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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Singapore1 site
  • Duke-NUS Graduate Medical School

    Singapore, 169857

Other trials in Singapore

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.

  1. Food labels The investigators tested 2 different types of food labels in this study. They are as follows:
  2. 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.
  3. 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.
  4. 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.
  5. 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 groups in NCT05007184
Study groupRoleWhat they receive
Control Arm (Arm 1)No interventionParticipants will experience an unmodified version of NUSMart, which replicates the traditional shopping experience of online grocery stores.
Warning Label Arm (Arm 2)ExperimentalSimilar to Arm 1 except that products are labeled with Chilean warning FOP labels.
Receives: Behavioral: Chilean Warning Labels
Nutri-Score Arm (Arm 3)ExperimentalSimilar 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.

  1. 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)
  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.

  1. First posted16 Aug 2021
  2. Study start7 Jul 2021
  3. Primary completion26 Jul 2021
  4. Study completion26 Jul 2021

Resources

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)
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

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.

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