| CTRI Number |
CTRI/2020/11/029041 [Registered on: 11/11/2020] Trial Registered Prospectively |
| Last Modified On: |
10/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the overall dietary practices among young and middle-aged adults pre and during COVID times |
|
Scientific Title of Study
|
Use of Food Consumption Score and Dietary Diversity Score as indicators to compare the nutritional status, dietary diversity, and potential risk of micro-nutrient deficiencies among young and middle-aged adults, pre and during COVID times |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeepti Pramod Nayak |
| Designation |
PG student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8073404968 |
| Fax |
|
| Email |
sudeepti.nayak@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Garg |
| Designation |
Associate Professor and HOD M.Sc Dietetics and Applied Nutrition |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9343163237 |
| Fax |
|
| Email |
meenakshi.garg@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kritthika Gonella |
| Designation |
PG student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9989642298 |
| Fax |
|
| Email |
gonella.kritthika@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Welcomgroup Graduate School of Hotel Administration, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Garg |
| Address |
Associate Professor and HOD M.Sc Dietetics and Applied Nutrition, Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka
576104 |
| 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 |
| Sudeepti Nayak |
Manipal Campus |
Welcomgroup Graduate School of Hotel Administration, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA |
8073404968
sudeepti.nayak@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Young and middle aged adults |
|
| ExclusionCriteria |
| Details |
1. Adults who are bedridden and/or are undergoing hospital treatment for any severe comorbidities
2. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of COVID-19 pandemic on the Dietary Diversity Scores and household food security among young and middle-aged adults |
December 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess the consumption and knowledge, attitude and practices with respect to immune boosting foods before and during the confinement for the COVID-19 pandemic.
|
December 2020 |
|
|
Target Sample Size
|
Total Sample Size="317"
Sample Size from India="317"
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)
|
20/11/2020 |
| 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)
|
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
|
Poor food choices involving
low diversity among food groups pose a threat to the overall health of a
person. Adults are favoring energy-dense foods more due to palatability and
cost-effectiveness, but in the process, are raising the likelihood of
development of metabolic disorders, while also consuming insufficient
micronutrients and thus increasing the risk of developing deficiencies. The
possibility that the COVID-19 pandemic has affected these preferences will be probed into in this study. The Dietary Diversity Score is an effective
means of determining these changes in consumption patterns, and the Food
Consumption Score will provide more detail regarding these changes. Additionally, any changes in the consumption of common immune-boosting foods
such as citrus fruits and spices owing to the pandemic will also be assessed. A pre-validated semi-structured online questionnaire to collect
information regarding personal history, socio-demographic status, basic medical
history, food consumption patterns, and knowledge, attitude, and practices
related to immune-boosting foods will be sent to the participants using various social media platforms.
|