- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080751
Eating Behaviour and Quality of Life of Night Workers in Food and Nutrition Units
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RIO Grande DO SUL
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Porto Alegre, RIO Grande DO SUL, Brazil, 90619-900
- Pontificia Universidade Católica do Rio Grande do Sul
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
women; night workers; food service.
Exclusion Criteria:
male; pregnant; poorly or incomplete questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
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|
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Experimental: Eating Behaviors
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
through study completion, an average of 19 weeks
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|
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.
|
through study completion, an average of 19 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life and quality of life at work
Time Frame: through study completion, an average of 19 weeks
|
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.
|
through study completion, an average of 19 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ana Maria Pandolfo Feoli, Pontificia Universidade Católica do Rio Grande do Sul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 44556321.5.0000.5336
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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