Diet QualityNCT05007184
Understanding Food Choices in Saudi Arabia
A study testing Chilean Warning Labels and Nutri-Score Labels in people with Diet Quality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
Using a 3-arm randomized controlled trial, the investigators aim to rigorously evaluate the effects of two front-of-pack (FOP) food labels on diet quality. The first food label is a modified version of Chilean warning FOP label and the second food label is a modified version of French FOP label, Nutri-Score. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Quality
- What is being tested?
- Chilean Warning Labels and Nutri-Score Labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Jul 2021to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who are KSA (Kingdom of Saudi Arabia) citizens
- Age of 18 and above,
- Arabic speakers, and
- A weekly primary grocery shopper for their households can participate in this study.
Who cannot join
- People who are not KSA citizens,
- Under 18 years of age,
- Cannot speak Arabic, or
- Are not weekly primary grocery shoppers for their households cannot participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Food Policy Interventions Using NUSMart
Using a 3-arm randomized controlled trial, the investigators aim to rigorously evaluate the effects of two front-of-pack (FOP) food labels on diet quality. The first food label is a modified version of Chilean warning FOP label and the second food label is a modified version of French FOP label, Nutri-Score. The investigators used an experimental online grocery store, called NUSMart, which is similar in design to commercial web-based grocery stores to test these two FOP labels. Participants were randomly assigned to one of the following arms and asked to complete a one-time hypothetical shop.
Arm 1: Participants experienced a default version of NUSMart which replicated the traditional shopping experience of online grocery stores with no FOP labels (Control).
Read more
Arm 2: Same as Arm 1 NUSMart except that Chilean warning FOP labels were displayed on less healthy food and beverages. Products with specific nutrients (i.e. sugar, sodium, saturated fat, energy) falling outside the bounds of the thresholds defined by the Chilean warning labels were depicted with the warning labels on them.
Arm 3: Same as Arm 1 NUSMart except that Nutri-Score FOP labels along with % sugar per serving were displayed on all food and beverages. These labels score products on the basis of 7 nutrients (calories, saturated fats, sugar, salt, fibre, protein and percentage of fruits, vegetables and nuts) from A to E (best to worst). To ensure that participants understood what Nutri-Score labels mean and how they work, an introductory video was shown before shopping.
The investigators hypothesize the following:
Hypothesis 1: Diet quality, as measured by weighted average Nutri-Score point of shoppers' final baskets, will be greatest in Arm 3, followed by Arm 2, followed by Control.
Hypothesis 2: Grams of sugar per serving/ milligrams of sodium per serving/ grams of saturated fat per serving/ calories per serving will be least in Arm 2, followed by Arm 3, followed by Control.
Read the detailed description
Experimental design \& procedures
The aim of this study is to use a 3-arm randomized controlled trial with an online grocery store (NUSMart), to rigorously evaluate the effect of the two FOP labels, Chilean warning labels and Nutri-Score, on diet quality.
- Food labels The investigators tested 2 different types of food labels in this study. They are as follows:
- Chilean Warning Labels: These labels were implemented in Chile in 2016. They are shown on those less-healthy food and beverage products that don't fall within thresholds that are defined for the following nutrients: sugar, sodium, calories and saturated fats. The original labels are in Spanish but the ones that the investigators displayed were in Arabic.
- Nutri-Score Labels: These labels were implemented by the French government in 2017. They are shown on all food and beverage products and range from A to E with the corresponding colours moving from Green to Red (symbolizing best to worst). The scores and grades are calculated based on 7 different nutrients grouped into 2 categories i.e. nutrients to consume (such as fibre) and nutrients to avoid (such as sugar). The investigators modified the labels by adding % sugar per serving on the right side of the labels.
- Overview of RCT Design To test these labels, the investigators used three different versions of NUSMart. Each participant was randomly assigned to one of the following arms and asked to complete a one-time hypothetical shop. Arm 1: Control arm. Participants experienced an unmodified version of NUSMart, which replicates the traditional shopping experience of online grocery stores. Arm 2: Similar to Arm 1 except that products were labeled with Chilean warning FOP labels. Arm 3: Similar to Arm 1 except that products were labeled with NutriScore FOP labels. To minimize hypothetical shopping biases, the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size.
- Subject related procedures
As the investigators have done in prior studies, participants were recruited if they were KSA residents aged 18 years or older, could speak Arabic and were primary weekly shoppers for their households. Recruitment was done using a Saudi Arabia based web panelist.
On recruitment, they were asked to fill in a baseline questionnaire to collect demographic and health characteristics, which took approximately 10-15 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. The investigators asked this question to allow for testing whether the interventions 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 interventions on diet quality, a precursor to NCDs, the collection of household health indicators is reasonable.
Upon completion of the baseline survey, participants were randomly assigned to one of the 3 shopping conditions (Arm 1 [Control], Arm 2, or Arm 3). They logged into the NUSMart website and were asked to purchase their weekly groceries with a minimum spend per person per week (the total minimum spending value depends on the household size). Each participant therefore shopped only once during the study in one of the arms (1,2 or 3) which was randomly assigned to them.
