| CTRI Number |
CTRI/2022/11/047523 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
developing dietary assessment tool |
| Study Design |
Other |
|
Public Title of Study
|
Developing accurate questionnaire to measure diet quality of Indians |
|
Scientific Title of Study
|
Development and validation of Dietary assessment Index for Indians |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshina Banjade |
| Designation |
Student |
| Affiliation |
Welcomegroup Graduate School of Hotel Administration |
| Address |
Welcomgroup Graduate School of Hotel Administration, Madhavnagar,Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7622052628 |
| Fax |
|
| Email |
roshina.banjade@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Mahesh Shettigar |
| Designation |
Co-ordinator |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Welcomgroup Graduate School of Hotel Administration, Madhavnagar,Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
|
| Email |
pallavi.wgsha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Mahesh Shettigar |
| Designation |
Co-ordinator |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Welcomgroup Graduate School of Hotel Administration, Madhavnagar,Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
|
| Email |
pallavi.wgsha@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Roshina Banjade, Chinthana C., Tagaram. Priscilla Abigail |
| Address |
Mnaipal, Udupi |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Roshina Banjade |
Welcomgroup Graduate School of Hotel Administration |
Room No. 20, First Floor, Department of Dietetics and Applied Nutrition
Udupi
KARNATAKA |
7622052628
roshina.banjade@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
| The Institutional research Committee WGSHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
General Population |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People from the age group of 18-60 years |
|
| ExclusionCriteria |
| Details |
Pregnant/ Lactating Women, Critically ill people, People who are under calorie
restriction, and People with the comorbid condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of dietary assessment tool |
once |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="576"
Sample Size from India="576"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dietary Assessment is essential to assess the diet quality of the individual pertaining to all the factors like adequacy, variety, and nutrient requirements. however, the lack of such a tool has restricted the ability to assess the Indian population’s dietary intake. thus, through this study, the development and validation of a dietary assessment index for Indians are formed to assess their diet quality and pattern. components involved in the index are adequacy, variety, moderation, and balance, through the help of dietary assessment methods like FFQ and 24-hour recall, dietary data is collected, analyzed, and scored using the dietary assessment index for Indians. |