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Trial record 10 of 52199 for:    questionnaire

Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03981978
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Laura D. Bilek, PhD, PT, University of Nebraska

Brief Summary:
The purpose of this study is to determine the validity of the Human Activity Profile and Godin self-report questionnaires of physical activity in persons seeking metabolic surgery.

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Obesity Behavioral: Physical Activity

Detailed Description:
This cross-sectional study will collect subject's medical history, anthropometric measurements, physical activity data through an accelerometer worn on the wrist and indirect physical activity measures via the Human Activity Profile and Godin self-report questionnaires. We will collect clinical information from the medical record including predictors of physical activity level in obesity such as nutritional lab and co-morbid conditions.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Physical Activity
    Self-report questionnaires assessing physical activity level.
    Other Names:
    • Human Activity Profile Questionnaire
    • Godin-Shephard Leisure Time Physical Activity Questionnaire


Primary Outcome Measures :
  1. Human Activity Profile Questionnaire [ Time Frame: Baseline - Single time point ]
    Self-report questionnaire - indirect measure of physical activity


Secondary Outcome Measures :
  1. Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire [ Time Frame: Baseline - Single time point ]
    Self-report questionnaire - indirect measure of physical activity

  2. Accelerometer [ Time Frame: Baseline - Single time point ]
    Direct measure of physical activity



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients seeking bariatric surgery at University of Nebraska Medical Center/Nebraska Medicine
Criteria

Inclusion Criteria:

  • Age >19
  • BMI > 30
  • Able to speak and understand English
  • Consent to provide access to medical records for medical history
  • Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine
  • Consent to wear an activity tracker device for 7 days after designated visits.

Exclusion Criteria:

• Age < 19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981978


Contacts
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Contact: Laura D Bilek, PhD 402-559-6923 lbilek@unmc.edu
Contact: Laura E Flores, BA Laura.Flores@unmc.edu

Locations
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United States, Nebraska
Bariatric Center, Nebraska Medicine Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Laura D Bilek, PhD    402-559-5978    lbilek@unmc.edu   
Contact: Melissa Cole, MA    402-559-5978    mel.meisinger@unmc.edu   
Division of Physical Therapy Education Physical Activity Lab
Omaha, Nebraska, United States, 69189-4420
Sponsors and Collaborators
University of Nebraska

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Responsible Party: Laura D. Bilek, PhD, PT, Associate Dean for Research, University of Nebraska
ClinicalTrials.gov Identifier: NCT03981978     History of Changes
Other Study ID Numbers: 398-19-EP
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is a small pilot study so we have not identified a plan for sharing the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura D. Bilek, PhD, PT, University of Nebraska:
physical activity
accelerometer
bariatric surgery
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms