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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048759
Receipt No. R000055552
Scientific Title ASSERTIVENESS ON FOOD HYGIENE AMONG THE RESIDENTS OF SILVASSA, DARA AND NAGAR HAVELI, INDIA
Date of disclosure of the study information 2022/08/30
Last modified on 2022/09/19

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Basic information
Public title ASSERTIVENESS ON FOOD HYGIENE
Acronym FOOD HYGIENE
Scientific Title ASSERTIVENESS ON FOOD HYGIENE AMONG THE RESIDENTS OF SILVASSA, DARA AND NAGAR HAVELI, INDIA
Scientific Title:Acronym ASSERTIVENESS, FOOD HYGIENE, RESIDENTS
Region
Asia(except Japan)

Condition
Condition NIL
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the assertiveness on food hygiene
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Enhancement of assertiveness on food safety practices.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Residents of SIlvassa, Dadra and Nagar Haveli, India.
2. Age between 18 years to 65 years.
3. Willing to participate in the study.
Key exclusion criteria 1. Residents dont understand English and Hindi.
2. Residents not available during data collection time.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name ANUSHA
Middle name ANIYAN
Last name THOMAS
Organization SHRI VINOBA BHAVE COLLEGE OF NURSING
Division name SILVASSA, DADRA AND NAGAR HAVELI
Zip code 396230
Address SVBCH CAMPUS, SILVASSA
TEL 919769632286
Email anushaonconurse@gmail.com

Public contact
Name of contact person
1st name ANUSHA
Middle name ANIYAN
Last name THOMAS
Organization SHRI VINOBA BHAVE COLLEGE OF NURSING
Division name SILVASSA, DADRA AND NAGAR HAVELI
Zip code 396230
Address SVBCH CAMPUS, SILVASSA
TEL 919769632286
Homepage URL https://orcid.org/my-orcid?orcid=0000-0001-5906-7849
Email anushaonconurse@gmail.com

Sponsor
Institute SHRI VINOBA BHAVE COLLEGE OF NURSING
SILVASSA
DADRA AND NAGAR HAVELI
Institute
Department

Funding Source
Organization SELF
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization SHRI VINOBA BHAVE COLLEGE OF NURSING
Address SILVASSA, DADRA AND NAGAR HAVELI
Tel 917046593297
Email krishraghav2010@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions "SHRI VINOBA BHAVE COLLEGE OF NURSING (SILVASSA)"

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 300
Results Vast Majority of the participants had Good 280(93.4%) and 20 (6.6%) of them had moderate assertiveness on Food Hygiene. None of them had poor assertiveness on Food Hygiene.
Results date posted
2022 Year 09 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 1. According to age, vast majority of the participants were 228(76%) between 20-45 years, 48(16%), 21(7%) and 3(1%) were belongs to 46-60 years, less than 19 years and 61 and above aged accordingly.
2. As per educational qualification, 164(54.6%), 94(31.4%), 39(13%) 3(1%), were undergraduates, secondary educated, postgraduates and had no formal education accordingly.
3. Most of the participants were 186(62%) female and 114(38%) of them were male.
Participant flow Forms attached
Adverse events Not Applicable
Outcome measures 1. There is an association between age and level of assertiveness
2. There is an association between education and level of assertiveness
3. There is an association between gender and level of assertiveness
Plan to share IPD Yes
IPD sharing Plan description Forms attached

Progress
Recruitment status Completed
Date of protocol fixation
2022 Year 07 Month 15 Day
Date of IRB
2022 Year 07 Month 30 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2022 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information STRUCTURED QUESTIONNAIRE ON ASSERTIVENESS OF FOOD HYGIENE IS PREPARED WITH 20 ITEMS AND DATA COLLECTION IS PROCESSED FOR ONE MONTH.

Management information
Registered date
2022 Year 08 Month 25 Day
Last modified on
2022 Year 09 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055552

Research Plan
Registered date File name
2022/09/19 Research Methodology on Food hygiene.docx

Research case data specifications
Registered date File name
2022/09/19 STRUCTURED QUESTIONNAIRE ON ASSERTIVENESS ON FOOD HYGIENE.docx

Research case data
Registered date File name
2022/09/19 master coding sheet FH.xlsx


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