Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440421
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-24
Brief Title:
Understanding Food Choices in Bahrain
Sponsor:
Duke-NUS Graduate Medical School
Organization:
Duke-NUS Graduate Medical School
Study Overview
Official Title:
Evaluating Promising Food Labelling Interventions Using Bahrain e-Mart
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Using a two-arm randomized controlled trial RCT and an intercept survey the investigators aim to evaluate the effects of the Multiple-Traffic Light MTL front-of-pack FOP food labels in Bahrain on diet quality of grocery shoppers in the Kingdom of Bahrain The investigators will use an experimental online grocery store called Bahrain e-Mart which is similar in design to commercial web-based grocery stores to test these labels Participants will complete an online shopping experiment on Bahrain e-Mart such that those assigned to the control arm and those assigned to the intervention arm would be exposed to food and beverage products with no FOP labels and with MTL labels respectively
Participants will randomly be assigned to one of the following arms and asked to complete a one-time shop
Arm 1 Control Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels
Arm 2 MTL Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light MTL labels are displayed on all food and beverage products
The investigators hypothesize the following
Hypothesis 1 Diet quality as measured by weighted by the number of servings average of all purchased products Multiple Traffic Light scores for the shopping trip will be greater in Arm 2 as compared to Control Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label is assigned different colours according to whether the amount of that nutrient is low green medium amber or high red
Hypothesis 2 Diet quality as measured by weighted by the number of servings average of all purchased products Nutri-Score points for the shopping trip will be greater in Arm 2 as compared to Control Relying on the British Food Standard Agency Nutrient Profiling System the Nutri-Score NS point system assigns points to each product based on levels of 7 nutrients calories saturated fats sugar salt fibre protein and percentage of fruits vegetables and nuts per 100g or 100 ml to assess overall nutritional quality The final NS points range from 0 to 55 with 0 being the least healthy score and 55 the healthiest
Hypothesis 3 The weighted by the number of servings average calories kcal sugar g sodium mg total fat g and saturated fat g per serving will be less in Arm 2 as compared to Control
Participants will randomly be assigned to one of the following arms and asked to complete a one-time shop
Arm 1 Control Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels
Arm 2 MTL Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light MTL labels are displayed on all food and beverage products
The investigators hypothesize the following
Hypothesis 1 Diet quality as measured by weighted by the number of servings average of all purchased products Multiple Traffic Light scores for the shopping trip will be greater in Arm 2 as compared to Control Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label is assigned different colours according to whether the amount of that nutrient is low green medium amber or high red
Hypothesis 2 Diet quality as measured by weighted by the number of servings average of all purchased products Nutri-Score points for the shopping trip will be greater in Arm 2 as compared to Control Relying on the British Food Standard Agency Nutrient Profiling System the Nutri-Score NS point system assigns points to each product based on levels of 7 nutrients calories saturated fats sugar salt fibre protein and percentage of fruits vegetables and nuts per 100g or 100 ml to assess overall nutritional quality The final NS points range from 0 to 55 with 0 being the least healthy score and 55 the healthiest
Hypothesis 3 The weighted by the number of servings average calories kcal sugar g sodium mg total fat g and saturated fat g per serving will be less in Arm 2 as compared to Control
Detailed Description:
Experimental design procedures
The aim of this study is to use a 2-arm randomized controlled trial with an online grocery store Bahrain e-Mart to rigorously evaluate the effect of the Multiple Traffic Light front-of-pack MTL FOP labels displayed on all food and beverage products on diet quality
Multiple Traffic Light MTL Labels
The investigators will test one type of front-of-pack FOP label known as MTL The MTL label includes per serving size information and grades each nutrient ie energy sugar fat saturated fat and sodium separately based on recommended thresholds Green signifies a healthy amount of that nutrient red signifies an unhealthy amount and amber signifies that the nutrient levels fall between healthy and unhealthy amounts Additionally the label also shows how much of a persons daily allowance for a particular nutrient is met by consuming one serving of the product Lastly MTL includes the absolute values of each nutrient per serving of a product and the percentage of an adults daily reference intake that is met by consuming a serving of this product
Overview of Randomised Control Trial RCT Design
To test these labels the investigators used two different versions of Bahrain e-Mart Each participant was randomly assigned to one of the following arms and asked to complete a one-time shop
Arm 1 Control Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels
Arm 2 MTL Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light MTL labels are displayed on food and beverage products Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label ie sugar saturated fat fat and sodium is assigned different colours according to whether the amount of that nutrient is low green medium amber or high red
To collect shopping data as close as possible to shoppers actual grocery carts the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size Additionally participants will have to shop from at least 4 different Bahrain e-Mart categories to successfully checkout their cart Finally participants will be informed that they may win rebates ranging from 25 to 100 on their grocery order This will be done by implementing an electronic prize wheel that the participants will spin after successfully checking out their cart Every participant will have an equal chance of winning If they win any of the rebates they will be expected to conduct a grocery shop in a marketsupermarket of their choice to purchase the same items ordered on the Bahrain e-Mart grocery store website The maximum rebate they can get after spinning the wheel will be based on their drawn rebate rate and the total order amount on Bahrain e-Mart eg If participants win a 50 rebate and the total order amount on Bahrain e-Mart was BD 40 the maximum rebate they can get would be BD 20 If the exact same item cannot be found they are allowed to purchase a similar item as a replacement instead Replacements are subject to the guidelines provided in the participant information sheet and consent form that they must sign prior to enrolment and randomisation into either of the study arms
Subject related procedures
Participants will be recruited if they are Kingdom of Bahrain residents aged 21 years or older can speak and write Arabic or English and are primary weekly shoppers for their households Recruitment will be done by a market research company utilising in-person intercept surveys This survey aims to recruit participants across 4 cities and 20 locations eg shopping malls The Duke-NUS team is not directly involved in data collection
Participants will be intercepted in-person by the interviewer and be briefed about the study Those who are interested will first be invited to select their preferred language ie English or Arabic and then complete the online screener questionnaire using a tablet All eligible participants will then be asked to enter their mobile number in a textbox field and will be required to give consent for the investigators to use their personal data for registration purposes that is to verify via OTP that their mobile number has never been entered into the system before This ensures that the participant is not a duplicate participant and has not attempted to join the study before Participants who decide to withdraw from the study after screener completion and provision of their mobile number will be ineligible to participate in the study again
Participants will subsequently be asked to read an information sheet and provide their consent to enroll in this study by entering their name and email address in a textbox field Upon consent participants will be redirected to complete a baseline questionnaire to collect demographic and health characteristics which should take approximately 10 minutes to complete The baseline questionnaire includes a question as to whether any household members have a medical condition such as diabetes or hypertension which requires limiting the types of foods they eat Investigators ask this question to allow for testing whether the intervention differentially influence these households with the expectation that households with less healthy patients may obtain greater benefits from purchasing baskets with higher mean Nutri-Scores Since the objective of this RCT is to quantify the effectiveness of the intervention on diet quality a precursor to non-communicable diseases NCDs the collection of household health indicators is reasonable
Upon completion of the baseline survey participants will be randomly assigned to one of the 2 shopping conditions Arm 1 Control or Arm 2 and redirected to Bahrain e-Mart to log in and begin shopping immediately
Participants will be informed that the shop must be completed with the aim of purchasing enough groceries for all members of their household for a week If they have a household size of 8 members or less they are required to spend a minimum of BD 10 USD 26 for each member of their household and their expenditure should not exceed twice the total minimum For instance if they have 4 members their minimum expenditure should be BD 10 X 4 BD 40 and their maximum expenditure should be BD 40 x 2 BD 80 However if they have a household size of more than 8 members they are required to spend a minimum of BD 80 and a maximum of BD 160 Additionally participants must select products from at least 4 different Bahrain e-Mart Store categories eg Dairy and eggs fruits and vegetables etc
The interviewer will stand at a distance to allow participants to complete their shop privately up until the prize wheel unless the participant raises any questions The time spent completing the shop is expected to be approximately 15-20 minutes Subsequently participants will be required to complete a post-study survey which should take around 3-5 minutes to complete