Participants were given explicit instructions to purchase groceries for the purposes of breakfast, lunch, dinner, snacks and beverage consumption for one week keeping in mind that they would not be consuming any meals outside. The stores were set up such that participants were not allowed to check out with their cart unless they selected items from at least 4 different NUSMart categories. This ensures that participants shop as though they are shopping for their own consumption i.e. to minimize hypothetical biases.
A post-study survey was conducted after the last shop to collect participant opinions on the labels and understand their impact better.
- Conditions
- Diet Quality
- Being tested
- Chilean Warning Labels, Nutri-Score Labels
- Keywords
- front-of-pack labels, online grocery shopping, Kingdom of Saudi Arabia, Chilean warning labels, Nutri-Score labels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chilean Warning LabelsBehavioural
These labels were implemented in Chile in 2016. They are shown on those less-healthy food and beverage products that do not fall within thresholds that are defined for the following nutrients: sugar, sodium, calories and saturated fats. The original labels are in Spanish but the ones that we displayed were in Arabic.
Nutri-Score LabelsBehavioural
These labels were implemented by the French government in 2017. They are shown on all food and beverage products and range from A to E with the corresponding colours moving from Green to Red (symbolizing best to worst). The scores and grades are calculated based on 7 different nutrients grouped into 2 categories i.e. nutrients to consume (such as fibre) and nutrients to avoid (such as sugar). We modified the labels by adding % sugar per serving on the right side of the labels.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Arm 1) | No intervention | Participants will experience an unmodified version of NUSMart, which replicates the traditional shopping experience of online grocery stores. |
| Warning Label Arm (Arm 2) | Experimental | Similar to Arm 1 except that products are labeled with Chilean warning FOP labels. Receives: Behavioral: Chilean Warning Labels |
| Nutri-Score Arm (Arm 3) | Experimental | Similar to Arm 1 except that products are labeled with NutriScore FOP labels. Receives: Behavioral: Nutri-Score Labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Nutri-Score
Diet quality measured by the weighted average of all purchased products' Nutri-Score for the shopping trip. Nutri-Score is an individual dietary index based on the British Food Standard Agency Nutrient Profiling System.
Measured: After completion of data collection, an average of about 1 month
Secondary outcomes (1)
Quantity of other Nutrients
grams of sugars per serving/ milligrams of sodium per serving/ grams of saturated fat per serving/ calories per serving.
Measured: After completion of data collection, an average of about 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start7 Jul 2021
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, Public Health Authority of Saudi Arabia
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
- Investigators
- Eric A Finkelstein, PhD MHA, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007184
- Sponsor's protocol ID
- 7197919
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Food Policy Interventions Using NUSMart
- ClinicalTrials.gov ID
- NCT05007184
- Acronym / sponsor ID
- 7197919
- Conditions
- Diet Quality
- Keywords
- front-of-pack labels, online grocery shopping, Kingdom of Saudi Arabia, Chilean warning labels, Nutri-Score labels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- World Bank, Public Health Authority of Saudi Arabia
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a 3-arm randomized controlled trial, the investigators aim to rigorously evaluate the effects of two front-of-pack (FOP) food labels on diet quality. The first food label is a modified version of Chilean warning FOP label and the second food label is a modified version of French FOP label, Nutri-Score. The investigators used an experimental online grocery store, called NUSMart, which is similar in design to commercial web-based grocery stores to test these two FOP labels. Participants were randomly assigned to one of the following arms and asked to complete a one-time hypothetical shop.
Arm 1: Participants experienced a default version of NUSMart which replicated the traditional shopping experience of online grocery stores with no FOP labels (Control).
Arm 2: Same as Arm 1 NUSMart except that Chilean warning FOP labels were displayed on less healthy food and beverages. Products with specific nutrients (i.e. sugar, sodium, saturated fat, energy) falling outside the bounds of the thresholds defined by the Chilean warning labels were depicted with the warning labels on them.
Arm 3: Same as Arm 1 NUSMart except that Nutri-Score FOP labels along with % sugar per serving were displayed on all food and beverages. These labels score products on the basis of 7 nutrients (calories, saturated fats, sugar, salt, fibre, protein and percentage of fruits, vegetables and nuts) from A to E (best to worst). To ensure that participants understood what Nutri-Score labels mean and how they work, an introductory video was shown before shopping.
The investigators hypothesize the following:
Hypothesis 1: Diet quality, as measured by weighted average Nutri-Score point of shoppers' final baskets, will be greatest in Arm 3, followed by Arm 2, followed by Control.
Hypothesis 2: Grams of sugar per serving/ milligrams of sodium per serving/ grams of saturated fat per serving/ calories per serving will be least in Arm 2, followed by Arm 3, followed by Control.
Detailed description
Experimental design \& procedures
The aim of this study is to use a 3-arm randomized controlled trial with an online grocery store (NUSMart), to rigorously evaluate the effect of the two FOP labels, Chilean warning labels and Nutri-Score, on diet quality.
