NCT02070354

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

February 19, 2014

Last Update Submit

February 11, 2016

Conditions

Obesity

Keywords

ObesityBariatric surgeryPhysical ActivityNutritionWeight Loss

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • Pre-operatively Physical activity

    Pre-operatively

  • 1 Month Post-Operative Physical activity

    1 Month Post-Operative

  • 6 Month Post-Operative Physical activity

    6 Month Post-Operative

  • 12 Month Post-Operative Physical activity

    12 Month Post-Operative

  • 24 Month Post-Operative Physical activity

    24 Month Post-Operative

  • +1 more secondary outcomes

Other Outcomes (5)

  • Pre-operative Dietary Intake

    Pre-operatively

  • 1 Month Post-operative Dietary Intake

    1 Month Post-operative

  • 12 Month Post-operative Dietary Intake

    12 Month Post-operative

  • +2 more other outcomes

Study Arms (6)

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 Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822-2111, United States

Location

MeSH Terms

Conditions

ObesityMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Study Officials

  • Christopher D. Still, DO

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 25, 2014

Study Start

August 1, 2009

Primary Completion

March 1, 2014

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

US(1)