NCT07572149

Brief Summary

This study was designed as a randomized controlled trial using a Solomon four-group experimental design to evaluate the effectiveness of a food safety training program. The study was conducted among food service employees working in municipal facilities. The Solomon four-group design was used to control for potential pretest sensitization effects while assessing the true impact of the intervention. Participants were randomly assigned to four groups using a randomization method. Each group included approximately equal numbers of participants. The intervention consisted of a face-to-face food safety training program developed based on identified needs. The training content included personal hygiene, food safety principles, and safe food preparation practices. The training sessions were delivered in structured modules. Data were collected using a structured questionnaire developed based on the literature and expert opinions. The questionnaire included sections assessing participants' knowledge, attitudes, and practices related to food safety. Pre-test and post-test assessments were conducted according to the Solomon four-group design. Data collection procedures and study implementation followed standardized protocols to ensure consistency. Participants were adults aged 18 years and older, able to communicate effectively, and voluntarily agreed to participate in the study. Ethical approval was obtained prior to the study, and all participants provided informed consent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

14 days

First QC Date

March 10, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Food Safety; Food Handlers; Health Education; Knowledge, Attitudes, Practice; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Score change

    No standardized scale was used in the study. The questions in the questionnaire were developed based on expert opinions. There is no cut-off point or defined score range for the scores obtained from the questions. The questionnaire used in the study was developed by the researchers based on a literature review and consisted of five sections and 64 questions. The first section of the questionnaire (questions 1-10) included the socio-demographic characteristics of the employees; the second section (questions 11-15) included their status of receiving training on food safety; the third section (questions 16-35) assessed their knowledge about food safety; the fourth section (questions 36-45) assessed their attitudes toward food safety; and the fifth section (questions 46-64) assessed their food safety practices. For the statements in the third section, participants selected the option that best suited them from "True," "False," or "I don't know." Participants received 1 point for each que

    In the control group, the post-test was administered 8 weeks after the pre-test, while in the intervention group, the post-test was administered 8 weeks after the training was provided.

Study Arms (4)

CONTROL GROUP 1

OTHER

Pretest assessment

Other: Pretest assessment

CONTROL GROUP 2

OTHER
Other: Pretest assessment

INTERVENTION 1

EXPERIMENTAL

Food safety training program

Other: Food safety training programOther: Pretest assessment

INTERVENTION 2

EXPERIMENTAL

Food safety training program

Other: Food safety training program

Interventions

The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.

INTERVENTION 1INTERVENTION 2

The reminder effect of the pretest will be evaluated.

CONTROL GROUP 1CONTROL GROUP 2INTERVENTION 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Working in the food sector
  • Having at least basic literacy skills

You may not qualify if:

  • Refusing to participate in the study
  • Having communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Metropolitan Municipality

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BehaviorHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The Solomon four-group experimental design is an advanced research model used in experimental studies to control for the effect of pretest sensitization. It is an extended form of the traditional pretest-posttest control group design and allows researchers to determine whether the pretest itself influences participants' responses. In this design, participants are randomly assigned to four groups. The first experimental group receives a pretest, followed by the intervention and then a posttest. The second experimental group receives the intervention without a pretest and is then given a posttest. The first control group receives both a pretest and a posttest but no intervention. The second control group receives only a posttest. Comparing the results of these four groups makes it possible to distinguish the true effect of the intervention from any effects that may result from the pretest. This approach strengthens the internal validity of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

May 7, 2026

Study Start

January 1, 2023

Primary Completion

January 15, 2023

Study Completion

June 30, 2023

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Preventing shared data from influencing the responses of other participants

Locations