- Food labels The investigators tested 2 different types of food labels in this study. They are as follows:
- Chilean Warning Labels: These labels were implemented in Chile in 2016. They are shown on those less-healthy food and beverage products that don't fall within thresholds that are defined for the following nutrients: sugar, sodium, calories and saturated fats. The original labels are in Spanish but the ones that the investigators displayed were in Arabic.
- Nutri-Score Labels: These labels were implemented by the French government in 2017. They are shown on all food and beverage products and range from A to E with the corresponding colours moving from Green to Red (symbolizing best to worst). The scores and grades are calculated based on 7 different nutrients grouped into 2 categories i.e. nutrients to consume (such as fibre) and nutrients to avoid (such as sugar). The investigators modified the labels by adding % sugar per serving on the right side of the labels.
- Overview of RCT Design To test these labels, the investigators used three different versions of NUSMart. Each participant was randomly assigned to one of the following arms and asked to complete a one-time hypothetical shop. Arm 1: Control arm. Participants experienced an unmodified version of NUSMart, which replicates the traditional shopping experience of online grocery stores. Arm 2: Similar to Arm 1 except that products were labeled with Chilean warning FOP labels. Arm 3: Similar to Arm 1 except that products were labeled with NutriScore FOP labels. To minimize hypothetical shopping biases, the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size.
- Subject related procedures
As the investigators have done in prior studies, participants were recruited if they were KSA residents aged 18 years or older, could speak Arabic and were primary weekly shoppers for their households. Recruitment was done using a Saudi Arabia based web panelist.
On recruitment, they were asked to fill in a baseline questionnaire to collect demographic and health characteristics, which took approximately 10-15 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. The investigators asked this question to allow for testing whether the interventions 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 interventions on diet quality, a precursor to NCDs, the collection of household health indicators is reasonable.
Upon completion of the baseline survey, participants were randomly assigned to one of the 3 shopping conditions (Arm 1 [Control], Arm 2, or Arm 3). They logged into the NUSMart website and were asked to purchase their weekly groceries with a minimum spend per person per week (the total minimum spending value depends on the household size). Each participant therefore shopped only once during the study in one of the arms (1,2 or 3) which was randomly assigned to them.
Participants were given explicit instructions to purchase groceries for the purposes of breakfast, lunch, dinner, snacks and beverage consumption for one week keeping in mind that they would not be consuming any meals outside. The stores were set up such that participants were not allowed to check out with their cart unless they selected items from at least 4 different NUSMart categories. This ensures that participants shop as though they are shopping for their own consumption i.e. to minimize hypothetical biases.
A post-study survey was conducted after the last shop to collect participant opinions on the labels and understand their impact better.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Arm 1) | No intervention | –Participants will experience an unmodified version of NUSMart, which replicates the traditional shopping experience of online grocery stores. |
| Warning Label Arm (Arm 2) | Experimental | Behavioral: Chilean Warning LabelsSimilar to Arm 1 except that products are labeled with Chilean warning FOP labels. |
| Nutri-Score Arm (Arm 3) | Experimental | Behavioral: Nutri-Score LabelsSimilar to Arm 1 except that products are labeled with NutriScore FOP labels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People who are KSA (Kingdom of Saudi Arabia) citizens
- Age of 18 and above,
- Arabic speakers, and
- A weekly primary grocery shopper for their households can participate in this study.
Key exclusion criteria (4 listed)
- People who are not KSA citizens,
- Under 18 years of age,
- Cannot speak Arabic, or
- Are not weekly primary grocery shoppers for their households cannot participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chilean Warning LabelsThese labels were implemented in Chile in 2016. They are shown on those less-healthy food and beverage products that do not fall within thresholds that are defined for the following nutrients: sugar, sodium, calories and saturated fats. The original labels are in Spanish but the ones that we displayed were in Arabic. | Behavioural | Warning Label Arm (Arm 2) |
| Nutri-Score LabelsThese labels were implemented by the French government in 2017. They are shown on all food and beverage products and range from A to E with the corresponding colours moving from Green to Red (symbolizing best to worst). The scores and grades are calculated based on 7 different nutrients grouped into 2 categories i.e. nutrients to consume (such as fibre) and nutrients to avoid (such as sugar). We modified the labels by adding % sugar per serving on the right side of the labels. | Behavioural | Nutri-Score Arm (Arm 3) |
Primary outcome
Value of Nutri-Score
Time frame: After completion of data collection, an average of about 1 month
Diet quality measured by the weighted average of all purchased products' Nutri-Score for the shopping trip. Nutri-Score is an individual dietary index based on the British Food Standard Agency Nutrient Profiling System.
1 secondary outcome
Quantity of other Nutrients
Time frame: After completion of data collection, an average of about 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Finkelstein, PhD MHA principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chilean Warning Labels and Nutri-Score Labels in people with Diet Quality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of Nutri-Score (time frame: After completion of data collection, an average of about 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.