Development and Validation of a Brief Food Noise Questionnaire
Conditions: Eating Behavior
Sponsor: Pennington Biomedical Research Center

 
 
 
 
 
Development and Validation of a Brief  
Food Noise Questionnaire 
 
NCT06315907 
 
March 5, 2024  
 

Protocol Full Title: 
Development and validation of a brief food noise 
questionnaire
Principal Investigator Name: 
Corby K. Martin, PhD, Pennington Biomedical Research 
Center
Co-Investigators: 
Hanim Ecem Diktas, PhD, Pennington Biomedical Research 
Center
Monique M. LeBlanc, PhD, Pennington Biomedical Adjunct 
Faculty, Southeastern Louisiana University, 
Gary D. Foster, PhD, WW International, Inc., 
Michelle Cardel, PhD, WW International, Inc.
Protocol Version Date: 
January 26, 2024
Background Information
As weight loss drugs have become increasingly commonplace and positive results are observed in real-
life clinical settings1, news articles have documented anecdotes from patients who reported having 
“food noise” in their heads quieted after taking these drugs (particularly semaglutide) for weight 
management2–4. Based on these anecdotal reports, one previous review defined food noise as 
“heightened and/or persistent manifestations of food cue reactivity, often resulting in intrusive food 
thoughts and maladaptive eating behaviors5.” This definition, however, views food noise largely as a cue 
reactivity phenomenon, which is not inclusive of reports of food noise from patients since they report 
experiencing food noise even in the absence of food cues6. Many patients also report that food noise 
diminishes or disappears when they take GLP-1 receptor agonists2–4,6, and patients report that food 
noise can be fairly constant and is frequently intrusive. They also indicate that food noise can disrupt 
daily life or quality of life and it can make engaging in health behaviors difficult. Thus, we propose the 
following definition: “Constant, intrusive thoughts about food that are disruptive to daily life and make 
healthful behaviors extremely difficult.”
Currently, there are no validated questionnaires to assess food noise. As such, the purpose of this study 
is to develop and validate a brief food noise questionnaire. A total of 400 participants will be asked to 
complete the new food noise questionnaire. A subsample will also be asked to complete the 
questionnaire a second time to evaluate test-retest reliability. Similarly, a separate subsample will also 
complete additional questionnaires to test convergent and discriminant validity. These details are 
outlined below. 
Study Objectives
The purpose of the research reported herein is to develop and test the reliability and validity of a brief 
questionnaire to measure food noise. 
Study Timeline
We expect the study to be completed within 6 months.  
 
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Setting
This study consists of online electronic surveys (required for participation).
Study Endpoints
Study endpoints include participants’ responses to the food noise items and the questionnaires outlined 
herein. Demographic information will be collected and analyzed, including education level, household 
income, employment status, age, sex, race, height, weight, weight history (e.g., history of weight gain or 
loss, diet attempts, weight fluctuations, disordered eating, etc.), medical conditions, and medication 
usage.  
Prior Approvals
This study will receive Institutional Review Board approval from Pennington Biomedical Research Center 
prior to survey distribution and data collection.
Procedures and Recruitment Methods
Reliability Tests: 
a.
Internal consistency reliability (Cronbach’s Alpha)7 will be assessed with the entire dataset 
(N=400). Sample sizes were developed based on the assumption that the instrument would have 
no more than ten items and only one factor8.
b.
Test re-test reliability will be assessed by administering the food noise questionnaire two times, 
approximately 7 days apart, in a subsample of 150 participants (see Table 1). 
Validity Tests:
a.
The construct will be first defined via a literature review and ongoing discussions with the study 
team. Then, approximately 10-15 items will be generated, which will likely be reduced to ~6-8 
items prior to subsequent item analysis. Items that the team does not believe represent the 
construct of interest will be eliminated. 
b.
Content validity will be examined by asking 4-6 experts and ~10 laypersons to review the items 
and report if they adequately assess the construct of interest. This will be completed either via 
interview, focus groups, and/or ratings on a questionnaire that includes open-ended questions. 
c.
Subsequently, an exploratory factor analysis (EFA) will be conducted with 150 participants from 
the main sample, followed by a confirmatory factor analysis (CFA) with the remaining 250 people 
from the main sample.   
d.
Construct validity (n=250). In addition to completing the demographics form and the new food 
noise questionnaire, 250 participants from the sample will also complete the following five 
instruments to assess convergent and discriminant validity. 
a.
Convergent validity will be assessed with the following instruments. 
i.
The Food Preoccupation Questionnaire9. This questionnaire is a 26 item self-
reported measure of thoughts about food. Of these, 3 assess frequency, and 23 
assess emotional valence of thoughts, which could be either positive (9 items), 
negative (9 items) or neutral (5 items). The response options are rated on a 5-
point scale (‘completely disagree’, ‘disagree a bit’, ‘neither agree nor disagree’, 
‘agree a bit’, ‘completely agree’). Four items were reverse scored. For the 
present validation study, only the 3 frequency subscale items will be 
administered. 
 
