Optimization Trial to Empower sElection of Nutritious Foods (OPT-TEEN)
September 10, 2026 updated by: New York University
OPT-TEEN: Optimization Trial to Empower sElection of Nutritious Foods
Type 2 diabetes (T2D) disproportionately affects Black and Hispanic youth compared to their White peers.
Although prediabetes can rapidly progress, youth who maintain or lose weight are able to revert the condition.
Youth-led online Diabetes Prevention Programs (DPP) show promise for improving healthy behaviors, but alone does not address systemic barriers, such as affordability, availability, and accessibility of healthy foods, hindering adoption of lifestyle changes.
Low-income Black and Hispanic youth are more likely to live in communities with low access to affordable and healthy foods, that protect against T2D.
Online grocery shopping has the potential to improve access by addressing transportation barriers.
However, delivery fees and digital literacy may unintentionally widen inequities.
To address these gaps, this proposal will leverage existing national programs (USDA's Online Purchasing Pilot and online-DPP) to test three experimental components (Youth-led Online DPP, Financial Incentive, Instant Shoppable List).
This work will aim to 1) conduct formative research to gather barriers, facilitators of fruit, vegetable, and legume (FVL) purchase and consumption among ethnically diverse, low-income families with youth (12-17 years old); 2) determine the combination of intervention components that maximizes the effect on household purchase and youth consumption of FVL and sugar.
A multiphase optimization strategy (MOST) on a 23 factorial randomized, controlled study will estimate both individual and interactive effects of each intervention component.
This research will generate new knowledge about behavioral, social, cultural, environmental, and policy factors that influence healthy eating, which can be used to address disparities in obesity and T2D among low-income youth.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
OPT-TEEN will utilize the Multiphase Optimization Strategy (MOST), a highly efficient methodological approach for intervention development, partnering with the private sector (Instacart) to leverage strategies from the public sector (SNAP) and test three experimental components designed to reduce barriers to online healthy food selection.
These three components consist of 1) an online youth-led advocacy health promotion program (youth-led wellness program), 2) a weekly financial incentive match of up to $10 for purchasing fruits, vegetables, and legumes (FVL) online, and 3) weekly instant shoppable grocery lists featuring tailored meal suggestions using SNAP-Ed recipes.
To promote equity in enrollment and support digital literacy, all participants will receive a baseline package during the 12-week intervention period, informed by a prior pilot study demonstrating that waiving delivery fees enabled more equitable participant enrollment and online grocery uptake, which includes waived online delivery fees, a tutorial video and setup call addressing digital literacy, a monthly service fee waiver (3 in total), and a monthly $5 stipend applied toward service fees (3 in total).
A sample of 200 families with youth ages 12 to 17 who are at risk for Type 2 Diabetes (T2D) and living in low-income urban communities across New York City will be randomized to receive a specific combination of these experimental components for 12 weeks, with component effects tested immediately post-intervention and behavioral maintenance evaluated in the absence of the intervention (no fee waivers or experimental components) at 9 months post-intervention.
Prior to implementation, formative research will be conducted to ensure cultural tailoring and youth relevance by holding 25 to 30 in-depth interviews with Bronx-serving policymakers, community-based organization (CBO) leaders, caregivers, and older youth (ages 18 to 22) with lived experience in the Bronx.
These interviews will guide the development of all intervention materials and research procedures structured around six key dimensions of the Ecological Validity Model: language (wording and tone feedback on materials), persons (recruitment strategies and "buy-in" factors), metaphors (symbols and sayings that resonate), content (grocery items to address food insecurity and cultural appropriateness), methods (evaluation of text messages, online surveys, and delivery), and context (assessing barriers to participation and protocol adherence).
