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Completed

NCT Number: NCT02070354

Physical Fitness and Nutrition Intake in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822-2111, United States

About this study

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.

  • New visit with GI Nutrition
  • 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))
  • 6 months after bariatric surgery
  • 12 months after bariatric surgery
  • 24 months after bariatric surgery

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Pre-Operative 6 Min Walk Test

    Time frame: Pre-operative

    6 Min Walk for Distance

  2. 1 Month Post-Operative 6 Min Walk Test

    Time frame: 1 Month Post-Operative

    6 Min Walk for Distance

  3. 6 Month Post-Operative 6 Min Walk Test

    Time frame: 6 Month Post-Operative

    6 Min Walk for Distance

  4. 12 Month Post-Operative 6 Min Walk Test

    Time frame: 12 Month Post-Operative

    6 Min Walk for Distance

  5. 24 Month Post-Operative 6 Min Walk Test

    Time frame: 24 Month Post-Operative

    6 Min Walk for Distance

  6. Peak Oxygen Uptake (peak VO2)

    Time frame: 36 Month Post-Operative

    Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.

Secondary outcomes

  1. Pre-operatively Physical activity

    Time frame: Pre-operatively

    Measured using 7 days of accelerometry (actigraph).

  2. 1 Month Post-Operative Physical activity

    Time frame: 1 Month Post-Operative

    Measured using 7 days of accelerometry (actigraph).

  3. 6 Month Post-Operative Physical activity

    Time frame: 6 Month Post-Operative

    Measured using 7 days of accelerometry (actigraph).

  4. 12 Month Post-Operative Physical activity

    Time frame: 12 Month Post-Operative

    Measured using 7 days of accelerometry (actigraph).

  5. 24 Month Post-Operative Physical activity

    Time frame: 24 Month Post-Operative

    Measured using 7 days of accelerometry (actigraph).

  6. 36 Month Post-Operative Physical activity

    Time frame: 36 Month Post-Operative

    Measured using 7 days of accelerometry (actigraph).

Other outcomes

  1. Pre-operative Dietary Intake

    Time frame: Pre-operatively

    Measured using three 24 h dietary recalls.

  2. 1 Month Post-operative Dietary Intake

    Time frame: 1 Month Post-operative

    Measured using three 24 h dietary recalls.

  3. 12 Month Post-operative Dietary Intake

    Time frame: 12 Month Post-operative

    Measured using three 24 h dietary recalls.

  4. 24 Month Post-operative Dietary Intake

    Time frame: 24 Month Post-operative

    Measured using three 24 h dietary recalls.

  5. Post-operative Dietary Intake

    Time frame: 36 Month Post-operative

    Measured using three 24 h dietary recalls.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
First posted
Feb 25, 2014
Registry last updated
Feb 12, 2016

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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