Practice Randomized Controlled TrialSOLOMON-KAPNCT07572149
THE EFFECT OF FOOD SAFETY TRAINING ON EMPLOYEES' KNOWLEDGE, ATTITUDES, AND PRACTICES: A SOLOMON FOUR-GROUP EXPERIMENT
A study testing Food safety training program and Pretest assessment in people with Practice Randomized Controlled Trial and Solomon, run by Kayseri University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Practice Randomized Controlled Trial, Solomon, Knowledge, Attitudes, Practice
- What is being tested?
- Food safety training program and Pretest assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Jun 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Working in the food sector
- Having at least basic literacy skills
Who cannot join
- Refusing to participate in the study
- Having communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF FOOD SAFETY TRAINING ON KNOWLEDGE, ATTITUDE AND PRACTICES (KAP) OF FOOD INDUSTRY EMPLOYEES: AN EVALUATION USING THE SOLOMON FOUR-GROUP EXPERIMENTAL DESIGN
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.
Read the detailed description
Methods Study Design and Setting This study was designed as a randomized controlled trial employing a Solomon four-group experimental design to evaluate the effectiveness of a food safety training program. The study was conducted among food industry employees working in municipal social facilities. The Solomon four-group design was selected to assess the true effect of the intervention while controlling for potential pretest sensitization bias, thereby strengthening both internal and external validity.
Participants and Sample Size A total of 278 food industry employees working in municipal facilities were assessed for eligibility. Sample size calculation was performed using the Epi Info software based on an assumed food safety training prevalence of 85.9%, derived from previous studies, with a 5% margin of error and a 95% confidence interval. The minimum required sample size was calculated as 186 participants. To account for potential data loss, this number was increased by 10%, resulting in a final target sample size of 200 participants.
Eligible participants were adults aged 18 years or older, employed in the food sector, and possessing at least basic literacy skills. Individuals who declined participation or had communication barriers were excluded from the study.
Reasons for exclusion and participant flow throughout the study are presented in Figure 1.
Randomization and Group Allocation Following eligibility assessment and informed consent, 200 participants were randomly allocated into four groups using a random numbers table, with 50 participants assigned to each group. The randomization process, group allocation, intervention exposure, follow-up, and final analysis numbers are summarized in Figure 1.
- Intervention Group 1 (Pretest + Training + Posttest)
- Intervention Group 2 (Training + Posttest)
- Control Group 1 (Pretest + Posttest)
- Control Group 2 (Posttest only) The flow of participants through the study and group allocation process is illustrated in Figure 1.
Intervention Development of Training Content Baseline data obtained from Intervention Group 1 and Control Group 1 (the pretested groups) were analyzed to identify gaps in food safety knowledge, attitudes, and practices. These baseline findings were used to inform and tailor the content of the food safety training program, ensuring that the intervention addressed participants' identified needs.
Based on this needs assessment, a structured training program consisting of three modules was developed:
- Personal hygiene knowledge, attitudes, and practices
- Workplace hygiene knowledge, attitudes, and practices
- Safe food preparation processes Delivery of the Training Program The training intervention was delivered face-to-face by the research team in designated training halls within municipal facilities. The program consisted of three sessions, each comprising a 35-minute structured lecture followed by a 10-minute question-and-answer and discussion period. A 15-minute break was provided between sessions, and a maximum of 25 participants attended each session.
Participants in the intervention groups received the training program, whereas no intervention was applied to the control groups during the study period. To ensure ethical standards, control group participants were offered the same training after completion of posttest data collection.
Data Collection Instruments Data were collected using a structured questionnaire developed by the researchers based on relevant literature and expert consultation. The questionnaire comprised five sections with a total of 64 items assessing sociodemographic characteristics, previous food safety training, food safety knowledge, attitudes and practices. A pilot test was conducted with 10 food industry employees prior to data collection, and necessary revisions were made to improve clarity and relevance. The timing of pretest and posttest assessments, as well as the two-month follow-up period, are illustrated in Figure 1.
Details of the questionnaire items and scoring procedures are provided in the Supplementary Material.
- Conditions
- Practice Randomized Controlled Trial, Solomon, Knowledge, Attitudes, Practice, Health Education, Food Handlers, Food Safety
- Being tested
- Food safety training program, Pretest assessment
- Keywords
- Food Safety; Food Handlers; Health Education; Knowledge, Attitudes, Practice; Randomized Controlled Trial
- Medical subject headings
- Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food safety training programOther
The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.
