Eating Behaviour and Quality of Life of Night Workers in Food and Nutrition Units
Phase: NA
Conditions: Eating Behavior
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

 
 
Protocol Registration 
 
 
 
 
EATING BEHAVIOR AND QUALITY OF LIFE OF NIGHT WORKERS IN FOOD AND NUTRITION 
UNITS 
 
 
 
 
 
 
Sponsor: 
 
Pontifical Catholic University of Rio Grande do Sul, PUCRS 
 
Information provided by (Responsible Party): 
 
Ana Maria Pandolfo Feoli, Pontifical Catholic University of Rio Grande do Sul, PUCRS 
 
Date of study approval by the Ethics and Research Committee/PUCRS: May 11, 2021. 
 
 
Study Description 
 
 
 
Brief Summary: 
 
Cognitive Behavioral Therapy (CBT) is used for a group of techniques in which there is a 
combination of a cognitive approach and a set of behavioral procedures. The basic principle of 
CBT can be described as follows: emotional and behavioral responses, as well as motivation, are 
not directly influenced by situations, but by the way in which these situations are usually 
processed. The worker is any person who has a work activity, regardless of being inserted in 
the formal or informal market. And, nightshift work, due to its wide application and demand, 
for technical, social and economic reasons is a topic of great relevance today. However, it can 
lead to health risks, both in biological and psychological functioning, among other emotional 
problems, causing greater propensity to stress, anxiety crisis and emotional tiredness. In the 
food and nutrition units, where the organization of work is strongly guided by Taylorist-Fordist 
principles, structured based on routines, technical standards and organization charts for the 
meals production, giving attention and dedication to the behaviors and habits of employees, 
become some strategies for maintaining and improving motivation for work and quality of life 
in this environment. Objective: to evaluate the effects of an intervention to change eating 

behavior on the perception of quality of life and eating habits of night workers in food and 
nutrition units. Method: This is a research project, involving a systematic review (study I) and 
a clinical trial (study II). The systematic review aim to investigate whether there is a difference 
in eating behavior between workers, the one that works during the day and the other at night. 
The second study will consist of two groups; one control and one intervention. The research 
will consist on a web-based strategies, with two evaluative moments, before and after 
intervention. To assess the eating behavior outcome, the Dutch Eating Behavior Questionnaire 
(DEBQ) will be used; for eating practices, the Self-Applicable Scale for Food Assessment will be 
included, according to the Recommendations of the Food Guide for the Brazilian Population. 
For analysis of quality of life, the WHOQOL-Bref, short version of the WHOQOL- 100 
instrument, will be used. 
 
 
 
 
Condition or disease 
Intervention/treatment 
Eating Behavior 
Behavioral: Intervention group 
 
 
Detailed Description: 
 
The clinical trial will be a blind randomized study, in order to contemplate the objectives. This 
study, which will be fully conducted online, the individuals surveyed (1: 1) will receive, or group 
intervention, with behavioral cognitive strategies to change eating behavior, or group 
intervention without the problematization proposed for the change, just working on the 
transmission of knowledge about healthy lifestyle. The study presents two evaluative 
moments (before and after the intervention), by filling out questionnaires, which will be used 
to assess the change in eating behavior. Participants, by their own adherence to the study, will 
use digital platforms for electronic questionnaires - qualtrics, and for the materials, an 
interactive electronic mural, padlet (padlet.com). The sample will consist of night workers 
employees (night and early morning shifts), only women, that work in food and nutrition units. 
The recruitment of participants will take place from the invitation sent to multiple food and 
nutrition units, in the southern region of Brazil (states of Paraná, Santa Catarina and Rio 
Grande do Sul). Workers with less than 3 months working in the unit and on the night shift will 
be excluded from the sample; as well as interns, under 18 and pregnant women. Poorly 
completed or incomplete questionnaires will be also excluded from the sample. To obtain a 
power of 80% and error α = 5%, with an estimated sample loss of 20% in a total of 2 groups, 
the minimum number for each group is 29 investigated, totaling 58 individuals. For the sample 
calculation, the program SISA (Simple Interactive Statistical Analysis) was used. A 
sociodemographic questionnaire; a health diagnosis questionnaire; a self-applicable scale for 
Food Assessment; the Dutch Eating Behavior Questionnaire (DEBQ) and the WHOQOL- Bref 
will be used in this research. Employees who accept the invitation to participate in the study 

will receive a link to answer an online questionnaire, prepared by the Qualtrics platform. This 
questionnaire will allow to evaluate the inclusion criteria for the research. For those who not 
gets to participate in the study, will be invited to visit, through the indication of the website 
and social networks of the research group (@pevspucrs), the educational materials, such as e- 
books and planners. Those employees to be included will receive a welcome message to the 
study, and at the same time, read and sign the Informed Consent Form (ICF), which will also 
be available online. Reaching the required sample size, the groups will be randomized. 
 
