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CTRI Number  CTRI/2024/05/067074 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of restaurant menu labelling on food choices of consumers in India. 
Scientific Title of Study   Effect of restaurant menu labelling on food choices and operational feasibility of menu labelling at workplace food outlets 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeyashree Kathiresan 
Designation  Scientist E 
Affiliation  ICMR-National Institute of Epidemiology 
Address  Division of Epidemiology and Biostatistics Room no. 315 R127, Second main Road, TNHB Colony, Ayapakkam

Chennai
TAMIL NADU
600077
India 
Phone  9043114998  
Fax    
Email  jshreek@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jeyashree Kathiresan 
Designation  Scientist E 
Affiliation  ICMR-National Institute of Epidemiology 
Address  Division of Epidemiology and Biostatistics Room no. 315 R127, Second main Road, TNHB Colony, Ayapakkam

Chennai
TAMIL NADU
600077
India 
Phone  9043114998  
Fax    
Email  jshreek@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jeyashree Kathiresan 
Designation  Scientist E 
Affiliation  ICMR-National Institute of Epidemiology 
Address  Division of Epidemiology and Biostatistics Room no. 315 R127, Second main Road, TNHB Colony, Ayapakkam

Chennai
TAMIL NADU
600077
India 
Phone  9043114998  
Fax    
Email  jshreek@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi 
 
Primary Sponsor  
Name  ICMR- National Institute of Epidemiology 
Address  R-127, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Chennai 600 077 India 
Type of Sponsor  Research institution 
 
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 
Dr Jeyashree Kathiresan  ICMR-National Institute of Epidemiology  Division of Epidemiology and Biostatistics Room no. 315 R127, Second main Road, TNHB Colony, Ayapakkam, Chennai - 600077
Chennai
TAMIL NADU 
9043114998

jshreek@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee ICMR-National Institute of Epidemiology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy human participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Menu labelling- Contextual guidance  The menu at the restaurant will be labeled for displaying the percentage of recommended daily allowance met by each given food item A standard statement like “An average active adult requires 2,000 kcal energy per day, however, calorie needs may vary”. Intervention will be administered on the spot with no specified duration of follow-up. Duration of administering the intervention:10 minutes 
Intervention  Menu labelling- Interpretational guidance  The menu at the restaurant will be labeled with Traffic light, colour coded stickers green and red to indicate healthy or unhealthy food, heart/apple symbol indicating healthy choice, physical activity calorie equivalent, star rating and certification logos. Intervention will be administered on the spot with no specified duration of follow-up. Duration of administering the intervention:10 minutes 
Intervention  Menu labelling- Quantitative nutrient information  Calorie labelling, kilojoule labelling, energy labelling, sodium, sugar content, and low-fat labelling The items in the restaurant menu will be labelled to reflect nutrient information as quantitative numbers Intervention will be administered on the spot with no specified duration of follow-up. Duration of administering the intervention:10 minutes 
Comparator Agent  Menu without labelling  Usual menu provided in the restaurant and workplace food outlet 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Patrons of chain restaurants with at least 10 outlets in from different geographical regions of Chennai and Hyderabad where no form of nutrition labelling is being practiced will be selected.
2) Professional, technical and semi/unskilled level workers of a selected group of Information technology companies. 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean (SD) calories ordered  One time point on administration of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Mean (SD) salt content ordered  One time point on administration of intervention 
Mean (SD) Refined sugar content ordered  One time point on administration of intervention 
Mean (SD) overall fat ordered  One time point on administration of intervention 
 
Target Sample Size   Total Sample Size="2040"
Sample Size from India="2040" 
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)   15/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Globally, 11 million deaths and 257 million DALYs are attributable to dietary risk factors. Along with increasing food availability and purchasing power, eating out behaviour also has influenced the ongoing nutrition transition in South East Asia.(Lipoeto, Geok Lin, & Angeles-Agdeppa, 2013) Eating out has been associated with less healthy food choices leading to higher energy and saturated fat intake alongside lesser micronutrient intake.(Lachat et al., 2012) Excess weight gain and adverse cardiometabolic outcomes have also been reported in those frequently eating out.(Bezerra, Curioni, & Sichieri, 2012). Enabling the consumer with nutritional information about food served in restaurants may influence their choice of foods and promote healthy eating.

Food Safety and Standards Authority of India(FSSAI) India have mandated menu labelling in restaurants since January 2022. Menu labelling includes displaying the calorific value of the food product/dish, serving size, reference information, allergen information, declaration of specific ingredients, logo indicating vegetarian or non-vegetarian. It is essential to understand the impact of menu labelling on consumer’s food choices and health to advocate for its implementation.

The two broad questions that this proposal sets out to answer are - What is the effect of nutritional value labelling of food items in restaurant menus on food choices? What is the feasibility and effect of implementing nutritional labelling of menu items in a workplace?

We propose a mixed methods study which will be carried out in three phases. Phase 1 will involve stakeholder analysis to understand the perceptions about various stakeholders in nutritional labelling at restaurants about their perceived utility, enablers and challenges. Phase 2 will involve a randomised controlled trial(RCT), to determine the effect of three types of menu labeling against no menu labeling. Adult customers exiting a restaurant will be randomized to receive one of the four types of menu of the restaurant they just exited- not labelled, labelled with quantitative nutrient information, labelled with interpretational guidance, labelled with contextual guidance. We will calculate the mean difference between the four arms in the Calorie, Salt content, Refined sugar content, Trans fat, Overall Fats and Price and the difference in the proportion choosing a healthier (operationally defined) option when presented with nutritional information/cheaper healthy food choices/ both.

Subject to the evidence from phase 2 favouring the effectiveness of nutritional labelling in promoting healthier food choices, phase 3 will be implementation research where we implement nutritional labelling of the menu served in a selected workplace canteen/ mess and document the effectiveness, the enablers and barriers in implementation.

The expected outcome of the study will be evidence on effectiveness of nutritional labelling of menus on food choices of consumers and the operational challenges in implementing the same. The study results will have relevant and valuable input for the policy for effective implementation of nutritional labelling of menus in food establishments.

 
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