Trial record 19 of 36 for:    Open Studies | "Micronutrients"

Physical Fitness and Nutrition Intake in Bariatric Surgery Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Geisinger Clinic
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT02070354
First received: February 19, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Fitness and Macro- and Micro- Nutrient Intake in a Morbidly Obese Bariatric Surgery Population

Resource links provided by NLM:


Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • Pre-Operative 6 Min Walk Test [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    6 Min Walk for Distance

  • 1 Month Post-Operative 6 Min Walk Test [ Time Frame: 1 Month Post-Operative ] [ Designated as safety issue: No ]
    6 Min Walk for Distance

  • 6 Month Post-Operative 6 Min Walk Test [ Time Frame: 6 Month Post-Operative ] [ Designated as safety issue: No ]
    6 Min Walk for Distance

  • 12 Month Post-Operative 6 Min Walk Test [ Time Frame: 12 Month Post-Operative ] [ Designated as safety issue: No ]
    6 Min Walk for Distance

  • 24 Month Post-Operative 6 Min Walk Test [ Time Frame: 24 Month Post-Operative ] [ Designated as safety issue: No ]
    6 Min Walk for Distance

  • Peak Oxygen Uptake (peak VO2) [ Time Frame: 36 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.


Secondary Outcome Measures:
  • Pre-operatively Physical activity [ Time Frame: Pre-operatively ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).

  • 1 Month Post-Operative Physical activity [ Time Frame: 1 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).

  • 6 Month Post-Operative Physical activity [ Time Frame: 6 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).

  • 12 Month Post-Operative Physical activity [ Time Frame: 12 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).

  • 24 Month Post-Operative Physical activity [ Time Frame: 24 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).

  • 36 Month Post-Operative Physical activity [ Time Frame: 36 Month Post-Operative ] [ Designated as safety issue: No ]
    Measured using 7 days of accelerometry (actigraph).


Other Outcome Measures:
  • Pre-operative Dietary Intake [ Time Frame: Pre-operatively ] [ Designated as safety issue: No ]
    Measured using three 24 h dietary recalls.

  • 1 Month Post-operative Dietary Intake [ Time Frame: 1 Month Post-operative ] [ Designated as safety issue: No ]
    Measured using three 24 h dietary recalls.

  • 12 Month Post-operative Dietary Intake [ Time Frame: 12 Month Post-operative ] [ Designated as safety issue: No ]
    Measured using three 24 h dietary recalls.

  • 24 Month Post-operative Dietary Intake [ Time Frame: 24 Month Post-operative ] [ Designated as safety issue: No ]
    Measured using three 24 h dietary recalls.

  • Post-operative Dietary Intake [ Time Frame: 36 Month Post-operative ] [ Designated as safety issue: No ]
    Measured using three 24 h dietary recalls.


Estimated Enrollment: 210
Study Start Date: August 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070354

Contacts
Contact: Teresa Pursel 570-271-5555 ext 59572 tapursel@geisinger.edu
Contact: Jamie Seiler, PAc 570-271-6439 jlseiler@geisinger.edu

Locations
United States, Pennsylvania
Geisinger Clinic Recruiting
Danville, Pennsylvania, United States, 17822-2111
Contact: Teresa Pursel    570-271-5555 ext 59572    tapursel@geisinger.edu   
Contact: Jamie Seiler, PAc    570-271-6439    jlseiler@geisinger.edu   
Principal Investigator: Christopher D Still, DO         
Sponsors and Collaborators
Geisinger Clinic
Investigators
Principal Investigator: Christopher D. Still, DO Geisinger Clinic
  More Information

No publications provided

Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT02070354     History of Changes
Other Study ID Numbers: 2009-0182
Study First Received: February 19, 2014
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Geisinger Clinic:
Obesity
Bariatric surgery
Physical Activity
Nutrition
Weight Loss

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014