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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03761342
Other study ID # NUSMart NM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2018
Est. completion date December 3, 2018

Study information

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

Clinical Trial Summary

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.


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:

1. Arm 1: A control arm that mirrors a traditional web-grocery store with no HCS or other FOP labels.

2. 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.

3. 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:

1. Energy (kCal)

2. Sugar (g)

3. Total fat (g)

4. Saturated fat (g)

5. Sodium (g)

6. Fiber (g)

7. Protein (g) And

8. Average Nutri-Score across all products purchased where A=5 and E=1, and

9. 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.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date December 3, 2018
Est. primary completion date December 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Multiple Traffic Light Label
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.
Nutri-Score Label
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).

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 Diet Quality per shopping trip 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 Total Energy in kilocalories Total Energy (kCal) Once a week for three weeks
Secondary Total Sugar in grams Total Sugar (g) Once a week for three weeks
Secondary Total fat in grams Total Fat (g) Once a week for three weeks
Secondary Saturated fat in grams Saturated Fat (g) Once a week for three weeks
Secondary Sodium in milligrams Sodium (mg) Once a week for three weeks
Secondary Fiber in grams Fiber (g) Once a week for three weeks
Secondary Protein in grams Protein (g) Once a week for three weeks
Secondary Energy per serving in kilocalories per serving Energy per serving (kCal per serving) Once a week for three weeks
Secondary Sugar per serving in grams per serving Sugar per serving (g per serving) Once a week for three weeks
Secondary Total fat per serving in grams per serving Total fat per serving (g per serving) Once a week for three weeks
Secondary Saturated fat per serving in grams per serving Saturated fat per serving (g per serving) Once a week for three weeks
Secondary Sodium per serving in milligrams per serving Sodium per serving (mg per serving) Once a week for three weeks
Secondary Fiber per serving in grams per serving Fiber per serving (g per serving) Once a week for three weeks
Secondary Protein per serving in grams per serving Protein per serving (g per serving) Once a week for three weeks
Secondary Average Nutri-Score across all products purchased 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
Secondary Cost per calorie in dollars per kilocalorie Cost per calorie is calculated as total spend divided by total kilocalories ($ per kCal) Once a week for three weeks
Secondary Total spend in dollars Total spend ($) Once a week for three weeks
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