Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery

September 27, 2023 updated by: University of Nebraska
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center, Bariatric Center
      • Omaha, Nebraska, United States, 69189-4420
        • University of Nebraska Medical Center, Physical Activity Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients seeking bariatric surgery at University of Nebraska Medical Center/Nebraska Medicine

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human Activity Profile Questionnaire
Time Frame: Baseline - Single time point
Self-report questionnaire - indirect measure of physical activity
Baseline - Single time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire
Time Frame: Baseline - Single time point
Self-report questionnaire - indirect measure of physical activity
Baseline - Single time point
Accelerometer
Time Frame: Baseline - Single time point
Direct measure of physical activity
Baseline - Single time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Laura D Bilek, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0398-19-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small pilot study so we have not identified a plan for sharing the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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