ObesityNCT02070354
Physical Fitness and Nutrition Intake in Bariatric Surgery Population
An observational study of Obesity, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Physical Activity, Nutrition, Weight Loss
- Medical subject headings
- Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pre-Operative 6 Min Walk Test
6 Min Walk for Distance
Measured: Pre-operative
1 Month Post-Operative 6 Min Walk Test
6 Min Walk for Distance
Measured: 1 Month Post-Operative
6 Month Post-Operative 6 Min Walk Test
6 Min Walk for Distance
Measured: 6 Month Post-Operative
12 Month Post-Operative 6 Min Walk Test
6 Min Walk for Distance
Measured: 12 Month Post-Operative
24 Month Post-Operative 6 Min Walk Test
6 Min Walk for Distance
Measured: 24 Month Post-Operative
Peak Oxygen Uptake (peak VO2)
Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.
Measured: 36 Month Post-Operative
Secondary outcomes (6)
Pre-operatively Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: Pre-operatively
1 Month Post-Operative Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: 1 Month Post-Operative
6 Month Post-Operative Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: 6 Month Post-Operative
12 Month Post-Operative Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: 12 Month Post-Operative
24 Month Post-Operative Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: 24 Month Post-Operative
36 Month Post-Operative Physical activity
Measured using 7 days of accelerometry (actigraph).
Measured: 36 Month Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startAug 2009
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher D. Still, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070354
- Sponsor's protocol ID
- 2009-0182
- Status last verified
- Feb 2016
- First submitted
- 19 Feb 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness and Macro- and Micro- Nutrient Intake in a Morbidly Obese Bariatric Surgery Population
- ClinicalTrials.gov ID
- NCT02070354
- Acronym / sponsor ID
- 2009-0182
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Physical Activity, Nutrition, Weight Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-Operative 6 Min Walk Test
Time frame: Pre-operative
6 Min Walk for Distance
1 Month Post-Operative 6 Min Walk Test
Time frame: 1 Month Post-Operative
6 Min Walk for Distance
6 Month Post-Operative 6 Min Walk Test
Time frame: 6 Month Post-Operative
6 Min Walk for Distance
12 Month Post-Operative 6 Min Walk Test
Time frame: 12 Month Post-Operative
6 Min Walk for Distance
24 Month Post-Operative 6 Min Walk Test
Time frame: 24 Month Post-Operative
6 Min Walk for Distance
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.
6 secondary outcomes
Pre-operatively Physical activity
Time frame: Pre-operatively
1 Month Post-Operative Physical activity
Time frame: 1 Month Post-Operative
6 Month Post-Operative Physical activity
Time frame: 6 Month Post-Operative
12 Month Post-Operative Physical activity
Time frame: 12 Month Post-Operative
24 Month Post-Operative Physical activity
Time frame: 24 Month Post-Operative
36 Month Post-Operative Physical activity
Time frame: 36 Month Post-Operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D. Still, DO principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Operative 6 Min Walk Test (time frame: Pre-operative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.