Food SelectionNCT04165447
Evaluating the Effectiveness of Within Versus Across-Category Front-of-Package Lower-Calorie Labelling on Food Demand
A study testing Front-of-pack labeling strategy in people with Food Selection, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The important role that diet plays in health and disease is well established, as is its association with rising rates of obesity-a phenomenon of increasing concern in Singapore. Changes in lifestyle patterns, including a movement towards a more western-style diet with an emphasis on pre-packaged and fast food, have… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Front-of-pack labeling strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2017to 30 Apr 2018
- 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
- Adults aged 21 years and above
- Primary grocery shopper for the household
- Registered RedMart (an online grocery store) shoppers
Who cannot join
- Under 21 years of age
- Not the primary grocery shopper for the household
- Not a resident in Singapore
- Not a registered online shopper of RedMart
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Evaluating the Effectiveness of Within Versus Across-Category Front-of-Package Lower-Calorie Labelling on Food Demand
The important role that diet plays in health and disease is well established, as is its association with rising rates of obesity-a phenomenon of increasing concern in Singapore. Changes in lifestyle patterns, including a movement towards a more western-style diet with an emphasis on pre-packaged and fast food, have contributed to the upward trend in weight. This study aims to test two competing approaches for calorie labelling in efforts to reduce total calories purchased. In Arm 1 (termed across category labelling) a low calorie logo will be displayed on the 20% of products on the web store that are lowest in calories per serving. Arm 2 will display this logo on the 20% of products that are lowest in calories per serving within each product category (termed within category labelling). Arm 3 is the Control condition which will not display any logo on any products.
For our primary outcome, the investigators hypothesize that the proportion of labelled products (or those that would have been labelled if not in control arm) purchased in each intervention arm will be greater than in control.
Read more
For secondary hypotheses the investigators expect the following ordering across the three (Control, Within category, Across category) arms:
- total calories (adjusted for household size): C > A > W
- calories per serving: C > A > W
- calories per dollar spent: W > A > C
- total dollars spent (adjusted for household size) : W > A > C
Read the detailed description
For this study an online grocery store was developed that contains over 3200 products commonly purchased in local supermarkets. The products available for purchase include foods from many different categories such as dairy products, snacks, processed meats and soft drinks. The web-based grocery store was designed to mirror an actual web-based grocery store in look and feel. All products include a picture of the item, current retail price, the Lower Calorie logo (where applicable), and other package size and nutrition information currently required for products in Singapore. The online grocery store features a grocery cart that shows the items purchased. The NUS Online Collection Facility payment system has been integrated with the online grocery store for participants to make payments.
Study design: This will be a crossover study design with all participants exposed once to 3 shopping conditions (1xControl, 1xIntervention 1 (I1), 1x Intervention 2(I2)) in random order. The total study duration for each participant is 3 weeks, with each participant spending 1 week in each shopping condition.
For the Control condition the participants are not exposed to the lower calorie logo. For Intervention 1 (Across), the participant will see the lower calorie logo applied to foods with the lowest calories per serving across all food categories. For intervention 2, the participant will see the lower calorie logo applied to the 20% of foods with the lowest calories per serving within each food category. These foods will be tagged with the 'Lower Calorie' logo.
Participants will be asked to shop once a week during each of the 3 weeks of the study, and will therefore shop for a total of 3 times during the study. This will include 1 shop within each shopping condition (control, I1, and I2). Participants will purchase and receive at least 1 and up to 3 of their grocery orders. This ensures that purchases will be an accurate reflection of their actual shopping experience.
Since there are 3 shopping conditions (Control, I1, and I2) and the specific weeks that the participant's shopping trips will be pre-determined for purchase (but unknown to participants), each participant will be randomly assigned at baseline to 1 of 6 groups that vary the sequence of shopping conditions and which shops will result in an actual food delivery.
For each shop there will be a minimum spend of SGD50 and a maximum spend of SGD250. A minimum spend ensures that participants complete a typical weekly grocery order. A maximum spend is to make the study more manageable given foods will need to be reordered and delivered. The grocery orders that participants purchase will be ordered by Duke-NUS using RedMart, a popular online grocery store in Singapore, and RedMart will deliver the grocery items. The store was created using products currently available on the RedMart website to allow us to repurchase from a single location.
Redmart is engaged in this project as our collaborator. As such, the relationship between the Parties is that of independent contractor and contractee. Neither party is an agent of the other nor have any right or authority to create any obligation or responsibility on behalf of the other. Neither is Duke-NUS in any way endorsing or marketing the services of Redmart.
