Physical Fitness and Nutrition Intake in Bariatric Surgery Population

Physical Fitness and Macro- and Micro- Nutrient Intake in a Morbidly Obese Bariatric Surgery Population

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.

Study Overview

• Status: Completed
• Conditions: Obesity

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2111
      • Geisinger Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 210 Geisinger subjects will participate in this study. Participants will be volunteers from the patient population of the Center for Nutrition and Weight Management between the ages of 18 and 70 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Group 1; New clinic visit in GI Nutrition (prior to bariatric surgery).
Group 2; 1 month prior to bariatric surgery
Group 3; 6 months after bariatric surgery
Group 4; 12 months after bariatric surgery
Group 5; 24 months after bariatric surgery
Group 6; ≥ 36 months after bariatric surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative Dietary Intake	Measured using three 24 h dietary recalls.	Pre-operatively
1 Month Post-operative Dietary Intake	Measured using three 24 h dietary recalls.	1 Month Post-operative
12 Month Post-operative Dietary Intake	Measured using three 24 h dietary recalls.	12 Month Post-operative
24 Month Post-operative Dietary Intake	Measured using three 24 h dietary recalls.	24 Month Post-operative
Post-operative Dietary Intake	Measured using three 24 h dietary recalls.	36 Month Post-operative

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Christopher D. Still, DO, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Nutrition; Bariatric surgery; Weight Loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2009-0182