Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06283394 |
| Other study ID # |
854803 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2024 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of Pennsylvania |
| Contact |
Samantha Coratti, B.S. |
| Phone |
7325973650 |
| Email |
samantha.coratti[@]pennmedicine.upenn.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this interventional study is to test ways to improve the effectiveness of a
healthy foods prescription program in increasing the purchase of healthy foods for patients
who have both obesity (BMI > 30) and diabetes (last A1C>8 in the last 90 days). The main
questions it aims to answer are:
Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment
among those identified as eligible, rates of Instacart platform use, amount of the subsidy
used each week, and amounts of healthy foods ordered.
Aim 2: Examine strategies to optimize the user experience of trial participation, including
communication strategies and on-boarding, to increase uptake and engagement in this and
subsequent studies.
Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on
Instacart, and they will not receive any modifications to the virtual storefront on
Instacart. They will have access to the standard Instacart platform and Instacart +
memberships with $5 per week to cover service and delivery fees and delivery tips for 3
months.
Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month
for 3 months to be used on produce (fruits and vegetables).
Description:
Patients who have both obesity (BMI > 30) and diabetes (last A1C>8 in the last 90 days) will
be recruited from specific Penn Medicine primary care practices. This patient list is curated
based on the inclusion/exclusion criteria.
Participants in the control group will receive usual care (defined as access to the the
virtual storefront without the choice architecture manipulation) but all study participants
will receive a free Instacart+ membership for the 3 months they are a study participant and
be given $20 per month to help cover the cost of additional delivery and service fees as well
as tips for delivery drivers on Instacart. Participants in the intervention groups will in
addition receive $160 per month in subsidies on Instacart. All arms will receive text
messages and/or email messages from W2H 1x per week with a link to Instacart and different
messaging depending on the study arm.
The main difference between the pilot intervention and the main RCT is the length (2 weeks
for the pilot, 3 months for the main RCT); otherwise, they will receive the same experience.
The pilot phase intends to test out a mini version of the full intervention and get
participant feedback so that the study team can improve the user experience before conducting
the main intervention study.
Participants in 4 of the 5 study arms will be given vouchers for use on Instacart to buy
fruit and vegetables ($160 a month). They will be given an individualized link to a special
study website that is an Instacart virtual store where they can order food items to be
delivered. Weekly, Instacart will send us data on how much is left in terms of unexpended
vouchers and what food is purchased for each study ID each month.
Initial Feasibility Tests (2 Weeks): Before enrolling participants in this phase of the
study, the study team will examine strategies for uptake and engagement through a series of
two rapid 10-person studies followed by semi-structured interviews to gather feedback on ways
to improve the user experience. There will be 2 cohorts of 10 participants randomized 2 in
each of the 5 study arms. Each interview will be audio-recorded with permission from the
participant and subsequently transcribed for analysis. Interviews will take place over the
phone or on Zoom and will be recorded using an audio recorder. Audio files will be uploaded
to a third-party professional transcription service, which will transcribe the recordings and
send us the transcripts for analysis. Participants that sign up for their Instacart account
within 48 hours will receive a $25 Instacart gift card. All participants in the intervention
arms during this phase will receive $40 per week for two weeks to be used to subsidize the
purchase of foods on the healthy foods list (denoted by Instacart on the virtual storefront).
Participants in the control arm will receive $5 per week for two weeks to cover additional
service fees, delivery fees, and driver tips. This will be done twice to reach high rates of
initial enrollment and ongoing engagement. This will also test the integration of our trial
platform (W2H), connection to Instacart, and receipt of data from Instacart at the individual
level. These iterative studies will be used to get participant input into the user experience
and to streamline our on-boarding processes. Participants will also receive $50 to debrief
with the study team on their experience. Before advancing to the intervention trial, success
during this stage will be assessed as more than 35% of approached participants enroll and
start using the platform to order healthy foods.
Randomized Controlled Trial (3 Months): The study team then plans to test modifying choice
architecture and different ways of presenting incentives to affect the degree to which these
strategies change healthy food purchasing behavior.
All participants will start in the study at the beginning of the month. If they do not
complete their enrollment by the 5th day of the month, they will be paused until the 1st day
of the following month.
In the RCT phase, participants will be reached out to by text and sent to a Way to Health
study link where they will be asked to first complete a brief eligibility survey via text
message. Eligibility questions include whether the participant is interested in participating
in a study involving online shopping, if they have internet access, and if they have a backup
payment method for foods they purchase over and above the value of the subsidies.
Participants will complete dietary recall questionnaires at 0 and 3 months via W2H. The study
team will use the Diet.ID validated a two-minute dietary assessment tool
(https://www.dietid.com/). As part of the 3-month assessment, participants will be asked
questions about their study experience. Participants will be compensated $25 for the 0-month
dietary survey and $75 for completing the 3-month dietary survey and exit survey and
hemoglobin A1c lab after 3 months.
At the completion of the 3-month study period, a subset of participants (total of 42,
selecting those with highest and lowest % of fruit and vegetable voucher use each month) will
be invited to complete semi-structured exit interviews conducted by a trained research
coordinator over the phone or through Zoom. Participants will receive an extra $50 for
completing these interviews.
