NCT05080751

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

July 6, 2021

Last Update Submit

April 13, 2023

Conditions

Keywords

Eating behaviourClinical trialOccupational GroupsFood ServicesCollective Feeding

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 19 weeks

Secondary Outcomes (1)

  • Quality of life and quality of life at work

    through study completion, an average of 19 weeks

Study Arms (2)

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.

Behavioral: Eating Behaviors

Interventions

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.

Eating Behaviors

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women; night workers; food service.

You may not qualify if:

  • male; pregnant; poorly or incomplete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifícia Universidade Catolica Do Rio Grande Do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Ana Maria Pandolfo Feoli

    Pontificia Universidade Católica do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will not know whether they will be in the control or intervention group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups: intervention and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2021

First Posted

October 18, 2021

Study Start

November 8, 2021

Primary Completion

December 15, 2021

Study Completion

January 1, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

no.

Locations