NCT04172337

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 18, 2019

Last Update Submit

November 19, 2019

Conditions

Keywords

nutritionfront-of-pack labelcaloriesonline grocery storeSingaporephysical activity equivalent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Proportion of HCS labelled products purchased (or would have been if not in control arm) per shopping trip

    Once a week for three weeks

  • Total Calories per shopping trip

    Once a week for three weeks

  • Diet quality per shopping trip as measured by the Grocery Purchase Quality Index-2016

    Once a week for three weeks

  • Diet quality per shopping trip as measured by weighted average Nutri-Score

    Once a week for three weeks

  • Sugar per serving per shopping trip

    Once a week for three weeks

  • +3 more secondary outcomes

Study Arms (3)

No labeling Control

NO INTERVENTION

Arm 1 was the Control condition, which did not display FOP labels on any products.

HCS-only

EXPERIMENTAL

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.

Behavioral: Healthier Choice Symbol

HCS+PAE

EXPERIMENTAL

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.

Behavioral: Healthier Choice SymbolBehavioral: Physical Activity Equivalent label

Interventions

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.

HCS+PAEHCS-only

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.

HCS+PAE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singapore residents
  • years of age and above
  • Primary grocery shopper for the household

You may not qualify if:

  • Not residing in Singapore
  • Under 21 years of age
  • Not the primary grocery shopper for the household

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Related Publications (1)

  • Finkelstein EA, Doble B, Ang FJL, Wong WHM, van Dam RM. A randomized controlled trial testing the effects of a positive front-of-pack label with or without a physical activity equivalent label on food purchases. Appetite. 2021 Mar 1;158:104997. doi: 10.1016/j.appet.2020.104997. Epub 2020 Oct 13.

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Using a within-person crossover design, participants were randomly assigned to one of six intervention sequences, which included the order of the three shops and when the actual purchase would take place, via random permuted blocks of size three with equal allocation for the six sequences (see Appendix Table A1) by a computer program. Participants were blinded to intervention allocation, which was allocated via the NUSMart system. Allocation results were recorded within NUSMart and all investigators, including the data analyst, were blinded to group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: This will be a crossover study design with all participants exposed once to 3 shopping conditions (1xControl, 1x Arm 2 and 1x Arm 3) in random order. The total study duration for each participant is 3 weeks, with each participant spending 1 week in each shopping condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 21, 2019

Study Start

January 1, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

We will make de-identified data used in the manuscript available to editors upon request either before or after publication for checking.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
10 years after study completion
Access Criteria
Reasonable request

Locations