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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172337
Other study ID # NMRC-HSRG-0060-2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date April 30, 2019

Study information

Verified date November 2019
Source Duke-NUS Graduate Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthier Choice Symbol
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.
Physical Activity Equivalent label
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.

Locations

Country Name City State
Singapore Duke-NUS Medical School Singapore

Sponsors (2)

Lead Sponsor Collaborator
Duke-NUS Graduate Medical School National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in average calories per serving purchased per shopping trip 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. Once a week for three weeks
Secondary Proportion of HCS labelled products purchased (or would have been if not in control arm) per shopping trip Calories per Shopping Trip will be calculated as the sum of all purchased products' total calories. Once a week for three weeks
Secondary Total Calories per shopping trip Total calories purchased in kcal. Once a week for three weeks
Secondary Diet quality per shopping trip as measured by the Grocery Purchase Quality Index-2016 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. Once a week for three weeks
Secondary Diet quality per shopping trip as measured by weighted average Nutri-Score 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. Once a week for three weeks
Secondary Sugar per serving per shopping trip Amount of sugar (g) per serving purchased based on mean standardized serving sizes within each subcategory. Once a week for three weeks
Secondary Sodium per serving per shopping trip Amount of sodium (mg) per serving purchased based on mean standardized serving sizes within each subcategory. Once a week for three weeks
Secondary Saturated fat per serving per shopping trip Amount of saturated fat (g) per serving purchased based on mean standardized serving sizes within each subcategory. Once a week for three weeks
Secondary Calories per dollar spent per shopping trip Number of calories per dollar (kcal per dollar) spent Once a week for three weeks
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