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Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity (LFPQ-F)

Primary Purpose

Normal Weight Adults, Adults With Obesity

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visit 1
Visit 2
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Weight Adults focused on measuring Appetite, Food Reward, Methodological approach

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Clermont Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NW (Normal Weight)

OBESE

Arm Description

20 to 55 years old lean adults

20 to 55 years old adults with obesity

Outcomes

Primary Outcome Measures

Change in Food reward
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).

Secondary Outcome Measures

Body fat mass
the percentage of body fat and the quantity of fat mass will be assessed using Bio-impedance (BIA)
Body fat and fat free mass
the percentage of body fat free and the quantity of fat free mass will be assessed using Bio-impedance (BIA)
Dietary status
the level of dietary restriction/disinhibition will be assessed using the TFEQ questionnaire.
Dietary status
the level of dietary restriction/disinhibition will be assessed using the DEBQ questionnaire.
Hunger
the hunger sensation will be assessed using visual analogue scales of 150 mm.
Satiety
the Satiety sensation will be assessed using visual analogue scales of 150 mm.
desire to eat
the desire to eat sensation will be assessed using visual analogue scales of 150 mm.
Prospective Food consumption
the Prospective Food consumption sensation will be assessed using visual analogue scales of 150 mm.

Full Information

First Posted
July 29, 2019
Last Updated
February 16, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK, Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex
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1. Study Identification

Unique Protocol Identification Number
NCT04041830
Brief Title
Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity
Acronym
LFPQ-F
Official Title
Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
The sanitary conditions and material restrictions imposed by the CHU and by the university laboratories drastically hampered the realization of this work (with restricted access to the laboratory/department).
Study Start Date
December 8, 2019 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK, Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
50 lean and 50 patients with obesity between 20 and 55 years old (50% women and 50% men), will be recruited. After an evaluation of their body composition by impedance meter, and of their dietary status by questionnaires (TFEQ/DEBQ), they will be asked to perform twice the same experimental sessions. They will be asked during this session to arrive at 08:00 am after a 12-hour fast and will receive a calibrated breakfast. Before and after a lunch calibrated meal, they will be asked to perform the French version of the computerized questionnaire LFPQ. Appetite feelings will be assessed at regular intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Weight Adults, Adults With Obesity
Keywords
Appetite, Food Reward, Methodological approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NW (Normal Weight)
Arm Type
Experimental
Arm Description
20 to 55 years old lean adults
Arm Title
OBESE
Arm Type
Experimental
Arm Description
20 to 55 years old adults with obesity
Intervention Type
Behavioral
Intervention Name(s)
Visit 1
Intervention Description
the participants will fill in the LFPQ questionnaire before and after a lunch test meal
Intervention Type
Behavioral
Intervention Name(s)
Visit 2
Intervention Description
this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.
Primary Outcome Measure Information:
Title
Change in Food reward
Description
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).
Time Frame
day 1 , day 8
Secondary Outcome Measure Information:
Title
Body fat mass
Description
the percentage of body fat and the quantity of fat mass will be assessed using Bio-impedance (BIA)
Time Frame
day 0
Title
Body fat and fat free mass
Description
the percentage of body fat free and the quantity of fat free mass will be assessed using Bio-impedance (BIA)
Time Frame
day 0
Title
Dietary status
Description
the level of dietary restriction/disinhibition will be assessed using the TFEQ questionnaire.
Time Frame
day 0
Title
Dietary status
Description
the level of dietary restriction/disinhibition will be assessed using the DEBQ questionnaire.
Time Frame
day 0
Title
Hunger
Description
the hunger sensation will be assessed using visual analogue scales of 150 mm.
Time Frame
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Title
Satiety
Description
the Satiety sensation will be assessed using visual analogue scales of 150 mm.
Time Frame
dday 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Title
desire to eat
Description
the desire to eat sensation will be assessed using visual analogue scales of 150 mm.
Time Frame
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Title
Prospective Food consumption
Description
the Prospective Food consumption sensation will be assessed using visual analogue scales of 150 mm.
Time Frame
day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie Gentes
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity

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