- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172337
Testing the Effects of Singapore's Front-of-Pack Healthier Choice Symbol Label With or Without a Physical Activity Equivalent Label
A Randomized Controlled Trial Testing the Effects of Singapore's Front-of-Pack Healthier Choice Symbol Label With or Without a Physical Activity Equivalent Label on Food Purchases and Measures of Diet Quality
Poor diets are known risk factors for chronic diseases, and in recent years, food labelling has been increasingly sought-after as a cost-effective intervention to help stem the rising trend in chronic diseases.
In efforts to promote a healthy diet, the Singapore Health Promotion Board (HPB) supplements traditional nutrition labelling with the Healthier Choice Symbol (HCS), which 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, to date, no published studies have assessed the role of the original and enhanced HCS logos in influencing food choices. There is a lack of scientific evidence on the role of the existing symbols in assisting consumers make healthier food purchasing decisions. There are also concerns over the unintended consequences of health claims made based on a single aspect of nutrient content, without considering other aspects. That is the goal of this effort. Specifically, 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 assess the causal effect of the new HCS logos on measures of diet quality either alone, or in combination with a complementary front-of-package (FOP) label: Physical Activity Equivalents (PAEs), which provides information on how long one would need to engage in a certain activity (e.g., jogging) to burn off one serving of the product.
The investigators hypothesize that the greatest reduction in calories per serving (primary outcome) will occur in the HCS plus PAEs arm, followed by HCS only, and no logo control arm.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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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 residents
- 21 years of age and above
- Primary grocery shopper for the household
Exclusion Criteria:
- Not residing in Singapore
- Under 21 years of age
- Not the primary grocery shopper for the household
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: No labeling Control
Arm 1 was the Control condition, which did not display FOP labels on any products.
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EXPERIMENTAL: HCS-only
Arm 2 (termed HCS-only) displayed the HCS on eligible products, crossed referenced via the Health Promotion Board's HCS database (https://www.hpb.gov.sg/food-beverage/healthier-choice-symbol).
Out of the 4,177 products available on NUSMart, 311 (7·45%) carried the HCS.
This was comprised of 150 foods and 161 beverages.
|
The HCS is intended to improve diet quality by signaling to consumers which products are healthier options within a specific category (e.g., which are the healthier biscuits or the healthier beverages).
Manufacturers must meet category-specific criteria before a product can display the HCS and an associated tagline.
The labels were displayed at the bottom of the product images.
|
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EXPERIMENTAL: HCS+PAE
Arm 3 displayed the HCS on eligible products as in Arm 2 and the PAE label on all products (termed HCS+PAE).
PAE was calculated as the minutes required to burn off the calories of a single serving for a 73 kg person jogging at 8 km per hour.
|
The HCS is intended to improve diet quality by signaling to consumers which products are healthier options within a specific category (e.g., which are the healthier biscuits or the healthier beverages).
Manufacturers must meet category-specific criteria before a product can display the HCS and an associated tagline.
The labels were displayed at the bottom of the product images.
For the study, we designed a simple PAE logo (Appendix Figure A1) and added a description encoded into the NUSMart user interface to ensure that participants would understand the contents of the label. Participants saw the following description whenever their cursor hovered over the PAE label: "The Physical Activity Equivalent (PAE) refers to the number of minutes that a typical adult would need to jog to burn off the calories associated with one serving of the product." Previous studies have shown this labelling approach to be effective. The labels were displayed at the bottom of the product images. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in average calories per serving purchased per shopping trip
Time Frame: Once a week for three weeks
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Calories per serving (kCal per serving) is calculated by dividing the total number of calories purchased in the shopping trip by the total number of servings purchased.
The average calories per serving purchased (kcal per serving) is based on mean standardized serving sizes within each subcategory.
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Once a week for three weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of HCS labelled products purchased (or would have been if not in control arm) per shopping trip
Time Frame: Once a week for three weeks
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Calories per Shopping Trip will be calculated as the sum of all purchased products' total calories.
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Once a week for three weeks
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Total Calories per shopping trip
Time Frame: Once a week for three weeks
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Total calories purchased in kcal.
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Once a week for three weeks
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Diet quality per shopping trip as measured by the Grocery Purchase Quality Index-2016
Time Frame: Once a week for three weeks
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Diet quality per shopping trip as measured by the Grocery Purchase Quality Index-2016 (GPQI-2016).
The Grocery Purchase Quality Index-2016 (GPQI-2016) contains 11 different food components with eight components scored based on adequacy and three moderation components.
We followed the standard GPQI-2016 scoring methods by mapping NUSMart's subcategories to USDA food plan categories and then to the GPQI components.
Each component was scored based on the deviation of the observed expenditure share of each component and the expected expenditure share, and the scores were totaled up to generate the final GPQI-2016 score (minimum possible score = 0, maximum possible score = 75) for each participant's weekly grocery order.
A higher score indicates better diet quality of the grocery basket.
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Once a week for three weeks
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Diet quality per shopping trip as measured by weighted average Nutri-Score
Time Frame: Once a week for three weeks
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We applied the standard Nutri-Score algorithm to assign a grade to each product.
This algorithm assigns a score of A to E based on nutritional quality, which we recoded to 5 to 1 and then calculated an average score for each participant's weekly grocery order (minimum possible score = 0, maximum possible score = 5), weighted by the number of servings of each product.
A higher score indicates better diet quality of the grocery basket.
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Once a week for three weeks
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Sugar per serving per shopping trip
Time Frame: Once a week for three weeks
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Amount of sugar (g) per serving purchased based on mean standardized serving sizes within each subcategory.
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Once a week for three weeks
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Sodium per serving per shopping trip
Time Frame: Once a week for three weeks
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Amount of sodium (mg) per serving purchased based on mean standardized serving sizes within each subcategory.
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Once a week for three weeks
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Saturated fat per serving per shopping trip
Time Frame: Once a week for three weeks
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Amount of saturated fat (g) per serving purchased based on mean standardized serving sizes within each subcategory.
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Once a week for three weeks
|
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Calories per dollar spent per shopping trip
Time Frame: Once a week for three weeks
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Number of calories per dollar (kcal per dollar) spent
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Once a week for three weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
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
Keywords
Other Study ID Numbers
- NMRC-HSRG-0060-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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