Evaluation of Methods for Measuring Food Reward and Food-related Behavior in Healthy Individuals (PRESET)

September 2, 2019 updated by: Steno Diabetes Center Copenhagen

Evaluation of Methods for Measuring Food Reward and Food-related Behavior in Healthy Individuals - a Substudy of the PRESET Study

Most of the decisions and actions affecting energy balance are driven by implicit and explicit motivational processes. In modern obesogenic environment where highly palatable and energy-dense foods are easily available, it is of great interest to increase the understanding of both implicit and explicit processes of food-related behavior.

The aim of the present study is to examine whether biometric signatures in response to visual food stimuli during the already validated Leeds Food Preference Questionnaire (LFPQ) correlate with liking, wanting, food choice, or subsequent ad libitum food intake of those foods as assessed by the LFPQ and an ad libitum buffet meal.

Study Overview

Status

Completed

Detailed Description

Human behaviour including food reward plays a pivotal role in appetite regulation and the type and amount of food eaten. Food reward is a driver of eating behaviour and is defined as the momentary value of a food to the individual at the time of ingestion. Food reward contains the components of liking and wanting that can exist both with (explicit) and without (implicit) conscious awareness. Most of the daily decisions and actions affecting energy balance are driven by the non-conscious mind. Non-conscious processes are characterised by being unintentional and without awareness of the effects of triggering stimuli, e.g. food items. Contrary, conscious processes are typically assessed through participants' self-reports but limited by accuracy and desire to provide socially desirable answers. In a world of plenty where foods are always easily available with an overtly representation of highly palatable and energy-dense foods it is of great interest to understand the role of the non-conscious mind as a driver of food choice and intake. Intake of highly palatable and energy-dense foods is related to excess energy intake, high body mass index and weight gain. A possible explanation for this is that these foods are overall more rewarding and as a result of this, palatable.

A few previous studies have applied the use of innovative biometric measures, i.e. eye tracking, galvanic skin response, and facial expression to examine behavioural aspects of food intake that are without conscious awareness. However, there is a lack of studies examining how biometric responses to different food groups varying in energy density and palatability correlate with outcomes related to components of food reward and food intake. Therefore, in the present explorative study the above-mentioned biometric measurements will be combined with an existing validated method, the Leeds Food Preference Questionnaire (LFPQ), developed to examine both non-conscious and conscious components of food reward. The LFPQ assess four factors related to food reward within four combined food categories: food choice, implicit and explicit wanting, and explicit liking for high-fat sweet foods, low-fat sweet foods, high-fat savoury foods, and low-fat savoury foods. Biometric measurements of eye tracking can provide measures of attention, measurements of galvanic skin response can provide measures of arousal, and facial expressions analyses can provide information on emotional responses in response to selected stimuli, which in this study constitute pictures of food items. Furthermore, the study will include a taste task including an ad libitum intake of test foods in order to examine responses to actual food intake and to compare these responses to biometric responses to visual food stimuli.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gentofte, Denmark, DK-2810
        • Steno Diabetes Center Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal-weight individuals

Description

Inclusion Criteria:

  • Age: from ≥30 to ≤70 years of age
  • BMI: from 18.5 to 24.9 kg/m2

Exclusion Criteria:

  • Unable to understand the informed consent and the study procedures;
  • Allergic to the food items included in the taste test
  • Self-reported history of an eating disorder in the past three years
  • Self-reported weight change (>5 kg) within three months prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gaze duration bias (ratio)
Time Frame: 0 minutes (fasting)

A measure of attention measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.

Gaze duration bias is calculated as the average gaze duration (ms) to a specific food image relative to the average gaze duration to all images.

A bias score ˃0.5 indicates maintained attention towards a food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates maintained attention towards the other food images.

0 minutes (fasting)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention
Time Frame: 0 minutes (fasting)

Measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.

Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score ˃0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.

0 minutes (fasting)
Arousal
Time Frame: 0 minutes (fasting)

Measured as galvanic skin response (changes in conductivity of the skin) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.

Includes the following parameters: Presence of a peak (yes/no), peak count (n), peaks/min, peak (ms), peak amplitude (μS), peak onset (ms), peak offset (ms), duration (ms), tonic signal (μS).