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ii.
Food Craving Questionnaire – Trait (FCQ-T)10. The FCQ-T measures the stable 
(trait) dimensions of food cravings. The FCQ-T consists of 39 items and items are 
scored on a 6-point scale ranging from never to always. Its original form 
comprises nine subscales measuring food cravings as (1) intentions to consume 
food, (2) anticipation of positive reinforcement, (3) relief from negative states, 
(4) lack of control over eating, (5) preoccupation with food, (6) hunger, (7) 
emotions, (8) cues that trigger cravings, and (9) guilt. For the present validation 
study, only the six items on the preoccupation with food subscale will be 
administered. 
b.
Discriminant validity will be assessed with the following instruments.  
i.
The Patient Health Questionnaire (PHQ-8)11: The PHQ-8 contains the first eight 
items of the PHQ-9 and it does not assess suicidal ideation or intent. 
ii.
The Perceived Stress Scale (PSS)12. The PSS is a 10-item instrument designed to 
measure the degree to which situations in one’s life are considered stressful. 
iii.
General Anxiety Disorder-7 (GAD-7)13. The GAD-7 is a 7-item self-report 
questionnaire, assessing anxiety symptoms in the past two weeks (e.g. “Feeling 
nervous, anxious, or on the edge”). 
As mentioned above, all 400 participants will first complete the demographic information survey and 
the new food noise questionnaire. Of these 400 participants, 250 participants will then complete the 
questions outlined above to assess construct validity. The remaining 150 participants will be asked to 
complete the food noise questionnaire again in approximately 1 week to assess test-retest reliability. 
Participants will be offered an opportunity to complete the survey via a third-party panel provider that is 
in partnership with the WW team. The survey will be conducted using the Qualtrics system, which is a 
HIPAA compliant system14. Participants will be offered an opportunity to complete the survey on 
Qualtrics secure web application. Participants will learn of the study via email from the panel provider, 
which is the company who will administer the survey and who retains an email list of possible survey 
respondents. We aim to recruit a heterogeneous sample of participants. In line with the latest Centers 
for Disease Control and Prevention (CDC)14 and U.S. Census Bureau report15, our goal is to recruit a 
balanced sample of participants in terms of BMI, race, and ethnicity. Thus, recruitment will be stratified 
based on BMI, race, and ethnicity. We plan to recruit approximately 31% of participants with overweight 
(BMI between 25 to 29.9 kg/m2), 42% with obesity (BMI over 30 kg/m2), and 9% with severe obesity 
(BMI over 40 kg/m2). In addition, we plan to recruit a sample that is approximately 60% white, 18% 
Hispanic or Latino, 12% Black, 5% Asian and 5% other races. The panel provider will monitor the 
stratified recruitment for the initial survey with the entire sample (n=400) and for the 150 participants 
who complete test-retest reliably and the 250 participants who will answer additional questions to 
assess construct validity. 
The food noise questionnaire will take ~5 minutes to complete. The additional questionnaires will take 
~20 minutes to complete, and this is restricted to the subsample of 250 participants who will complete 
the additional questionnaire to evaluate construct validity. Data collection consists of responding to 
multiple choice response questions.
 
