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Physical Fitness and Nutrition Intake in Bariatric Surgery Population

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02070354
Enrollment
73
Registered
2014-02-25
Start date
2009-08-31
Completion date
Unknown
Last updated
2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Bariatric surgery, Physical Activity, Nutrition, Weight Loss

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

Interventions

None listed

Sponsors

Geisinger Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
24 Month Post-Operative 6 Min Walk Test24 Month Post-Operative6 Min Walk for Distance
12 Month Post-Operative 6 Min Walk Test12 Month Post-Operative6 Min Walk for Distance
1 Month Post-Operative 6 Min Walk Test1 Month Post-Operative6 Min Walk for Distance
6 Month Post-Operative 6 Min Walk Test6 Month Post-Operative6 Min Walk for Distance
Peak Oxygen Uptake (peak VO2)36 Month Post-OperativeMeasured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.
Pre-Operative 6 Min Walk TestPre-operative6 Min Walk for Distance

Secondary

MeasureTime frameDescription
12 Month Post-Operative Physical activity12 Month Post-OperativeMeasured using 7 days of accelerometry (actigraph).
Pre-operatively Physical activityPre-operativelyMeasured using 7 days of accelerometry (actigraph).
1 Month Post-Operative Physical activity1 Month Post-OperativeMeasured using 7 days of accelerometry (actigraph).
6 Month Post-Operative Physical activity6 Month Post-OperativeMeasured using 7 days of accelerometry (actigraph).
24 Month Post-Operative Physical activity24 Month Post-OperativeMeasured using 7 days of accelerometry (actigraph).
36 Month Post-Operative Physical activity36 Month Post-OperativeMeasured using 7 days of accelerometry (actigraph).

Other

MeasureTime frameDescription
Pre-operative Dietary IntakePre-operativelyMeasured using three 24 h dietary recalls.
Post-operative Dietary Intake36 Month Post-operativeMeasured using three 24 h dietary recalls.
24 Month Post-operative Dietary Intake24 Month Post-operativeMeasured using three 24 h dietary recalls.
12 Month Post-operative Dietary Intake12 Month Post-operativeMeasured using three 24 h dietary recalls.
1 Month Post-operative Dietary Intake1 Month Post-operativeMeasured using three 24 h dietary recalls.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026