Additionally, the team will conduct 2 to 3 focus group discussions with Bronx youth ages 12 to 22 to gather specific, targeted feedback on the youth-led advocacy health promotion program.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angela Trude, PhD
- Phone Number: 212-988-5456
- Email: at5285@nyu.edu
Study Contact Backup
- Name: Susam Ramos Deulofeutt
- Email: srd389@nyu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Adult (> 21 years old)
Live in a household with a young child(ren) under the age of 18 years and above age 12
Youth must be 12 to 17 and at-risk for Type 2 Diabetes
Primary shopper for the household
Have access to a smartphone or computer to place online orders
Participation in the Supplemental Nutrition Assistance Program in the past year or income eligible (annual household income =< 130% of the federal poverty line)
Agree to share itemized grocery receipts during the study (12 months)
Willing to order groceries online
English or Spanish speaker
Informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Youth-led Wellness Group + Financial Incentive + Shoppable List
Online grocery delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) youth will participate in an online peer-led advocacy group focused on health promotion; 2) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion; 3) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
The participants who are 12 to 17 years of age and are randomized to this component will participate in an online WhatsApp peer-led advocacy group focused on health promotion.
Over the 12 weeks, different themes will be covered on a weekly basis with participants receiving engagement prompts 2 to 3 times a week and weekly activities with the aim to increase knowledge and self-efficacy, fostering sustainable behavior change in nutritional habits.
All messages and activities are evidence-based and use the Social Cognitive Theory Model.
Participants randomized to this component (alone or in combination with another experimental condition) will receive $1 for each dollar spent on fresh, frozen, or canned FVL loaded onto Instacart Fresh Funds, verified based on the submitted online grocery receipt or data from Instacart.
The incentive applies to online purchases only and will not be earned for in-store transactions.
A maximum weekly matched incentive will be set to $10, following the local FV incentive NYC ("Get the Good Stuff").
Fresh Funds earned, supported by Instacart Health, is an infrastructure integrated with retailer payment systems.
Incentives will only be used for purchases of healthier foods (FVL) predetermined by the research team, as it has been used by FV prescription programs.
Participants randomized to this component will receive weekly SNAP-Ed-based meal plans with instant shoppable grocery lists tailored to household size, dietary, and cultural preferences.
All recipes will emphasize FVL-based eating patterns with Hispanic cuisine influences that have FVL as primary ingredients.
Grocery lists organized by store department and recipe, will reflect the nearest available in-store unit.
For example, if one recipe calls for 1 cup of flour, a small flour bag will be added to the list.
Weekly meal plans will be shared via text as a photo and mailed as hard copies, with instant shoppable lists generated through Instacart's List feature as a hyperlink.
Links to the instant shoppable list will be shared via text.
Upon clicking, grocery items will be pre-filled automatically in the participant's online shopping cart.
Participants can modify items and quantities before checking out.
|
|
Experimental: Youth-led Wellness Program + Financial Incentive
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) youth will participate in an online peer-led advocacy group focused on health promotion; 2) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion;
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
The participants who are 12 to 17 years of age and are randomized to this component will participate in an online WhatsApp peer-led advocacy group focused on health promotion.
Over the 12 weeks, different themes will be covered on a weekly basis with participants receiving engagement prompts 2 to 3 times a week and weekly activities with the aim to increase knowledge and self-efficacy, fostering sustainable behavior change in nutritional habits.
All messages and activities are evidence-based and use the Social Cognitive Theory Model.
Participants randomized to this component (alone or in combination with another experimental condition) will receive $1 for each dollar spent on fresh, frozen, or canned FVL loaded onto Instacart Fresh Funds, verified based on the submitted online grocery receipt or data from Instacart.
The incentive applies to online purchases only and will not be earned for in-store transactions.
A maximum weekly matched incentive will be set to $10, following the local FV incentive NYC ("Get the Good Stuff").
Fresh Funds earned, supported by Instacart Health, is an infrastructure integrated with retailer payment systems.
