- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041830
Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity (LFPQ-F)
While Food reward is an important component of the appetite control to consider, there is actually no tool that has been developed in French to perform its evaluation.
The Leeds Food Preference Questionnaire (LFPQ) is a validated and recognized tool to assess food reward, being however developed for British populations.
The aim of this work is to validate a French version of the LFPQ among lean and obese adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Chu Clermont Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 30 and 38 kg.m² for the obese patients and 20 and 25 for the lean ones.
- registered to the national social security system
- Signed consent
Exclusion Criteria:
- eating disorders
- metabolic disease such as hypertension and Type 2 diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: NW (Normal Weight)
20 to 55 years old lean adults
|
the participants will fill in the LFPQ questionnaire before and after a lunch test meal
this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.
|
|
EXPERIMENTAL: OBESE
20 to 55 years old adults with obesity
|
the participants will fill in the LFPQ questionnaire before and after a lunch test meal
this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Food reward
Time Frame: day 1 , day 8
|
The participants will be asked to complete the developed French version of the computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008).
|
day 1 , day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat mass
Time Frame: day 0
|
the percentage of body fat and the quantity of fat mass will be assessed using Bio-impedance (BIA)
|
day 0
|
|
Body fat and fat free mass
Time Frame: day 0
|
the percentage of body fat free and the quantity of fat free mass will be assessed using Bio-impedance (BIA)
|
day 0
|
|
Dietary status
Time Frame: day 0
|
the level of dietary restriction/disinhibition will be assessed using the TFEQ questionnaire.
|
day 0
|
|
Dietary status
Time Frame: day 0
|
the level of dietary restriction/disinhibition will be assessed using the DEBQ questionnaire.
|
day 0
|
|
Hunger
Time Frame: day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
the hunger sensation will be assessed using visual analogue scales of 150 mm.
|
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
|
Satiety
Time Frame: dday 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
the Satiety sensation will be assessed using visual analogue scales of 150 mm.
|
dday 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
|
desire to eat
Time Frame: day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
the desire to eat sensation will be assessed using visual analogue scales of 150 mm.
|
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
|
Prospective Food consumption
Time Frame: day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
the Prospective Food consumption sensation will be assessed using visual analogue scales of 150 mm.
|
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elodie Gentes, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2019 GENTES
- 2019-A00853-54 (OTHER: 2019-A00853-54)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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