Randomization will be per cluster (will be performed according to the workplaces of the 
employees to be included in the study). This type of randomization strengthens the blinding 
of research. The locations (food units) will be randomized using the Random Allocation 
Software, version 2.0 in two groups: Control Group (CG) and Intervention Group (IG).The first 
task for both groups, before the intervention, will be to complete those questionnaires: 
sociodemographic questionnaire; anamnesis with anthropometric information; the Self- 
Applicable Scale for the Assessment of Food, according to the Recommendations of the Food 
Guide for the Brazilian Population; the Dutch Questionnaire to assess Eating Behavior and the 
WHOQOL-Bref, to assess quality of life. 
 
As soon as everyone is completely filled in, the intervention process will begin. The online 
intervention it will be in asynchronous modality way. Members will self-manage activities. 
Materials for the sessions, such as videos, presentations (canva, mentimeter), infographics and 
icons, for sending tasks, will be available on an electronic wall (padlet). 
 
The intervention program materials will be available every week, during all the six (06) sessions 
for each group. At the end of the intervention, one week after the last session, the participants 
completed those questionnaires again. And after three months, from the second stage of filling 
in the instruments, the employees will answer the questionnaires again, in order to verify 
whether the effect of the intervention has been maintained. Data will be entered in the MS 
Excel application. The database will be imported into the statistical software Statistical Package 
for the Social Sciences (SPSS) IBM version 22. 
 
Variables, for the purposes of statistical analysis, will be the following: 
 
a. Body Mass Index: eutrophy, overweight, obesity and severe obesity; 
b. Socioeconomic class: A, B1, B2, C1, C2 and D-E. 
c. Self-Applicable Scale for the Assessment of Food, according to the Recommendations of the 
Food Guide for the Brazilian Population: dimensions, such as the choice of food, ways of 
eating, domestic organization and planning. 
d. Quality of Life: quality of life domains to be assessed are: physical, psychological, social 
relations and the environment. 

e. Eating Behavior: domains through the DEBQ questionnaire to be evaluated are: restricted 
food, emotional food and external food. 
 
Primary outcome: eating behavior, which will be assessed through the Dutch Questionnaire 
for the Assessment of Eating Behavior (DEBQ) and the assessment of eating practices, by the 
Self-Applicable Scale for Food Assessment, according to the Recommendations of the Food 
Guide for the Brazilian Population. 
 
Secondary outcome: quality of life. 
 
For the ethical aspects of the research, this study has already been submitted and approved 
by 
the 
PUCRS 
research 
ethics 
committee, 
under 
the 
registration 
number 
44556321.5.0000.5336, in May 11, 2021. 
 
As the whole study will be done online, the risks known for participating in the research are 
attributed to some uncomfortable moments, like answering the various questionnaires, or due 
to the time dedicated for the questions, and also due to participate in some activity, such as the 
delivery of a task. If the participant does not feel comfortable during the intervention, will be 
possible to stop participating at any time during the research. In addition of uncomfortable 
moments, it is possible that the internet connections fail or show a certain slowness, or that 
the participant will have doubts on how to save their answers. In the IC, there will be guidance 
on how to proceed in these cases. The possible benefits of participating in the research can be 
the diagnosis of the nutritional status, that will be delivered individually, and the probable 
benefits already indicated in the scientific literature by the change in eating behavior. 
 
