Obesity, MorbidNCT05137405
THE IMPACT OF COVID-19 AMONG OBESE PATIENTS
An observational study of Obesity, Morbid, run by University of Foggia at 1 site in Italy.
Trial summary
BACKGROUND: Stay-at-home orders in response to the Coronavirus 2 (SARSCoV-2) have forced abrupt changes to daily routines. The aim of our study is to evaluate the impact of the Stay-at-home orders on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2020to 1 Dec 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: An online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020.
Who may be able to join
- Alle obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic from March to May 2020
Who cannot join
- Patients underwent bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HOW THE IMPACT OF COVID-19 HOME STAY ORDERS IS AFFECTING THE PHYSICAL, MENTAL AND FINANCIAL HEALTH AMONG OBESE PATIENTS?
BACKGROUND: Stay-at-home orders in response to the Coronavirus 2 (SARSCoV-2) have forced abrupt changes to daily routines.
The aim of our study is to evaluate the impact of the Stay-at-home orders on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic.
MATERIALS AND METHODS: In this observational retrospective study, from the 9th of March to 18th May 2020, the patients of our Department were invited to answer to a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices
- Conditions
- Obesity, Morbid
- Being tested
- Sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
An online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020.
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the impact of the Lock-down period on the mental and physical health of obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences during covid-19 pandemic.
we have used a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices
Measured: March - May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start8 Mar 2020
- Primary completion18 May 2020
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137405
- Sponsor's protocol ID
- 2
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOW THE IMPACT OF COVID-19 HOME STAY ORDERS IS AFFECTING THE PHYSICAL, MENTAL AND FINANCIAL HEALTH AMONG OBESE PATIENTS?
- ClinicalTrials.gov ID
- NCT05137405
- Acronym / sponsor ID
- 2
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 8 Mar 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 30 Nov 2021 (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.
BACKGROUND: Stay-at-home orders in response to the Coronavirus 2 (SARSCoV-2) have forced abrupt changes to daily routines.
The aim of our study is to evaluate the impact of the Stay-at-home orders on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic.
MATERIALS AND METHODS: In this observational retrospective study, from the 9th of March to 18th May 2020, the patients of our Department were invited to answer to a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- An online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020.
Key inclusion criteria (1 listed)
- Alle obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic from March to May 2020
Key exclusion criteria (1 listed)
- Patients underwent bariatric surgery
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 |
|---|---|---|
| Sleeve gastrectomyAn online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020. | Procedure or surgery | – |
Primary outcome
evaluate the impact of the Lock-down period on the mental and physical health of obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences during covid-19 pandemic.
Time frame: March - May 2020
we have used a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by University of Foggia at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
evaluate the impact of the Lock-down period on the mental and physical health of obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences during covid-19 pandemic. (time frame: March - May 2020). 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 30 Nov 2021.