UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048759 |
|---|---|
| Receipt number | 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 15:58:39 |
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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
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
anushaonconurse@gmail.com
Sponsor or person
Institute
SHRI VINOBA BHAVE COLLEGE OF NURSING
SILVASSA
DADRA AND NAGAR HAVELI
Institute
Department
Personal name
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
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
Value
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 |
