Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283394
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-17
First Post:
2024-02-21
Brief Title:
AHA American Heart Association Food is Medicine Test of Choice Architecture and Salience of Incentives
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
AHA American Heart Association Food is Medicine Test of Choice Architecture and Salience of Incentives
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 A1C8 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
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
Detailed Description:
Patients who have both obesity BMI 30 and diabetes last A1C8 in the last 90 days will be recruited from specific Penn Medicine primary care practices This patient list is curated based on the inclusionexclusion 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 andor 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 DietID validated a two-minute dietary assessment tool httpswwwdietidcom 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
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 andor 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 DietID validated a two-minute dietary assessment tool httpswwwdietidcom 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None