Bariatric Surgery CandidateNCT03981978
Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery
An observational study of Bariatric Surgery Candidate and Obesity, run by University of Nebraska at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seeking bariatric surgery at University of Nebraska Medical Center/Nebraska Medicine
Who may be able to join
- 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.
Who cannot join
- Age < 19
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center, Bariatric Center
Omaha, Nebraska, 68198
University of Nebraska Medical Center, Physical Activity Lab
Omaha, Nebraska, 69189-4420
About this study
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Obesity
- Being tested
- Physical Activity
- Keywords
- physical activity, accelerometer, bariatric surgery, obesity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Also called Human Activity Profile Questionnaire, Godin-Shephard Leisure Time Physical Activity Questionnaire
Self-report questionnaires assessing physical activity level.
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Activity Profile Questionnaire
Self-report questionnaire - indirect measure of physical activity
Measured: Baseline - Single time point
Secondary outcomes (2)
Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire
Self-report questionnaire - indirect measure of physical activity
Measured: Baseline - Single time point
Accelerometer
Direct measure of physical activity
Measured: Baseline - Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura D Bilek, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981978
- Sponsor's protocol ID
- 0398-19-EP
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03981978
- Acronym / sponsor ID
- 0398-19-EP
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- physical activity, accelerometer, bariatric surgery, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jun 2019 (actual)
- 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 study is to determine the validity of the Human Activity Profile and Godin self-report questionnaires of physical activity in persons seeking metabolic surgery.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking bariatric surgery at University of Nebraska Medical Center/Nebraska Medicine
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityAlso: Human Activity Profile Questionnaire, Godin-Shephard Leisure Time Physical Activity QuestionnaireSelf-report questionnaires assessing physical activity level. | Behavioural | – |
Primary outcome
Human Activity Profile Questionnaire
Time frame: Baseline - Single time point
Self-report questionnaire - indirect measure of physical activity
2 secondary outcomes
Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire
Time frame: Baseline - Single time point
Accelerometer
Time frame: Baseline - Single time point
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 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Laura D Bilek, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, run by University of Nebraska at 2 sites 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 6 inclusion and 1 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Human Activity Profile Questionnaire (time frame: Baseline - Single time point). 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 29 Sep 2023.