NCT03981978

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

June 7, 2019

Last Update Submit

September 27, 2023

Conditions

Bariatric Surgery CandidateObesity

Keywords

physical activityaccelerometerbariatric surgeryobesity

Outcome Measures

Primary Outcomes (1)

  • Human Activity Profile Questionnaire

    Self-report questionnaire - indirect measure of physical activity

    Baseline - Single time point

Secondary Outcomes (2)

  • Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire

    Baseline - Single time point

  • Accelerometer

    Baseline - Single time point

Interventions

Physical ActivityBEHAVIORAL

Self-report questionnaires assessing physical activity level.

Also known as: Human Activity Profile Questionnaire, Godin-Shephard Leisure Time Physical Activity Questionnaire

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Nebraska Medical Center, Bariatric Center

Omaha, Nebraska, 68198, United States

Location

University of Nebraska Medical Center, Physical Activity Lab

Omaha, Nebraska, 69189-4420, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura D Bilek, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 11, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)