Upon completion of the post-study survey participants will spin a random electronic prize wheel Depending on the results of the prize wheel their shopping trip may or may not involve actual purchases Participants may win rebates ranging from 25 to 100 based on their total order amount on Bahrain e-Mart
To claim their rebate participants are expected to email the market research company ONE image of their purchased grocery items and ONE clear image of the itemized grocery receipt for verification within 14 days from the time of study completion which is after the participant spins the prize wheel If no claims have been received via email within the stipulated time the rebate will be forfeited Please note that participants will still receive BD 25 via online transfer as stated in the participant information sheet
Once the market research company validates the two images above the study reimbursement and rebate amount will be transferred to the participant via online transfer This will be done within 24 working hours of the company receiving the images
If the prize wheel lands on BD 25 then no further action is required The study reimbursement will be transferred to the participant via online transfer immediately upon study completion The study reimbursement of BD 25 will be given to all participants regardless of the outcome of the prize wheel The prize wheel only determines the additional rebates that participants may win
All individuals who provided their consent to join this study will be emailed a copy of the full information sheet and consent form as well as the debriefing sheet when they complete the study ie after participant has spun the wheel of rebate or if they choose to withdraw from the study This is the same for participants who land on BD25 The interviewer will remind participants to review the debriefing sheet on their own
Analysis Plan
An ordinary least square model will be used to compare the primary and secondary outcome variables between the MTL arm and the control arms The model will be adjusted for potential confounders including age gender household size education level income and prevalence of diet-related health conditions that may affect the outcomes
The aim of this study is to use a 2-arm randomized controlled trial with an online grocery store Bahrain e-Mart to rigorously evaluate the effect of the Multiple Traffic Light front-of-pack MTL FOP labels displayed on all food and beverage products on diet quality
Multiple Traffic Light MTL Labels
The investigators will test one type of front-of-pack FOP label known as MTL The MTL label includes per serving size information and grades each nutrient ie energy sugar fat saturated fat and sodium separately based on recommended thresholds Green signifies a healthy amount of that nutrient red signifies an unhealthy amount and amber signifies that the nutrient levels fall between healthy and unhealthy amounts Additionally the label also shows how much of a persons daily allowance for a particular nutrient is met by consuming one serving of the product Lastly MTL includes the absolute values of each nutrient per serving of a product and the percentage of an adults daily reference intake that is met by consuming a serving of this product
Overview of Randomised Control Trial RCT Design
To test these labels the investigators used two different versions of Bahrain e-Mart Each participant was randomly assigned to one of the following arms and asked to complete a one-time shop
Arm 1 Control Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels
Arm 2 MTL Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light MTL labels are displayed on food and beverage products Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label ie sugar saturated fat fat and sodium is assigned different colours according to whether the amount of that nutrient is low green medium amber or high red
To collect shopping data as close as possible to shoppers actual grocery carts the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size Additionally participants will have to shop from at least 4 different Bahrain e-Mart categories to successfully checkout their cart Finally participants will be informed that they may win rebates ranging from 25 to 100 on their grocery order This will be done by implementing an electronic prize wheel that the participants will spin after successfully checking out their cart Every participant will have an equal chance of winning If they win any of the rebates they will be expected to conduct a grocery shop in a marketsupermarket of their choice to purchase the same items ordered on the Bahrain e-Mart grocery store website The maximum rebate they can get after spinning the wheel will be based on their drawn rebate rate and the total order amount on Bahrain e-Mart eg If participants win a 50 rebate and the total order amount on Bahrain e-Mart was BD 40 the maximum rebate they can get would be BD 20 If the exact same item cannot be found they are allowed to purchase a similar item as a replacement instead Replacements are subject to the guidelines provided in the participant information sheet and consent form that they must sign prior to enrolment and randomisation into either of the study arms
Subject related procedures
Participants will be recruited if they are Kingdom of Bahrain residents aged 21 years or older can speak and write Arabic or English and are primary weekly shoppers for their households Recruitment will be done by a market research company utilising in-person intercept surveys This survey aims to recruit participants across 4 cities and 20 locations eg shopping malls The Duke-NUS team is not directly involved in data collection
