- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761342
Evaluating the Relative Effectiveness of Two Front-of-pack Nutrition Labels (NUSMart NM)
Multiphase Evaluation of Healthier Choice Symbol (HCS) Logo: Aim 4. A Randomized Controlled Trial Evaluating the Relative Effectiveness of Two Front-of-pack Nutrition Labels
In efforts to promote a healthy diet, the Singapore Health Promotion Board (HPB) has attempted to use Front-of-Pack (FOP) labelling to supplement traditional nutrition labelling. The Healthier Choice Symbol (HCS) identifies food items within a specific category of foods as healthier choices. The original logos were enhanced to include additional information focusing on particular macronutrients, taking one of two themes; it either indicates that a product contains more of a healthier ingredient, or less of a less healthy ingredient.
However, there is a lack of scientific evidence on the role of the existing symbols in assisting consumers make healthier food purchasing decisions. Thus far, studies have established that the United Kingdom's Multiple Traffic Lights (MTL) label, and the new French Nutri-Score (NS) label, are amongst the top performers. However, there is little consensus on which is the most effective FOP label to promote diet quality. Thus, the investigators propose to conduct the following:
Use a three arm randomized controlled trial (RCT) and an experimental fully functional web-based grocery store to test two competing approaches of front-of-pack (FOP) labelling on measures of diet quality: 1) United Kingdom's Multiple Traffic Lights label (MTL) or 2) France's Nutri-Score (NS) labelling scheme.
The investigators hypothesize that diet quality as measured by the Alternative Healthy Eating Index (AHEI-2010) (primary outcome) will be highest in the NS arm, followed by MTL, and lowest in the no logo control arm.
Study Overview
Status
Intervention / Treatment
Detailed Description
Research Aims & hypotheses:
To use a three arm randomized controlled trial (RCT), and an experimental online grocery store developed by the team, to test two competing approaches of front-of-pack (FOP) nutrition labelling on measures of diet quality: 1) Multiple Traffic Lights (MTL) and 2) Nutri-Score (NS).
All participants will experience three different shopping conditions:
- Arm 1: A control arm that mirrors a traditional web-grocery store with no HCS or other FOP labels.
- Arm 2: Similar to Arm 1, with additional MTL labels displayed on all products FOP. A 60-second introductory video briefly explaining the MTL scheme will be shown before participants shop as they are assumed not to have pre-existing knowledge of the label.
- Arm 3: Similar to Arm 2, with Nutri-Score labels instead of MTL labels displayed on all products FOP. As with the MTL, a 60-second introductory video briefly explaining the NS scheme will be shown before participants shop.
The investigators hypothesize the following:
Primary Aim: Diet quality as measured by Alternative Healthy Eating Index Scores (AHEI-2010) will be highest (best) in Arm 3, followed by Arms 2 and 1 (worst).
The investigators further hypothesize a similar ordering (Arm 3 best and Arm 1 worst) for the following secondary outcomes:
Total and per serving values of the following:
- Energy (kCal)
- Sugar (g)
- Total fat (g)
- Saturated fat (g)
- Sodium (g)
- Fiber (g)
- Protein (g) And
- Average Nutri-Score across all products purchased where A=5 and E=1, and
- Cost per calorie and per shopping trip.
The investigators will test these hypotheses in total, and separately for foods and beverages given Singapore's focus on reducing intake of sugar-sweetened beverages. The investigators will also test whether the impact of FOP labelling is moderated by mood and level of hunger at the time of purchase, and by education or income level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169857
- Duke-NUS Medical School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Singapore resident
- Aged 21 years or older.
- Existing registered RedMart customer.
Exclusion Criteria:
- Non-Singapore Resident.
- Less than 21 years old.
- Not an existing registered RedMart customer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
A control arm that mirrors a traditional web-grocery store with no but with no FOP labels.
|
|
Experimental: Multiple Traffic Light Labels
Similar to Arm 1, with Multiple Traffic Light labels displayed on all products FOP.
A 60-second introductory video briefly explaining the MTL scheme will be shown before each shop in this Arm.
|
The United Kingdom's Multiple Traffic Light label has repeatedly demonstrated effectiveness and has been widely implemented in Europe.
The label shows how much calories, fats, saturated fats, sugar and salt are present in a product, with associated traffic light signals for high (red), medium (amber) and low (green) percentages for each attribute.
|
Experimental: Nutri-Score
Similar to Arm 2, with Nutri-Score labels instead of MTL labels displayed on all products FOP.
