| 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
|
|
|
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
|
|
|
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 varyâ€.
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 |
|
|
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. |