NCT06243055

Brief Summary

The study is a Turkish validity and reliability study of the Laval questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

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

Study Start

First participant enrolled

November 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
Last Updated

February 6, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 16, 2024

Last Update Submit

January 26, 2024

Conditions

ObesityQuality of Life

Keywords

obesityquality of lifevalidity and reliability

Outcome Measures

Primary Outcomes (1)

  • the Kaiser-Meyer-Olkin (KMO) test

    to check the suitability of the sample number for analysis

    1 year

Interventions

questionnareOTHER

laval questionnare

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

body mass index (BMI) ≥ 30 kg/m2

You may qualify if:

  • volunteering, being literate
  • age ≥ 18 and age ≤ 75
  • body mass index (BMI) ≥ 30 kg/m2
  • ability to follow instructions to fill out questionnaires.

You may not qualify if:

  • affected by psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziemir Municipality

Izmir, Gaziemir, Turkey (Türkiye)

Location

İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre

Bayraklı, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
İzmir Bayraklı District Health Directorate

Study Record Dates

First Submitted

January 16, 2024

First Posted

February 6, 2024

Study Start

November 15, 2021

Primary Completion

March 22, 2022

Study Completion

September 20, 2023

Last Updated

February 6, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
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

Locations

TU(2)