The presence of a peak, the magnitude of the peak as well as the duration of the peak are measures of arousal (includes all the parameters listed above). The greater the response the higher the arousal.

0 minutes (fasting)
Emotions
Time Frame: 0 minutes (fasting)

Emotions including anger, sadness, disgust, joy, surprise, fear, contempt as well as facial expression metrics (actions units) are determined by facial expression analysis using computer-vision algorithms (AFFDEX) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.

Results represent the probability the emotions and facial expression metrics were expressed (range: 0-100; 0=it was not expressed, 100=it was expressed, 50=50% likelihood that it was expressed).

0 minutes (fasting)
Food choice
Time Frame: 0 minutes (fasting)
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
0 minutes (fasting)
Reaction time (ms)
Time Frame: 0 minutes (fasting)
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire.
0 minutes (fasting)
Implicit wanting
Time Frame: 0 minutes (fasting)

Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm).

In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value)

0 minutes (fasting)
Explicit liking
Time Frame: 0 minutes (fasting)
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
0 minutes (fasting)
Explicit wanting
Time Frame: 0 minutes (fasting)
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
0 minutes (fasting)
Subjective appetite
Time Frame: 0 minutes (fasting)
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".
0 minutes (fasting)
Body weight (kg)
Time Frame: 0 minutes (fasting)
Body weight is measured on a digital scale
0 minutes (fasting)
Body mass index (kg/m^2)
Time Frame: 0 minutes (fasting)
Calculated from body weight (kg) and height (m)
0 minutes (fasting)
Fat mass (kg)
Time Frame: 0 minutes (fasting)
Measured by Dual-energy X-ray Absorptiometry
0 minutes (fasting)
Fat percentage (%)
Time Frame: 0 minutes (fasting)
Measured by Dual-energy X-ray Absorptiometry
0 minutes (fasting)
Fat free mass (kg)
Time Frame: 0 minutes (fasting)
Measured by Dual-energy X-ray Absorptiometry
0 minutes (fasting)
Waist circumference (cm)
Time Frame: 0 minutes (fasting)
Measured using tape measure
0 minutes (fasting)
Hip circumference (cm)
Time Frame: 0 minutes (fasting)
Measured using tape measure
0 minutes (fasting)
Systolic blood pressure (mmHg)
Time Frame: 0 minutes (fasting)
Measured under resting and fasting conditions
0 minutes (fasting)
Diastolic blood pressure (mmHg)
Time Frame: 0 minutes (fasting)
Measured under resting and fasting conditions
0 minutes (fasting)
Heart rate (bpm)
Time Frame: 0 minutes (fasting)
Measured under resting and fasting conditions
0 minutes (fasting)
HbA1c (mmol/mol and %)
Time Frame: 0 minutes (fasting)
Hemoglobin A1c
0 minutes (fasting)
Sleep quality
Time Frame: 0 minutes (fasting)
Assessed using the Pittsburgh Sleep Quality Index. The questionnaire covers sleep quality and sleep disturbances over the preceding month and includes 19 individual items that generate seven scores weighted on a 0-3 scale. The sum of the component scores yields a total score of 0-21, and the higher the score, the poorer the sleep quality. The questionnaire also covers bedtime (hh:mm), sleep onset latency (minutes/night), wake-up (hh:mm); sleep duration (hours and minutes per night).
0 minutes (fasting)
Sleepiness
Time Frame: 0 minutes (fasting)
Assessed using the Epworth Sleepiness Scale. The questionnaire describes eight different situations of everyday life, and participants are asked to rate how likely they would doze off or fall asleep in each situation on a 0-3 scale. The sum of the scores yields a total score of 0-24, with higher scores indicative of greater daytime sleepiness.
0 minutes (fasting)
Self-reported health
Time Frame: 0 minutes (fasting)
Assessed using the Short Form Health Survey (SF-36). The questionnaire covers self-reported health status and the response format is a Likert-type scale e.g. question regarding overall health from 1=excellent to 5=poor and binary scales (yes/no) e.g. "difficulties performing daily tasks".
0 minutes (fasting)
Physical activity
Time Frame: Minimum 6 hours after test day
Assessed using the Recent Physical Activity Questionnaire. The questionnaire covers physical activity during work and in transport and leisure-time domains. The response format is a Likert-type scale e.g. 1=never and 5=always and participants are also asked about distance to work and typical mode of transportation. The time spent (minutes/day) on different modes of transportation or work-related or leisure-time physical activities and exercise as well as intensity (sedentary, light, moderate, vigorous) of the activities can be calculated.