Study Design 
 
 
Study Type: 
Interventional 
Estimated Enrollment: 
58 participants 
Allocation: 
Randomized 
Intervention Model: 
Parallel Assignment 
two groups: intervention and control 
Masking: 
Single (Participant) 
participants will not know whether they will be 
in the control or intervention group. 
Primary Purpose: 
Treatment 

Official Title: 
EATING BEHAVIOR AND QUALITY OF LIFE OF 
NIGHT WORKERS IN FOOD AND NUTRITION 
UNITS 
Estimated Study Start Date: 
October 15, 2021 
Estimated Primary Completion Date: December 15, 2021 
Estimated Study Completion Date: 
June 1, 2022 
 
 
 
Arms and Interventions 
 
Arm 
Intervention/treatment 
No Intervention: Control group 
In this modality of intervention, the focus 
will be on the development of skills through 
educational actions in health, using the 
pedagogy of transmission. The focus will be 
based on content related to food, nutrition 
and quality of life. Materials like videos, 
podcasts, booklets and short films will be 
available weekly, following a 
schedule of sessions. 
Experimental: Intervention 
In the intervention group, the focus will be 
the development of skills through educational 
health actions that provide the development 
of autonomy and empowerment for behavior 
change, based on cognitive behavioral 
interventions, which involve eating behavior 
and impact on quality of life. Cognitive 
behavioral therapy (CBT) is based on ten 
principles that influence and / or determine 
treatment attitude and approach. 
Intervention group sessions will be 
based on principles. 
Behavioral: Intervention group 
Materials to be weekly available for 
intervention group, following a schedule of 
sessions (six in total): videos, podcasts, 
booklets, 
films, 
books 
and 
other 
presentations. The intervention will be 
based online, in a asynchronous modality. 
Members will self-manage activities. 
 
Outcome Measures 
 
 
Primary Outcome Measure: 

1.Eating practices 
It will be evaluated through the assessment of eating practices, by the Self-Applicable Scale for the 
Assessment of Food, according to the Recommendations of the Food Guide for the Brazilian Population. 
Diet rating scale according to the Food Guide for the Brazilian Population: minimum value: from 0 to 31 
points; maximum value: above 41 points. 
High score means better result. 
[Time Frame: through study completion, an average of 19 weeks] 
 
2.Eating behavior 
It will be evaluated through the Dutch Questionnaire for the Assessment of Eating Behavior (DUTCH): 
emotional eating, external eating and restricted eating. Dutch Eating Behavior Questionnaire: maximum 
possible score is 33 points; the higher the score, the lower the ability to control eating; and the lower 
the score, the higher the capacity. 
[Time Frame: through study completion, an average of 19 weeks] 
Secondary Outcome Measures: 
1. Quality of life and quality of life at work 
It will be evaluated through the World Health Organization Quality Of Life - Bref. World 
Health Organization Quality of Life - bref. Results in % from 0 to 100. The higher the 
percentage (closer to 100%) the better the quality of life. 
[Time Frame: through study completion, an average of 19 weeks] 
 
 
Eligibility Criteria 
 
 
Ages Eligible for Study: 
18 Years and older 
Sexes Eligible for Study: 
Female 
Gender Based: 
Gender Eligibility Description: female only 
Accepts Healthy Volunteers: 
 
Criteria 
 
Inclusion Criteria: women, night workers in food services; in the southern region of Brazil (Paraná, 
Santa Catarina and Rio Grande do Sul).  
 
Exclusion Criteria: male, workers with less than 3 months of experience in food services; as well 
as interns, under 

18 and pregnants will be excluded. Poorly completed or incomplete questionnaires will  be 
excluded from the sample. 
 
More Information 
 
 
Responsible Party: 
Ana Maria Pandolfo Feoli, Professor, Pontifical Catholic 
University of Rio Grande do Sul, PUCRS 
ClinicalTrials.gov Identifier: 
Other Study ID Numbers: 
44556321.5.0000.5336 
Last Verified: 
May 2021 
Individual Participant Data (IPD) Sharing Statement: 
Plan to Share IPD: 
Plan Description: 
 
 
 
Human Subjects Protection Review Board Status: Approved 
Studies a U.S. FDA-regulated Drug Product: No 
Studies a U.S. FDA-regulated Device Product: No 

 
Statistical Analysis 
 
 
 
 
Initially, the data will be entered into the MS Excel application. Afterwards, the database 
will be imported into the Statistical Package for Social Sciences (SPSS) IBM version 22 
statistical program. 
Variables 
The variables used for statistical analysis purposes will be as follows: 
a) Body Mass Index: eutrophy, overweight, obesity and severe obesity; 
b) Socioeconomic class: A, B1, B2, C1, C2 and D-E. 
c) Self-applicable Scale for Food Assessment, according to the Recommendations of the 
Food Guide for the Brazilian Population: dimensions such as food choice, eating habits, 
household organization and planning. 
d) Quality of Life: quality of life domains to be evaluated are: physical, psychological, 
social relationships and the environment. 
e) Eating Behavior: the domains of the AC by the use of the Dutch questionnaire to be 
evaluated are: restricted eating, emotional eating and external eating. 