Pretest assessmentOther
The reminder effect of the pretest will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP 1 | Other | Pretest assessment Receives: Other: Pretest assessment |
| CONTROL GROUP 2 | Other | Not described Receives: Other: Pretest assessment |
| INTERVENTION 1 | Experimental | Food safety training program Receives: Other: Food safety training program; Other: Pretest assessment |
| INTERVENTION 2 | Experimental | Food safety training program Receives: Other: Food safety training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jan 2023
- Primary completion15 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Practice Randomized Controlled TrialStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müncübe Duman Erbakırcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572149
- Sponsor's protocol ID
- 2021/799
- Other IDs
- SOLOMON-KAP STUDY
- Acronym
- SOLOMON-KAP
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Preventing shared data from influencing the responses of other participants
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF FOOD SAFETY TRAINING ON KNOWLEDGE, ATTITUDE AND PRACTICES (KAP) OF FOOD INDUSTRY EMPLOYEES: AN EVALUATION USING THE SOLOMON FOUR-GROUP EXPERIMENTAL DESIGN
- ClinicalTrials.gov ID
- NCT07572149
- Acronym / sponsor ID
- SOLOMON-KAP / 2021/799
- Conditions
- Practice Randomized Controlled Trial, Solomon, Knowledge, Attitudes, Practice, Health Education, Food Handlers, Food Safety
- Keywords
- Food Safety; Food Handlers; Health Education; Knowledge, Attitudes, Practice; Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kayseri UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 May 2026 (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.
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.
Detailed description
Methods Study Design and Setting This study was designed as a randomized controlled trial employing a Solomon four-group experimental design to evaluate the effectiveness of a food safety training program. The study was conducted among food industry employees working in municipal social facilities. The Solomon four-group design was selected to assess the true effect of the intervention while controlling for potential pretest sensitization bias, thereby strengthening both internal and external validity.
Participants and Sample Size A total of 278 food industry employees working in municipal facilities were assessed for eligibility. Sample size calculation was performed using the Epi Info software based on an assumed food safety training prevalence of 85.9%, derived from previous studies, with a 5% margin of error and a 95% confidence interval. The minimum required sample size was calculated as 186 participants. To account for potential data loss, this number was increased by 10%, resulting in a final target sample size of 200 participants.
Eligible participants were adults aged 18 years or older, employed in the food sector, and possessing at least basic literacy skills. Individuals who declined participation or had communication barriers were excluded from the study.
Reasons for exclusion and participant flow throughout the study are presented in Figure 1.
Randomization and Group Allocation Following eligibility assessment and informed consent, 200 participants were randomly allocated into four groups using a random numbers table, with 50 participants assigned to each group. The randomization process, group allocation, intervention exposure, follow-up, and final analysis numbers are summarized in Figure 1.
- Intervention Group 1 (Pretest + Training + Posttest)
- Intervention Group 2 (Training + Posttest)
- Control Group 1 (Pretest + Posttest)
- Control Group 2 (Posttest only) The flow of participants through the study and group allocation process is illustrated in Figure 1.
Intervention Development of Training Content Baseline data obtained from Intervention Group 1 and Control Group 1 (the pretested groups) were analyzed to identify gaps in food safety knowledge, attitudes, and practices. These baseline findings were used to inform and tailor the content of the food safety training program, ensuring that the intervention addressed participants' identified needs.
Based on this needs assessment, a structured training program consisting of three modules was developed:
- Personal hygiene knowledge, attitudes, and practices
- Workplace hygiene knowledge, attitudes, and practices
- Safe food preparation processes Delivery of the Training Program The training intervention was delivered face-to-face by the research team in designated training halls within municipal facilities. The program consisted of three sessions, each comprising a 35-minute structured lecture followed by a 10-minute question-and-answer and discussion period. A 15-minute break was provided between sessions, and a maximum of 25 participants attended each session.
Participants in the intervention groups received the training program, whereas no intervention was applied to the control groups during the study period. To ensure ethical standards, control group participants were offered the same training after completion of posttest data collection.
Data Collection Instruments Data were collected using a structured questionnaire developed by the researchers based on relevant literature and expert consultation. The questionnaire comprised five sections with a total of 64 items assessing sociodemographic characteristics, previous food safety training, food safety knowledge, attitudes and practices. A pilot test was conducted with 10 food industry employees prior to data collection, and necessary revisions were made to improve clarity and relevance. The timing of pretest and posttest assessments, as well as the two-month follow-up period, are illustrated in Figure 1.
Details of the questionnaire items and scoring procedures are provided in the Supplementary Material.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP 1 | Other | Other: Pretest assessmentPretest assessment |
| CONTROL GROUP 2 | Other | Other: Pretest assessment |
| INTERVENTION 1 | Experimental | Other: Food safety training program, Other: Pretest assessmentFood safety training program |
| INTERVENTION 2 | Experimental | Other: Food safety training programFood safety training program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Working in the food sector
- Having at least basic literacy skills
Key exclusion criteria (2 listed)
- Refusing to participate in the study
- Having communication difficulties
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 |
|---|---|---|
| Food safety training programThe interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices. | Other | INTERVENTION 1, INTERVENTION 2 |
| Pretest assessmentThe reminder effect of the pretest will be evaluated. | Other | CONTROL GROUP 1, CONTROL GROUP 2, INTERVENTION 1 |
Primary outcome
Score change
Time frame: 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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Preventing shared data from influencing the responses of other participants
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food safety training program and Pretest assessment in people with Practice Randomized Controlled Trial and Solomon, run by Kayseri University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 May 2026. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score change (time frame: 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.). 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 7 May 2026.