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ObesityNCT04172337

Testing the Effects of Singapore's Front-of-Pack Healthier Choice Symbol Label With or Without a Physical Activity Equivalent Label

A study testing Healthier Choice Symbol and Physical Activity Equivalent label in people with Obesity and Diabetes, 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

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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes, Diet, Healthy
What is being tested?
Healthier Choice Symbol and Physical Activity Equivalent label
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteSingapore
Study dates
1 Jan 2019to 30 Apr 2019
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Duke-NUS Medical School

    Singapore, 169857

Other trials in Singapore

About this study

Official title: 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.

Read more

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.

Being tested
Healthier Choice Symbol, Physical Activity Equivalent label
Keywords
nutrition, front-of-pack label, calories, online grocery store, Singapore, physical activity equivalent
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthier Choice SymbolBehavioural

    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 labelBehavioural

    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.

Study groups in NCT04172337
Study groupRoleWhat they receive
No labeling ControlNo interventionArm 1 was the Control condition, which did not display FOP labels on any products.
HCS-onlyExperimentalArm 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.
Receives: Behavioral: Healthier Choice Symbol
HCS+PAEExperimentalArm 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.
Receives: Behavioral: Healthier Choice Symbol; Behavioral: Physical Activity Equivalent label

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Once a week for three weeks

Secondary outcomes (8)

  1. 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.

    Measured: Once a week for three weeks

  2. Total Calories per shopping trip

    Total calories purchased in kcal.

    Measured: Once a week for three weeks

  3. 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.

    Measured: Once a week for three weeks

  4. 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.

    Measured: Once a week for three weeks

  5. Sugar per serving per shopping trip

    Amount of sugar (g) per serving purchased based on mean standardized serving sizes within each subcategory.

    Measured: Once a week for three weeks

  6. Sodium per serving per shopping trip

    Amount of sodium (mg) per serving purchased based on mean standardized serving sizes within each subcategory.

    Measured: Once a week for three weeks

  7. Saturated fat per serving per shopping trip

    Amount of saturated fat (g) per serving purchased based on mean standardized serving sizes within each subcategory.

    Measured: Once a week for three weeks

  8. Calories per dollar spent per shopping trip

    Number of calories per dollar (kcal per dollar) spent

    Measured: Once a week for three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start1 Jan 2019
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

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
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172337
Sponsor's protocol ID
NMRC-HSRG-0060-2016
Status last verified
Nov 2019
First submitted
18 Nov 2019
Last updated
21 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will make de-identified data used in the manuscript available to editors upon request either before or after publication for checking.

Publications

  • 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.

    PubMed 33065191

Questions about this trial

What is this clinical trial studying?

A study testing Healthier Choice Symbol and Physical Activity Equivalent label in people with Obesity and Diabetes, 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 3 inclusion and 3 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 21 Nov 2019. 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?

Change in average calories per serving purchased per shopping trip (time frame: Once a week for three weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172337, which also lists 1 linked publication.

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 21 Nov 2019.

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