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CTRI Number  CTRI/2020/11/029008 [Registered on: 10/11/2020] Trial Registered Prospectively
Last Modified On: 09/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the overall impact of consumption of non-alcoholic beverages on working from home adults, pre and during COVID times  
Scientific Title of Study   Association between consumption of non-alcoholic beverages (pre and during COVID times) and nutritional status, stress levels and work performance of working from home adults 25-45 years 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Majumdar 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration, MAHE 
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9748036033  
Fax    
Email  shreya.majumdar@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenakshi Garg 
Designation  Associate Professor, Department of Dietetics and Applied Nutrition 
Affiliation  Welcomgroup Graduate School of Hotel Administration,MAHE 
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration

Udupi
KARNATAKA
576104
India 
Phone  9343163237  
Fax    
Email  meenakshi.garg@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dalia V R 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration, MAHE 
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8921332944  
Fax    
Email  dalia.r11@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, Welcomgroup Graduate School of Hotel Aministration, MAHE, Manipal, Udupi, Karnataka-576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shreya Majumdar  Manipal Campus  Welcomgroup Graduate School of Hotel Administration, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA 		 9748036033

shreya.majumdar@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  none 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Working from home adults willing to participate 
 
ExclusionCriteria 
Details  1.Adults with chronic disorders/medical condition/co-morbidities such as diabetes,
high blood pressure and heart related conditions.
2.Adults with compromised immune system and critical medical conditions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the association between the consumption of non-alcoholic beverages and nutritional status, stress levels and work performance from home working adults(25-45 years  December 2020 
 
Secondary Outcome  
Outcome  TimePoints 
To study the comparison between consumption of non-alcoholic beverages in pre COVID
and during COVID times of working from home adults (25-45 years) 		 December 2020 
 
Target Sample Size   Total Sample Size="295"
Sample Size from India="295" 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Non-alcoholic drinks which include- carbonated soft drinks, packaged fruit juices, energy drinks, tea, coffee, bottled flavoured and tonic water, squashes, syrups and milk based drinks such as malted drinks and milkshakes are being frequently consumed by adults which are leading to various health complications. Nowadays, there are various choices for consumers among non-alcoholic beverages and a trend of increased consumption of soft drinks and decreased consumption of milk has been seen. Obesity is the most common nutrition related health issue which is being observed in adults today. The consumption of stimulants like tea and coffee are on an increase. According to the 2010 Dietary Guidelines for Americans, ”SSB’s are liquids that are sweetened with various forms of sugars that add calories. These beverages include, but are not limited to, soda and fruit drinks, and sports and energy drinks.” Research has been done worldwide to study the effect of consumption of junk food and sugary drinks on the risk of obesity. Free sugars from SSB’s have been linked to obesity. SSB’s and stimulants like tea and coffee has also been associated with stress and mental health. Consumption of non-alcoholic beverages is on a rise. The beverage choice of an individual has shown to have an important impact on the nutritional quality, intake of calories and intake of other nutrients and minerals. The dietary pattern of working adults usually consists of plenty of fast foods and sugary drinks which are easily available and convenient and less nutritious foods, fruit and vegetable intake, which may lead to various health complications and comorbidities. During stressful situations, the consumption pattern of stimulants, sugary drinks and junk foods increases. Since the COVID pandemic has began, lots of changes in dietary patterns, lifestyle changes and physical activity has been seen. Both healthy and unhealthy eating patterns have been seen. Easy accessibility and food availability has changed and due to lockdown, physical activity has reduced. Working from home has also affected the mental health of the people. Hence, this research will help in studying the association between consumption of non-alcoholic beverages (pre and during COVID times) and nutritional status, stress levels and work performance of working from home adults 25-45 years.  
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