- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07572149
THE EFFECT OF FOOD SAFETY TRAINING ON EMPLOYEES' KNOWLEDGE, ATTITUDES, AND PRACTICES: A SOLOMON FOUR-GROUP EXPERIMENT (SOLOMON-KAP)
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Kayseri, Turecko (Türkiye)
- Kayseri Metropolitan Municipality
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being 18 years of age or older
- Working in the food sector
- Having at least basic literacy skills
Exclusion Criteria:
- Refusing to participate in the study
- Having communication difficulties
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: CONTROL GROUP 1
Pretest assessment
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The reminder effect of the pretest will be evaluated.
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Jiný: CONTROL GROUP 2
|
The reminder effect of the pretest will be evaluated.
|
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Experimentální: INTERVENTION 1
Food safety training program
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The reminder effect of the pretest will be evaluated.
The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.
|
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Experimentální: INTERVENTION 2
Food safety training program
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The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Score change
Časové okno: 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 |
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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2021/799
- SOLOMON-KAP STUDY (Jiný identifikátor: SOLOMON-KAP STUDY)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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