 7 days of accelerometry (actigraph).
12 Month Post-Operative Physical activity	12 Month Post-Operative	Measured using 7 days of accelerometry (actigraph).
24 Month Post-Operative Physical activity	24 Month Post-Operative	Measured using 7 days of accelerometry (actigraph).
36 Month Post-Operative Physical activity	36 Month Post-Operative	Measured using 7 days of accelerometry (actigraph).

Trial Locations

Locations (1)

Geisinger Clinic; 🇺🇸 Danville, Pennsylvania, United States