CTRI Number |
CTRI/2022/04/041946 [Registered on: 19/04/2022] Trial Registered Prospectively |
Last Modified On: |
13/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Nutrition knowledge on protein in household food decision makers of Maharashtra and Goa |
Scientific Title of Study
|
Assessment of nutrition knowledge on protein quality and requirement amongst gatekeepers of Maharashtrian and Goan community of India. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Not Applicable |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shruti Dhananjay Vaidya |
Designation |
Student |
Affiliation |
Dr BMN College of Homescience |
Address |
9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience,
Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019
Mumbai MAHARASHTRA 400019 India |
Phone |
9623891925 |
Fax |
|
Email |
miss.shru2806@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rupali Sengupta |
Designation |
Professor |
Affiliation |
Dr BMN College of Homescience |
Address |
9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience,
Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019
Mumbai MAHARASHTRA 400019 India |
Phone |
9892415789 |
Fax |
|
Email |
rupali@bmncollege.com |
|
Details of Contact Person Public Query
|
Name |
Shruti Dhananjay Vaidya |
Designation |
Student |
Affiliation |
Dr BMN College of Homescience |
Address |
9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience,
Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019
Mumbai MAHARASHTRA 400019 India |
Phone |
9623891925 |
Fax |
|
Email |
miss.shru2806@gmail.com |
|
Source of Monetary or Material Support
|
Dr BMN College of Home Science |
|
Primary Sponsor
|
Name |
Not applicable |
Address |
Not applicable |
Type of Sponsor |
Other [Not applicable] |
|
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 |
Shruti Vaidya |
Dr BMN College of Home Science |
338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019 Mumbai MAHARASHTRA |
9623891925
miss.shru2806@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SevaMandal Education Societys Institutional Ethical Committee (IEC), Matunga, Mumbai-19 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Not applicable |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Household food gatekeepers, having a decision taking capacity of food selection, preparation and purchase for entire family, belonging to Maharashtra and Goa region of India |
|
ExclusionCriteria |
Details |
below the age of 30, and above the age of 50, belonging to other states, not a food gatekeeper |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Difference may be seen in the knowledge scores, attitudes and practices between both groups, Maharashtrian and Goan community |
4 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
Not applicable |
|
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)
|
25/04/2022 |
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 Applicable |
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
|
Proteins form the building blocks of the human body. Almost the entire mechanism of the different organ systems depends on proteins. The amino acids which form the proteins help body repair cells and make new ones. Therefore, it is critically important for the growth and development in children, teens, and pregnant women. Adequate consumption of dietary protein is required for the maintenance of optimal health during normal growth and aging. Over the past two decades, the potential muscle-related benefits achieved by consuming higher-protein diets have become increasingly clear. (Wolfe, 2012) Despite greater awareness of how higher-protein diets might be advantageous for muscle mass, many have fear of consuming high protein diet, ending up in protein deficit for a long period of time. Either lack of knowledge, or misconceptions about the protein requirements, quality, functions, sources and its significance, forms a barrier from eating moderate to high protein diets which are needed to meet the daily requirements in Indian adults. This lack of information can give rise to long term protein deficiency or toxicity, and may cause long term health problems and conditions. (Ackerman 2020) The nutrition of an individual depends on the knowledge and practices followed by him/her and/or the gate keeper of the family the individual belongs to. A gatekeeper is the one who is the decision maker of the house concerning the food choice, cooking, and planning for the house. A gatekeeper could be anyone who has maximum say in the family’s food consumption pattern. Usually in Indian families, the Wife, Mother, or Daughter are identified as the gatekeepers. Hence assessing the nutrition knowledge of the gatekeepers is important to understand current nutritional scenario of the family and may help predict possible outcomes. |