A 60-second introductory video briefly explaining the NS scheme will be shown to shoppers in this condition.
|
In late 2017, France began voluntary implementation of one FOP label, termed Nutri-Score, adapted from its predecessor, the 5-colour Nutrition Label.
Consumer acceptability and understanding of the NS label has been demonstrated in several studies.
It provides a letter score as a composite grade of a product's nutrition quality from A (best) to E (worst).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet Quality per shopping trip
Time Frame: Once a week for three weeks
|
Diet quality per shopping trip, as measured by an index of diet quality, the Alternative Healthy Eating Index (AHEI-2010).
The Alternate Healthy Eating Index-2010 (AHEI-2010) is an updated measure of diet quality from the original Alternate Healthy Eating Index.
It was constructed based on foods and nutrients predictive of chronic disease risk that incorporates current scientific evidence on diet and health.
All AHEI-2010 components are scored from 0 (worst) to 10 (best), for a total of 11 components.
The total AHEI-2010 score ranges from 0 (nonadherence) to 110 (perfect adherence).
Higher scores on the AHEI-2010 are strongly associated with lower risk of major chronic disease as well as risk of CVD, diabetes, heart failure, colorectal and estrogen-receptor-negative breast cancer, and total and cardiovascular mortality.
|
Once a week for three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Energy in kilocalories
Time Frame: Once a week for three weeks
|
Total Energy (kCal)
|
Once a week for three weeks
|
Total Sugar in grams
Time Frame: Once a week for three weeks
|
Total Sugar (g)
|
Once a week for three weeks
|
Total fat in grams
Time Frame: Once a week for three weeks
|
Total Fat (g)
|
Once a week for three weeks
|
Saturated fat in grams
Time Frame: Once a week for three weeks
|
Saturated Fat (g)
|
Once a week for three weeks
|
Sodium in milligrams
Time Frame: Once a week for three weeks
|
Sodium (mg)
|
Once a week for three weeks
|
Fiber in grams
Time Frame: Once a week for three weeks
|
Fiber (g)
|
Once a week for three weeks
|
Protein in grams
Time Frame: Once a week for three weeks
|
Protein (g)
|
Once a week for three weeks
|
Energy per serving in kilocalories per serving
Time Frame: Once a week for three weeks
|
Energy per serving (kCal per serving)
|
Once a week for three weeks
|
Sugar per serving in grams per serving
Time Frame: Once a week for three weeks
|
Sugar per serving (g per serving)
|
Once a week for three weeks
|
Total fat per serving in grams per serving
Time Frame: Once a week for three weeks
|
Total fat per serving (g per serving)
|
Once a week for three weeks
|
Saturated fat per serving in grams per serving
Time Frame: Once a week for three weeks
|
Saturated fat per serving (g per serving)
|
Once a week for three weeks
|
Sodium per serving in milligrams per serving
Time Frame: Once a week for three weeks
|
Sodium per serving (mg per serving)
|
Once a week for three weeks
|
Fiber per serving in grams per serving
Time Frame: Once a week for three weeks
|
Fiber per serving (g per serving)
|
Once a week for three weeks
|
Protein per serving in grams per serving
Time Frame: Once a week for three weeks
|
Protein per serving (g per serving)
|
Once a week for three weeks
|
Average Nutri-Score across all products purchased
Time Frame: Once a week for three weeks
|
The Nutri-Score label was developed by the Equipe de Recherche en Epidémiologie Nutritionnelle (EREN) research team based on the British Food Standards Agency nutrient profiling system, and presents the overall nutritional quality for each food and beverage on a five-point color-coded scale from A is green (best) to E in red (worst).
Average Nutri-Score across all products purchased is recoded to a score of A=5, B=4, C=3, D=2 and E=1.
Maximum possible score is 5 (all A) and the lowest possible score is 1 (all E).
A higher score represents higher nutritional quality.
|
Once a week for three weeks
|
Cost per calorie in dollars per kilocalorie
Time Frame: Once a week for three weeks
|
Cost per calorie is calculated as total spend divided by total kilocalories ($ per kCal)
|
Once a week for three weeks
|
Total spend in dollars
Time Frame: Once a week for three weeks
|
Total spend ($)
|
Once a week for three weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUSMart NM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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