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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03981978
Other study ID # 0398-19-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
Self-report questionnaires assessing physical activity level.

Locations

Country Name City State
United States University of Nebraska Medical Center, Bariatric Center Omaha Nebraska
United States University of Nebraska Medical Center, Physical Activity Lab Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Human Activity Profile Questionnaire Self-report questionnaire - indirect measure of physical activity Baseline - Single time point
Secondary Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire Self-report questionnaire - indirect measure of physical activity Baseline - Single time point
Secondary Accelerometer Direct measure of physical activity Baseline - Single time point
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