INFORMED CONSENT FORM (ICF) FOR ONLINE STUDIES 
 
"EATING BEHAVIOR AND QUALITY OF LIFE OF NIGHT WORKERS IN FOOD AND 
NUTRITIONUNITS" 
 
Please read the following text about the study. If you feel like participating in the 
research, express your consent by selecting the option “I have read and agree to 
participate in the research” presented at the end of this term. As it is a ICF on a web 
page, and without the possibility of physical signature, after the consent after the 
information, the message will appear “By clicking on the button below, you agree to 
participate in the survey under the terms of this ICF. If you do not agree to participate, 
just close this page in your browser”. 
Please, if you have any questions before, during or after your participation, send an email 
to the main researcher of the study: Profa Ana Feoli, cell: (51) 999113014, email: 
anafeoli@pucrs.br. If you have any questions about your rights as a research participant, 
please contact the Research Ethics Committee of the Pontifical Catholic University of Rio 
Grande do Sul (CEP-PUCRS), located at Ipiranga avenue, 6681/building 50, room 703, ZIP 
Code: 90619-900, Partenon, Porto Alegre/RS, e-mail: cep@pucrs.br, Monday to Friday 
from 8:00 am to 12:00 pm and from 1:30 pm to 5:00 pm. The Ethics Committee is an 
independent agency made up of professionals from different areas of knowledge and 
members of the community. Its responsibility is to ensure the protection of the rights, 
safety and well-being of participants through review and approval of the study, among 
other actions. 
 
CONSENT TO PARTICIPATE IN THE RESEARCH 
You are being invited to participate in a survey developed by Luísa Rihl Castro called 
“Eating Behavior and Quality of Life of Night Workers in Food and Nutrition Units” of the 
Graduate Program in Psychology at PUCRS. The objective is to evaluate the effects of a 
(nutritional) intervention to change eating behavior in the perception of quality of life 
and eating habits of night workers in food and nutrition units. Please read the 
information below and, if you do not understand or have any further questions, you can 
contact us by e-mail luisa.castro@pucrs.br, before deciding whether or not to 
participate. This survey is voluntary, and you have the right not to respond to any item 
and also to discontinue your participation at any time for any reason. The study predicts 
their participation over seven (07) weeks, occupying around 2 days a week (more or less, 
one hour each day). The research will be conducted completely online, through the use 
of questionnaires and access to a platform, with interactive content on health and 
nutrition. Through a link to be shared, you will have access to the materials. The known 
risks of participating in this research model (online) are attributed to small discomforts 
in answering the questionnaires, due to the time to be devoted to the questions, and 
also to the delivery(online) of the activities. The survey will be divided into weekly 
sessions, with the completion and delivery of tasks. In addition to the discomfort, you 
may feel as a result of the responses to these questionnaires, it is possible that, 
unfortunately, your connection may fail or show some slowdown, or that you may have 
doubts about how to save your answers. Your survey will be saved automatically, don't 

worry, OR you need to click “save” to properly collect your answers. In these cases, do not 
hesitate to contact the researcher, Profa Ana Feoli, cell phone: (51) 999113014, or email: 
anafeoli@pucrs.br; or with Luísa Rihl Castro, by e-mail luisa.castro@pucrs.br. The 
benefits arising from their participation in the research include the diagnosis of 
nutritional status (which will be delivered individually) and the likely benefits already 
indicated in the scientific literature by the change in eating behavior. The study is free 
and voluntarily and there will also be no form of reward (payment). No identifying 
information about you will be included in publications that may result from this search. 
The collection of information for this project will be completed between July and August 
2021 and all information obtained will be securely stored for a period of five (05) years 
after this date, or until completion of the written work. By continuing this survey, you 
agree that any questions you had have been adequately answered and that you agree 
to participate in this study. I understand the procedures described above, and: 
( ) I agree and agree to participate in the survey 
( ) I do not agree and do not agree to participate in the survey