At the end of the study participants who have completed all 3 shops as instructed will receive a RedMart e-Voucher worth $75 payment that can be redeemed against any products on RedMart.
- Conditions
- Food Selection
- Being tested
- Front-of-pack labeling strategy
- Keywords
- nutrition, front-of-pack label, calories, online grocery store, diet, groceries, obesity
- Medical subject headings
- Food Preferences, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Front-of-pack labeling strategyBehavioural
We designed a simple 'Lower Calorie' directive logo. We labeled the 20% of products with the lowest calories per serving within or across categories. All serving sizes used in this study were the average of the serving sizes within each category. Prior to conducting the analysis, we standardized the serving size by using the mean serving size within each subcategory. This standardization ensures that similar products are compared equally as serving sizes can be arbitrarily set by the manufacturers. The labels were displayed below the product images.
| Study group | Role | What they receive |
|---|---|---|
| No labeling Control | No intervention | Arm 1 was the Control condition, which did not display the label on any products. |
| Within-category labeling | Experimental | Arm 2 displayed the label on the 20% of products that were lowest in calories per serving within each product category (termed Within-category Labeling, WC). Receives: Behavioral: Front-of-pack labeling strategy |
| Across-category labeling | Experimental | Arm 3 displayed the label on the 20% of all products that were lowest in calories per serving (termed Across-category Labeling, AC). Receives: Behavioral: Front-of-pack labeling strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the basket represented by Lower Calorie products per shopping trip
Proportion of products that are designated as labelled in the interventions
Measured: Once a week for three weeks
Secondary outcomes (4)
Calories purchased per dollar spent per shopping trip
Calories purchased per dollar spent in kcal per $
Measured: Once a week for three weeks
Total spending per shopping trip
Total spending ($)
Measured: Once a week for three weeks
Total calories purchased per shopping trip
Total calories purchased (in kcal)
Measured: Once a week for three weeks
Calories per serving per shopping trip
Calories per serving (in kcal/serving)
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.
- First posted18 Nov 2019
- Study start1 Oct 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165447
- Sponsor's protocol ID
- AG-2014-001
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. All data will be de-identified.
Publications
Finkelstein EA, Ang FJL, Doble B. Randomized trial evaluating the effectiveness of within versus across-category front-of-package lower-calorie labelling on food demand. BMC Public Health. 2020 Mar 12;20(1):312. doi: 10.1186/s12889-020-8434-1.
PubMed 32164634
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating the Effectiveness of Within Versus Across-Category Front-of-Package Lower-Calorie Labelling on Food Demand
- ClinicalTrials.gov ID
- NCT04165447
- Acronym / sponsor ID
- AG-2014-001
- Conditions
- Food Selection
- Keywords
- nutrition, front-of-pack label, calories, online grocery store, diet, groceries, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The important role that diet plays in health and disease is well established, as is its association with rising rates of obesity-a phenomenon of increasing concern in Singapore. Changes in lifestyle patterns, including a movement towards a more western-style diet with an emphasis on pre-packaged and fast food, have contributed to the upward trend in weight. This study aims to test two competing approaches for calorie labelling in efforts to reduce total calories purchased. In Arm 1 (termed across category labelling) a low calorie logo will be displayed on the 20% of products on the web store that are lowest in calories per serving. Arm 2 will display this logo on the 20% of products that are lowest in calories per serving within each product category (termed within category labelling). Arm 3 is the Control condition which will not display any logo on any products.
For our primary outcome, the investigators hypothesize that the proportion of labelled products (or those that would have been labelled if not in control arm) purchased in each intervention arm will be greater than in control.
For secondary hypotheses the investigators expect the following ordering across the three (Control, Within category, Across category) arms:
- total calories (adjusted for household size): C > A > W
- calories per serving: C > A > W
- calories per dollar spent: W > A > C
- total dollars spent (adjusted for household size) : W > A > C
Detailed description
For this study an online grocery store was developed that contains over 3200 products commonly purchased in local supermarkets. The products available for purchase include foods from many different categories such as dairy products, snacks, processed meats and soft drinks. The web-based grocery store was designed to mirror an actual web-based grocery store in look and feel. All products include a picture of the item, current retail price, the Lower Calorie logo (where applicable), and other package size and nutrition information currently required for products in Singapore. The online grocery store features a grocery cart that shows the items purchased. The NUS Online Collection Facility payment system has been integrated with the online grocery store for participants to make payments.
Study design: This will be a crossover study design with all participants exposed once to 3 shopping conditions (1xControl, 1xIntervention 1 (I1), 1x Intervention 2(I2)) in random order. The total study duration for each participant is 3 weeks, with each participant spending 1 week in each shopping condition.
