| CTRI Number |
CTRI/2017/03/008195 [Registered on: 23/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of diet quality with prevalence of non communicable diseases in families from 3 socio economic groups |
|
Scientific Title of Study
|
A comparative study of diet quality and prevalence of non communicable diseases in families belonging to three socio economic groups |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Madhavi Sathe |
| Designation |
Assistant Professor and Head of Department of Nutrition and Meal Management |
| 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
400 019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Akhila Vaidyanathan |
| 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, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400 019
India |
| Phone |
9930352139 |
| Fax |
|
| Email |
akhilavaidhy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Akhila Vaidyanathan |
| 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, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400 019
India |
| Phone |
9930352139 |
| Fax |
|
| Email |
akhilavaidhy@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 |
| Akhila Vaidyanathan |
Dr. B.M.N. College of Home Science |
338, R.A. Kidwai Road,
Matunga, Mumbai-400 019
Mumbai (Suburban)
MAHARASHTRA |
9930352139
akhilavaidhy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes Mellitus, Hypertension/ Heart disease |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Families staying in Mumbai and coming under the selected wards |
|
| ExclusionCriteria |
| Details |
Families not staying in Mumbai and not coming under the selected wards |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nil |
The outcome will be assessed by 31st March 2017 |
|
|
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 being conducted in order to compare diet quality and prevalence of non communicable diseases (diabetes mellitus, cardiovascular disease/hypertension) in families belonging to low,middle and high socio economic groups. This is an observational study which includes all the 3 socio economic groups across the selected wards in Mumbai city. The data will be analysed using SPSS software with the help of trained statistician.
|