ObesityNCT06243055
Reliability and Validity of the Turkish Version of the Laval
An observational study of Obesity and Quality of Life, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The study is a Turkish validity and reliability study of the Laval questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Quality of Life
- What is being tested?
- questionnare
- How many people
- 235 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 20 Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: body mass index (BMI) ≥ 30 kg/m2
Who may be able to join
- volunteering, being literate
- age ≥ 18 and age ≤ 75
- body mass index (BMI) ≥ 30 kg/m2
- ability to follow instructions to fill out questionnaires.
Who cannot join
- affected by psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre
Bayraklı, İ̇zmi̇r
Gaziemir Municipality
Izmir, Gaziemir
About this study
Official title: Reliability and Validity of the Turkish Version of the Laval Quality of Life Questionnaire for Obesity
The study is a Turkish validity and reliability study of the Laval questionnaire.
Read the detailed description
the study was planned as a student's master thesis. the whole study was carried out by us. all evaluations were completed. all analyses were completed. It is an observational study. It is a survey study.The study data were entered retrospectively.
Research İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre (1 October 2021 - 15 November 2021) and Gaziemir Municipality (15 November 2021 - 15 March 2022) was conducted. Dokuz Eylül University Ethics Committee accepted the study on 22.12.2021 with the decision number 2021/38-08. People with Body Mass Index ≥ 30 kg/m2 and who met the inclusion/exclusion criteria were included in the study. In addition to the Laval Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific Quality of Life Scale were used. For the adaptation of the Turkish version of the questionnaire, first, language validity was ensured by back translation method.
- Conditions
- Obesity, Quality of Life
- Being tested
- questionnare
- Keywords
- obesity, quality of life, validity and reliability
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnareOther
laval questionnare
questionnareOther
Obese-Specific Quality of Life
questionnareOther
SF-12 Quality of Life scale
What is being measured
The primary outcome is the main question the study is designed to answer.
the Kaiser-Meyer-Olkin (KMO) test
to check the suitability of the sample number for analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Nov 2021
- Primary completion22 Mar 2022
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE KAYALI VATANSEVER, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243055
- Sponsor's protocol ID
- 6617-GOA
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to the Laval Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific Quality of Life Scale were used.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Laval Quality of Life Questionnaire for Obesity
- ClinicalTrials.gov ID
- NCT06243055
- Acronym / sponsor ID
- 6617-GOA
- Conditions
- Obesity, Quality of Life
- Keywords
- obesity, quality of life, validity and reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 6 Feb 2024 (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 study is a Turkish validity and reliability study of the Laval questionnaire.
Detailed description
the study was planned as a student's master thesis. the whole study was carried out by us. all evaluations were completed. all analyses were completed. It is an observational study. It is a survey study.The study data were entered retrospectively.
Research İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre (1 October 2021 - 15 November 2021) and Gaziemir Municipality (15 November 2021 - 15 March 2022) was conducted. Dokuz Eylül University Ethics Committee accepted the study on 22.12.2021 with the decision number 2021/38-08. People with Body Mass Index ≥ 30 kg/m2 and who met the inclusion/exclusion criteria were included in the study. In addition to the Laval Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific Quality of Life Scale were used. For the adaptation of the Turkish version of the questionnaire, first, language validity was ensured by back translation method.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- body mass index (BMI) ≥ 30 kg/m2
Key inclusion criteria (4 listed)
- volunteering, being literate
- age ≥ 18 and age ≤ 75
- body mass index (BMI) ≥ 30 kg/m2
- ability to follow instructions to fill out questionnaires.
Key exclusion criteria (1 listed)
- affected by psychiatric illness
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 |
|---|---|---|
| questionnarelaval questionnare | Other | – |
| questionnareObese-Specific Quality of Life | Other | – |
| questionnareSF-12 Quality of Life scale | Other | – |
Primary outcome
the Kaiser-Meyer-Olkin (KMO) test
Time frame: 1 year
to check the suitability of the sample number for analysis
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 6 Feb 2024.
- Individual participant dataSharing planned: Yes. In addition to the Laval Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific Quality of Life Scale were used.
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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.
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 Obesity and Quality of Life, run by Ege University at 2 sites in Turkey (Türkiye).
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 4 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 6 Feb 2024. 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 Turkey (Türkiye). 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?
the Kaiser-Meyer-Olkin (KMO) test (time frame: 1 year). 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 6 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.