| CTRI Number |
CTRI/2022/05/042628 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
15/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Household food insecurity, Dietary Diversity Score and Food Variety Score in women. |
|
Scientific Title of Study
|
A study on the association of household food insecurity, dietary diversity score and food variety score among women in Mumbai
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Saniya Shaikh |
| Designation |
Student |
| Affiliation |
Dr. BMN college of Home science |
| Address |
303/a wing, Daffodils bldg,Raheja complex, Kalyan west.
338, Rafi Ahmed Kidwai Road, Matunga, Mumbai, Maharashtra, 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
-8655042272 |
| Fax |
|
| Email |
saniyas1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Amrita Behel |
| Designation |
Guide |
| Affiliation |
S.P.N. Doshi Womens college |
| Address |
JAG DHIR BODA VIDYA SANKUL, Camalane, Ghatkoper west, Mumbai, Maharashtra 400086.
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9892974730 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Saniya Shaikh |
| Designation |
Student |
| Affiliation |
Dr. BMN college of Home science |
| Address |
303,A wing, Daffodils bldg, Raheja complex, Kalyan west, Maharashtra, 421301
338 R A Kidwai road, Matunga Mumbai
Mumbai
MAHARASHTRA
421301
India |
| Phone |
-8655042272 |
| Fax |
|
| Email |
saniyas1112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home science, Matunga, Mumbai. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
nil
|
| Type of Sponsor |
Other [] |
|
|
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 |
| Saniya Shaikh |
Dr. BMN College of Home Science |
9th floor, MSC CND department,338 R A Kidwai road
Matunga Mumbai
Mumbai
MAHARASHTRA |
-8655042272
saniyas1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUCATION SOCIETY’S INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women above 21 years of age |
|
| ExclusionCriteria |
| Details |
Women below 21 years of age
Males |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Household food insecurity, Dietary diversity score, Food Variety score and their association will be measured. |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/05/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dietary diversity (DD) is defined as the number of various foods or food categories consumed in the previous day and is measured using Food variety score (FVS), Women’s Dietary diversity score (WDDS). Diverse foods are a good source of numerous macro and micronutrients and are the greatest way to ensure nutrient adequacy (Minja et al, 2021) (Weerasekara et al, 2020). The Household Food Insecurity Access Scale (HFIAS) is a derivation of the method used to determine the prevalence of food insecurity. It is a basic and easy-to-use tool for assessing the impact of development food assistance programs on the accessibility component of household food insecurity. The HFIAS data can be used to assess the prevalence of household food insecurity in a population, as well as the development of food insecurity over time (Coates et al, 2007)
|