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Table 1. Summary of study procedures
The Initial Surveys
400 participants will fill out:
- Demographics survey
- Food Noise Questionnaire
Time required: ~ 25 minutes
The Test-retest Reliability Sample
A random subset of 150 participants will repeat 
the Food Noise Questionnaire (8 items) about 7 
days after the first assessment (Test re-test 
reliability)
The Construct Validity Sample
A random subset of 250 participants will also 
complete questions from the following 
questionnaires (Construct validity)
For convergent validity:
- The Food Preoccupation Questionnaire- 3 items
- Food Craving Questionnaire – Trait – 6 items
For discriminant validity:
- The Patient Health Questionnaire – 8 items
- The Perceived Stress Scale – 10 items
-General Anxiety Disorder-7- 7 items
Time required: ~5 minutes
Time required: ~20 minutes
Compensation: $25
Compensation: $25
Number of Participants
The goal is to recruit no more than 400 individuals. 
Inclusion and Exclusion Criteria
Inclusion Criteria: This study is open to adults (aged 18 years and above) who reside in the United States.
Exclusion Criteria: 
●
Individuals who do not provide informed consent will not progress to the survey questions
●
Individuals who are currently participating in a weight loss program
o
Participating in a structured program (WW, Optifast, Noom Weight, etc.)
o
Using a prescription or over-the-counter medications 
o
Participating in a structured lifestyle change program (e.g., DPP).
●
Individuals who have a BMI lower than 18.5 kg/m2
Consent Process
Prior to beginning the survey, participants will receive instructions that explain the purpose of the study, 
that their participation is voluntary, and if they agree to start the survey, they are providing electronic 
consent to participate. The instructions will also alert them to the minimal required set of responses for 
all questions and their respective time commitment for each form. Specifically, 95% of items from the 
surveys must be answered to be considered complete. 
Compensation
Participation in this study is voluntary. Participants who successfully complete the surveys can receive 
$25 compensation via either a cash payout or $25 worth of points on a gift card. Successful completion 
of the surveys is defined in the survey documents. A proprietary algorithm with approximately 32 digital 
fingerprints will be used to ensure participants do not complete the survey twice and to eliminate bots 
 
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from completing surveys. Any identifiable information of the participants held by the panel provider will 
not be shared with the investigators. 
Risks and Benefits to Participants
This study involves minimal risk to participants. There is no known or anticipated risk to completing this 
self-report survey. This study confers no direct benefits for participation. 
Withdrawal of Participants
Participation involves completing online surveys in either one sitting or two sittings. The investigators do 
not have the ability to withdraw participants during survey completion.      
Data and Participant Confidentiality
All attempts will be made to maintain a participant’s privacy. Personal identifying information will be 
collected by the panel provider and kept separate from the research data.  The panel provider will 
adhere to all laws and regulations around data storage and will not share personal identifying 
information without respondents’ consent and fully complies with guidelines for online data collection 
and privacy. In addition, each participant will be assigned a participant ID. The investigators at PBRC and 
WW will have access to the participant ID and the deidentified research data. 
Sharing of Results with Participants
Individual results will not be shared with participants. Compiled results will be shared in scientific 
presentations, manuscript publications and future possible grant submissions. 
Provisions to Monitor the Data to Ensure the Safety of Participants
This study involves no greater than minimal risk to the participants; however, we will follow all standard 
procedures of clinical research at Pennington Biomedical to ensure subject privacy. 
 
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Pennington Biomedical IRB FWA 00006218
Acknowledged March 5, 2024
 

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