For the Control condition the participants are not exposed to the lower calorie logo. For Intervention 1 (Across), the participant will see the lower calorie logo applied to foods with the lowest calories per serving across all food categories. For intervention 2, the participant will see the lower calorie logo applied to the 20% of foods with the lowest calories per serving within each food category. These foods will be tagged with the 'Lower Calorie' logo.
Participants will be asked to shop once a week during each of the 3 weeks of the study, and will therefore shop for a total of 3 times during the study. This will include 1 shop within each shopping condition (control, I1, and I2). Participants will purchase and receive at least 1 and up to 3 of their grocery orders. This ensures that purchases will be an accurate reflection of their actual shopping experience.
Since there are 3 shopping conditions (Control, I1, and I2) and the specific weeks that the participant's shopping trips will be pre-determined for purchase (but unknown to participants), each participant will be randomly assigned at baseline to 1 of 6 groups that vary the sequence of shopping conditions and which shops will result in an actual food delivery.
For each shop there will be a minimum spend of SGD50 and a maximum spend of SGD250. A minimum spend ensures that participants complete a typical weekly grocery order. A maximum spend is to make the study more manageable given foods will need to be reordered and delivered. The grocery orders that participants purchase will be ordered by Duke-NUS using RedMart, a popular online grocery store in Singapore, and RedMart will deliver the grocery items. The store was created using products currently available on the RedMart website to allow us to repurchase from a single location.
Redmart is engaged in this project as our collaborator. As such, the relationship between the Parties is that of independent contractor and contractee. Neither party is an agent of the other nor have any right or authority to create any obligation or responsibility on behalf of the other. Neither is Duke-NUS in any way endorsing or marketing the services of Redmart.
At the end of the study participants who have completed all 3 shops as instructed will receive a RedMart e-Voucher worth $75 payment that can be redeemed against any products on RedMart.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No labeling Control | No intervention | –Arm 1 was the Control condition, which did not display the label on any products. |
| Within-category labeling | Experimental | Behavioral: Front-of-pack labeling strategyArm 2 displayed the label on the 20% of products that were lowest in calories per serving within each product category (termed Within-category Labeling, WC). |
| Across-category labeling | Experimental | Behavioral: Front-of-pack labeling strategyArm 3 displayed the label on the 20% of all products that were lowest in calories per serving (termed Across-category Labeling, AC). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 21 years and above
- Primary grocery shopper for the household
- Registered RedMart (an online grocery store) shoppers
Key exclusion criteria (4 listed)
- Under 21 years of age
- Not the primary grocery shopper for the household
- Not a resident in Singapore
- Not a registered online shopper of RedMart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Front-of-pack labeling strategyWe designed a simple 'Lower Calorie' directive logo. We labeled the 20% of products with the lowest calories per serving within or across categories. All serving sizes used in this study were the average of the serving sizes within each category. Prior to conducting the analysis, we standardized the serving size by using the mean serving size within each subcategory. This standardization ensures that similar products are compared equally as serving sizes can be arbitrarily set by the manufacturers. The labels were displayed below the product images. | Behavioural | Across-category labeling, Within-category labeling |
Primary outcome
Proportion of the basket represented by Lower Calorie products per shopping trip
Time frame: Once a week for three weeks
Proportion of products that are designated as labelled in the interventions
4 secondary outcomes
Calories purchased per dollar spent per shopping trip
Time frame: Once a week for three weeks
Total spending per shopping trip
Time frame: Once a week for three weeks
Total calories purchased per shopping trip
Time frame: Once a week for three weeks
Calories per serving per shopping trip
Time frame: Once a week for three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 32164634Finkelstein EA, Ang FJL, Doble B. Randomized trial evaluating the effectiveness of within versus across-category front-of-package lower-calorie labelling on food demand. BMC Public Health. 2020 Mar 12;20(1):312. doi: 10.1186/s12889-020-8434-1.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. All data will be de-identified.
Related trials for Food Selection
Not yet recruiting
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Influence of Social Media Ads on Food Choice - Master Protocol
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Optimization Trial to Empower sElection of Nutritious Foods
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Not yet recruiting
Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
Food Labelling, Eating Behaviour
RecruitingObservational study
Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
CKD, Chronic Kidney Disease (Stages 3b-5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Front-of-pack labeling strategy in people with Food Selection, 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 4 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 18 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?
Proportion of the basket represented by Lower Calorie products 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 NCT04165447, 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 18 Nov 2019.