Eating BehaviorNCT05080751
Eating Behaviour and Quality of Life of Night Workers in Food and Nutrition Units
A study testing Eating Behaviors in people with Eating Behavior, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Eating Behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Nov 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women; night workers; food service.
Who cannot join
- male; pregnant; poorly or incomplete questionnaires.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Catolica Do Rio Grande Do Sul
Porto Alegre, Rio Grande do Sul, 90619-900
About this study
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.
Read the 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 groups. 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:
- Body Mass Index: eutrophy, overweight, obesity and severe obesity;
- Socioeconomic class: A, B1, B2, C1, C2 and D-E.
- 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.
- Quality of Life: quality of life domains to be assessed are: physical, psychological, social relations and the environment.
- 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.
As the whole study will be done online, the risks known for participating in the research are attributed to some uncomfortables 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 uncomfortables 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.
- Conditions
- Eating Behavior
- Being tested
- Eating Behaviors
- Keywords
- Eating behaviour, Clinical trial, Occupational Groups, Food Services, Collective Feeding
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating BehaviorsBehavioural
Materials to be weekly available for intervention group, following a schedule of sessions (six in total): videos, audios, booklets, films, books and other presentations. The intervention will be based online, in a asynchronous modality. Members will self-manage activities.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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, áudios (podcasts), booklets and short films will be available weekly, following a schedule of sessions. |
| Eating Behaviors | Experimental | 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. Receives: Behavioral: Eating Behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 19 weeks
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.
Measured: through study completion, an average of 19 weeks
Secondary outcomes (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.
Measured: through study completion, an average of 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start8 Nov 2021
- Primary completion15 Dec 2021
- Study completion1 Jan 2022
Why it stopped: O estudo foi encerrado pois não foi atingido o número de participantes, de acordo com o cálculo amostral.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups: intervention and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Pandolfo Feoli, Pontificia Universidade Católica do Rio Grande do Sul
- Investigators
- Ana Maria Pandolfo Feoli, Principal investigator, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080751
- Sponsor's protocol ID
- 44556321.5.0000.5336
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviour and Quality of Life of Night Workers in Food and Nutrition Units
- ClinicalTrials.gov ID
- NCT05080751
- Acronym / sponsor ID
- 44556321.5.0000.5336
- Conditions
- Eating Behavior
- Keywords
- Eating behaviour, Clinical trial, Occupational Groups, Food Services, Collective Feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: O estudo foi encerrado pois não foi atingido o número de participantes, de acordo com o cálculo amostral.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 groups. 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:
- Body Mass Index: eutrophy, overweight, obesity and severe obesity;
- Socioeconomic class: A, B1, B2, C1, C2 and D-E.
- 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.
- Quality of Life: quality of life domains to be assessed are: physical, psychological, social relations and the environment.
- 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.
As the whole study will be done online, the risks known for participating in the research are attributed to some uncomfortables 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 uncomfortables 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups: intervention and control
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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, áudios (podcasts), booklets and short films will be available weekly, following a schedule of sessions. |
| Eating Behaviors | Experimental | Behavioral: Eating BehaviorsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women; night workers; food service.
Key exclusion criteria (1 listed)
- male; pregnant; poorly or incomplete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating BehaviorsMaterials to be weekly available for intervention group, following a schedule of sessions (six in total): videos, audios, booklets, films, books and other presentations. The intervention will be based online, in a asynchronous modality. Members will self-manage activities. | Behavioural | Eating Behaviors |
Primary outcome
Eating practices
Time frame: through study completion, an average of 19 weeks
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.
Eating behavior
Time frame: through study completion, an average of 19 weeks
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.
1 secondary outcome
Quality of life and quality of life at work
Time frame: through study completion, an average of 19 weeks
Results and safety
The study was stopped early (reason given: O estudo foi encerrado pois não foi atingido o número de participantes, de acordo com o cálculo amostral.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. no.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Maria Pandolfo Feoli principal investigator
Pontificia Universidade Católica do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating Behaviors in people with Eating Behavior, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: O estudo foi encerrado pois não foi atingido o número de participantes, de acordo com o cálculo amostral.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating practices (time frame: through study completion, an average of 19 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.