| CTRI Number |
CTRI/2017/04/008323 [Registered on: 10/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the Household food consumption with emphasis on Processed Foods:comparison between the families with or without history of NCDS. |
|
Scientific Title of Study
|
Household food consumption with emphasis on Processed Foods:comparison between the families with or without history of NCDS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Leena Raje |
| Designation |
Principal |
| Affiliation |
Smt M.M.P Shah Womens college of Arts and Commerce |
| Address |
Smt M.M.P Shah Womens College of Arts and Commerce, 338, R.A
Kidwai Road, Matunga, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400019
India
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9920385557 |
| Fax |
|
| Email |
rajeleena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Shweta Shekhar Mahadik |
| Designation |
Student |
| Affiliation |
Dr. B.M.N.College of home science |
| Address |
Dr. B.M.N.College of home science , 338, R.A. Kidwai Road,
Matunga (E) Mumbai- 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
8087660873 |
| Fax |
|
| Email |
gshweta93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Shweta Shekhar Mahadik |
| Designation |
Student |
| Affiliation |
Dr. B.M.N.College of home science |
| Address |
Dr. B.M.N.College of home science , 338, R.A. Kidwai Road,
Matunga (E) Mumbai- 400019
Mumbai (Suburban)
MAHARASHTRA
400019
India
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
8087660873 |
| Fax |
|
| Email |
gshweta93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.M.N. College of Home Science |
|
|
Primary Sponsor
|
| Name |
Nil |
| 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 |
| Shweta Mahadik |
Dr. B.M.N. College of Home Science |
Department of clinical nutrition and dietetics,
338, R.A. Kidwai Road,
Matunga (E) Mumbai-
400019 Mumbai
(Suburban)
MAHARASHTRA
400019 India
Mumbai (Suburban)
MAHARASHTRA |
8087660873
gshweta93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Household Food Consumption with emphasis on Processed Foods: Comparison between the families with or without history of NCD’S within Mumbai from selected wards and from different socio economic groups. |
|
| ExclusionCriteria |
| Details |
Household Food Consumption with emphasis on Processed Foods: Comparison between the families with or without history of NCD’S not staying in Mumbai from selected wards and from different socio economic groups.
Any one less than 23 years or more than 55 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is conducted to compare the consumption patterns of processed foods in families with or without history of NCDS. This is observational study that includes all the three socio-economic groups that is low, middle and high across selected wards in Mumbai city. The data will be analysed using SPSS software with help of trained statistician.
|