Minimum 6 hours after test day
Chronotype
Time Frame: 0 minutes (fasting)
Assessed using the Munich Chronotype Questionnaire. The primary outcome is sleep midpoint (hh:mm) calculated based on participants' registration of habitual bedtime (hh:mm), sleep onset (hh:mm), sleep onset latency (minutes), wake-up (hh:mm), time from wake-up to out of bed (minutes). The questionnaire also covers use of sleep medicine and intake of alcohol and coffee/tea (units/day, units/ week, units/months), type of transportation to work (car/bus/train, walking/bicycling or work from home) and duration of transportation (minutes/day).
0 minutes (fasting)
Night eating
Time Frame: Minimum 6 hours after test day
Assessed using the Night Eating Questionnaire. The questionnaire covers hunger and craving for foods at different times during the day and night. The response format is a Likert-type scale ranging from e.g. 0=not at all to 4=very much.
Minimum 6 hours after test day
Eating behavior
Time Frame: Minimum 6 hours after test day
Assessed using the Dutch Eating Behavior Questionnaire. The questionnaire consists of 33 questions and assess restrained (10 items), emotional (13 item), and external (10 items) eating behavior. The response format is a Likert-type scale ranging from 1=never to 5= very often. The greater the total score within each category the greater degree of e.g. dietary restraint.
Minimum 6 hours after test day
Control over eating
Time Frame: Minimum 6 hours after test day
Assessed using the Control Over Eating Questionnaire. Control of eating and the degree of food cravings are assessed using the 21-item questionnaire which includes questions related to food cravings, control of eating, appetite and overall mood. Based on the previous 7 days, participants are asked to rate 20 questions on a 100 mm visual analogue scale (VAS). One question is open-ended. The VAS range is 0-100 and each end represent the extremes e.g. "how difficult is it to control eating": "Not difficult at all" to "It has never been more difficult".
Minimum 6 hours after test day
Socioeconomic status
Time Frame: 0 minutes (fasting)
Assessed using a questionnaire assessing self-reported educational level (categorical), main occupation (categorical), civil status (categorical), ethnicity (categorical), living arrangement (categorical), children (n), personal income (DKK), household income (DKK), sex (male/female), and age (years).
0 minutes (fasting)
Total energy intake (kcal or kJ)
Time Frame: 60 minutes after basal assessments
Total energy intake during an ad libitum buffet meal provided after all basal assessments
60 minutes after basal assessments
Energy intake from specific food categories (kcal or kJ)
Time Frame: 60 minutes after basal assessments
Energy intake from different food categories (high fat-savoury, high fat-sweet, low fat-savoury, low fat-sweet) during an ad libitum buffet meal provided after all basal assessments
60 minutes after basal assessments
Explicit liking
Time Frame: 60 minutes after basal assessments
Explicit liking of 8 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined during an ad libitum buffet meal provided after all basal assessments. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes. Question: "how pleasant is the taste of the food right now?" Answer: "not pleasant at all" (rated 0 on the 0-100 scale) to "very pleasant" (rated 100 on the 0-100 scale).
60 minutes after basal assessments
Explicit wanting
Time Frame: 60 minutes after basal assessments
Explicit wanting of 8 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined during ad libitum buffet meal provided after all basal assessments. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes. Question: "How much more do you think you can eat of the food right now?" Answer: "nothing at all" (rated 0 on the 0-100 scale) to "very much" (rated 100 on the 0-100 scale).
60 minutes after basal assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2018

Primary Completion (ACTUAL)

August 29, 2019

Study Completion (ACTUAL)

August 29, 2019

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H-18026293_substudy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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