Participants will be intercepted in-person by the interviewer and be briefed about the study Those who are interested will first be invited to select their preferred language ie English or Arabic and then complete the online screener questionnaire using a tablet All eligible participants will then be asked to enter their mobile number in a textbox field and will be required to give consent for the investigators to use their personal data for registration purposes that is to verify via OTP that their mobile number has never been entered into the system before This ensures that the participant is not a duplicate participant and has not attempted to join the study before Participants who decide to withdraw from the study after screener completion and provision of their mobile number will be ineligible to participate in the study again
Participants will subsequently be asked to read an information sheet and provide their consent to enroll in this study by entering their name and email address in a textbox field Upon consent participants will be redirected to complete a baseline questionnaire to collect demographic and health characteristics which should take approximately 10 minutes to complete The baseline questionnaire includes a question as to whether any household members have a medical condition such as diabetes or hypertension which requires limiting the types of foods they eat Investigators ask this question to allow for testing whether the intervention differentially influence these households with the expectation that households with less healthy patients may obtain greater benefits from purchasing baskets with higher mean Nutri-Scores Since the objective of this RCT is to quantify the effectiveness of the intervention on diet quality a precursor to non-communicable diseases NCDs the collection of household health indicators is reasonable
Upon completion of the baseline survey participants will be randomly assigned to one of the 2 shopping conditions Arm 1 Control or Arm 2 and redirected to Bahrain e-Mart to log in and begin shopping immediately
Participants will be informed that the shop must be completed with the aim of purchasing enough groceries for all members of their household for a week If they have a household size of 8 members or less they are required to spend a minimum of BD 10 USD 26 for each member of their household and their expenditure should not exceed twice the total minimum For instance if they have 4 members their minimum expenditure should be BD 10 X 4 BD 40 and their maximum expenditure should be BD 40 x 2 BD 80 However if they have a household size of more than 8 members they are required to spend a minimum of BD 80 and a maximum of BD 160 Additionally participants must select products from at least 4 different Bahrain e-Mart Store categories eg Dairy and eggs fruits and vegetables etc
The interviewer will stand at a distance to allow participants to complete their shop privately up until the prize wheel unless the participant raises any questions The time spent completing the shop is expected to be approximately 15-20 minutes Subsequently participants will be required to complete a post-study survey which should take around 3-5 minutes to complete
Upon completion of the post-study survey participants will spin a random electronic prize wheel Depending on the results of the prize wheel their shopping trip may or may not involve actual purchases Participants may win rebates ranging from 25 to 100 based on their total order amount on Bahrain e-Mart
To claim their rebate participants are expected to email the market research company ONE image of their purchased grocery items and ONE clear image of the itemized grocery receipt for verification within 14 days from the time of study completion which is after the participant spins the prize wheel If no claims have been received via email within the stipulated time the rebate will be forfeited Please note that participants will still receive BD 25 via online transfer as stated in the participant information sheet
Once the market research company validates the two images above the study reimbursement and rebate amount will be transferred to the participant via online transfer This will be done within 24 working hours of the company receiving the images
If the prize wheel lands on BD 25 then no further action is required The study reimbursement will be transferred to the participant via online transfer immediately upon study completion The study reimbursement of BD 25 will be given to all participants regardless of the outcome of the prize wheel The prize wheel only determines the additional rebates that participants may win
All individuals who provided their consent to join this study will be emailed a copy of the full information sheet and consent form as well as the debriefing sheet when they complete the study ie after participant has spun the wheel of rebate or if they choose to withdraw from the study This is the same for participants who land on BD25 The interviewer will remind participants to review the debriefing sheet on their own
Analysis Plan
An ordinary least square model will be used to compare the primary and secondary outcome variables between the MTL arm and the control arms The model will be adjusted for potential confounders including age gender household size education level income and prevalence of diet-related health conditions that may affect the outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None