Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05018026 |
| Other study ID # |
Duke-NUS-KPFA/2020/0042 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
January 31, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Duke-NUS Graduate Medical School |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to systematically evaluate the effect of Singapore's new front-of-pack
non-alcoholic beverage labels, called Nutri-Grade, on the consumption of processed beverages.
Using a fully functional grocery webstore, the investigators wish to assess the causal effect
of the new labels on food and beverage purchase, sugar intake, and overall diet quality and
examine how this effect varies by shoppers' income and education level.
The investigators' hypotheses about the effects of these new food labels, measured by the
grams of sugar per serving (primary) of finalized shopping baskets, are as follows:
1. Hypotheses 1: The new sugar-sweetened beverage (SSB) labels will shift consumers toward
healthier products. Sugar-sweetened beverages are any liquids that have been sweetened
with one or more of the different forms of added sugars.
2. Hypotheses 2: The new SSB labels will reduce overall sugar and calories purchased and
increase overall diet quality.
3. Hypotheses 3: Effects will be greater for those with low income/low education as they
are least familiar with the nutrition facts panel and thus most likely to benefit from
the new information.
Description:
1. Experimental Design and Procedures
The aim of this study is to use a 2 x 2 within-subject crossover design with an online
grocery store, to systematically evaluate the effect of the new SSB front-of-pack
labels, Nutri-Grade, on diet quality and examine how this effect varies by shoppers'
income and education level. To this end, the investigators will be using two different
versions of an online experimental grocery store called NUSMart, designed for research
purposes. The two versions are described below.
2. Overview of Experimental Design
The investigators will recruit Singapore residents aged 21 years or older. Prospective
participants will be asked to complete an online screener to determine their eligibility to
participate in the study. Those who do not consent or are deemed ineligible will be notified
of their ineligibility with an on-screen message.
If interested and eligible, the applicant will then be asked to complete a registration form
containing name, mobile number, and email address. Contact information for the Duke-NUS study
team will be provided to allow questions to be asked at any point in the consent process and
throughout the study. Upon completion of the registration form, NUSMart will create the
participant account and a unique ID number (CID) for use throughout the study. Participants
will receive an automated email with their unique login details.
Participants will be directed to read the Participant Information Sheet and provide consent.
The investigators will provide information on study protocols and participation details
without disclosing the intervention arms explicitly, to maintain the integrity of participant
responses and hence to ensure validity of results. It will be deleterious to the study to
reveal the labels or the differences between study arms before participants complete both
shops as this will likely confound participant responses. The consent form will state that in
each of the shops there is a 50% chance that the participant will have to make actual
purchases i.e. buy the groceries in the cart they checked out. In reality, it will be
randomly decided earlier whether shopping trip 1 or 2 is the real shop. This will be achieved
via a collaboration with a local online grocery provider, FairPrice.
After obtaining consent, participants will be asked to fill in a baseline survey to collect
demographic and health characteristics. The baseline questionnaire includes a question as to
whether any household members have a medical condition, such as diabetes or hypertension,
which requires limiting the types of foods they eat.
Eligible participants who have completed to this point will enter a participant waiting list,
where the study team will manually enroll the participant as active according to the capacity
of the study team. Once participants have successfully enrolled in the study they will be
informed by email, and are expected to complete two grocery shops (one shop per week) on
NUSMart. Participants are expected to complete one shop in one sitting. The investigators
will apply a within person design and randomize the order of the two shops. Participants will
receive email and text reminders each week to complete their order.
Each participant will be told that they must buy at least one beverage product and that they
will make the payment using their credit card & receive their grocery orders. This
real-shopping experiment ensures the credibility of the results. Each participant will
therefore shop a total of 2 times during the study. This will include 1 shop within each
shopping condition (Arm 1 and Arm 2).
During the study, participants will be asked to purchase their weekly groceries the amount of
which is similar to their typical grocery shopping for their households, with a specified
minimum spend at each shop. A wheel of purchase will be used to determine which one of the 2
shops will the participant actually pay for and receive ordered goods for. Upon completion of
their second shop, participants will be asked to fill in a short post-study survey asking for
their feedback on the interventions. Participants who successfully complete both shops and
all other surveys will be considered as having completed the study. Participants will be
provided with the debriefing sheet via email after study completion. For the participants who
wish to withdraw midway into the study, the debriefing sheet will be sent to them as soon as
possible after they withdraw.