Incentives will only be used for purchases of healthier foods (FVL) predetermined by the research team, as it has been used by FV prescription programs.
|
|
Experimental: Youth-led Wellness Program
Online grocer delivery fee waive, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) youth will participate in an online peer-led advocacy group focused on health promotion.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
The participants who are 12 to 17 years of age and are randomized to this component will participate in an online WhatsApp peer-led advocacy group focused on health promotion.
Over the 12 weeks, different themes will be covered on a weekly basis with participants receiving engagement prompts 2 to 3 times a week and weekly activities with the aim to increase knowledge and self-efficacy, fostering sustainable behavior change in nutritional habits.
All messages and activities are evidence-based and use the Social Cognitive Theory Model.
|
|
Experimental: Financial Incentive + Shoppable List
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion; 2) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
Participants randomized to this component (alone or in combination with another experimental condition) will receive $1 for each dollar spent on fresh, frozen, or canned FVL loaded onto Instacart Fresh Funds, verified based on the submitted online grocery receipt or data from Instacart.
The incentive applies to online purchases only and will not be earned for in-store transactions.
A maximum weekly matched incentive will be set to $10, following the local FV incentive NYC ("Get the Good Stuff").
Fresh Funds earned, supported by Instacart Health, is an infrastructure integrated with retailer payment systems.
Incentives will only be used for purchases of healthier foods (FVL) predetermined by the research team, as it has been used by FV prescription programs.
Participants randomized to this component will receive weekly SNAP-Ed-based meal plans with instant shoppable grocery lists tailored to household size, dietary, and cultural preferences.
All recipes will emphasize FVL-based eating patterns with Hispanic cuisine influences that have FVL as primary ingredients.
Grocery lists organized by store department and recipe, will reflect the nearest available in-store unit.
For example, if one recipe calls for 1 cup of flour, a small flour bag will be added to the list.
Weekly meal plans will be shared via text as a photo and mailed as hard copies, with instant shoppable lists generated through Instacart's List feature as a hyperlink.
Links to the instant shoppable list will be shared via text.
Upon clicking, grocery items will be pre-filled automatically in the participant's online shopping cart.
Participants can modify items and quantities before checking out.
|
|
Experimental: Youth-led Wellness Program + Shoppable List
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) youth will participate in an online peer-led advocacy group focused on health promotion; 2) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
The participants who are 12 to 17 years of age and are randomized to this component will participate in an online WhatsApp peer-led advocacy group focused on health promotion.
Over the 12 weeks, different themes will be covered on a weekly basis with participants receiving engagement prompts 2 to 3 times a week and weekly activities with the aim to increase knowledge and self-efficacy, fostering sustainable behavior change in nutritional habits.
All messages and activities are evidence-based and use the Social Cognitive Theory Model.
Participants randomized to this component will receive weekly SNAP-Ed-based meal plans with instant shoppable grocery lists tailored to household size, dietary, and cultural preferences.
All recipes will emphasize FVL-based eating patterns with Hispanic cuisine influences that have FVL as primary ingredients.
Grocery lists organized by store department and recipe, will reflect the nearest available in-store unit.
For example, if one recipe calls for 1 cup of flour, a small flour bag will be added to the list.
Weekly meal plans will be shared via text as a photo and mailed as hard copies, with instant shoppable lists generated through Instacart's List feature as a hyperlink.
Links to the instant shoppable list will be shared via text.
Upon clicking, grocery items will be pre-filled automatically in the participant's online shopping cart.
Participants can modify items and quantities before checking out.
|
|
Experimental: Shoppable List
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
Participants randomized to this component will receive weekly SNAP-Ed-based meal plans with instant shoppable grocery lists tailored to household size, dietary, and cultural preferences.
All recipes will emphasize FVL-based eating patterns with Hispanic cuisine influences that have FVL as primary ingredients.
Grocery lists organized by store department and recipe, will reflect the nearest available in-store unit.
For example, if one recipe calls for 1 cup of flour, a small flour bag will be added to the list.
Weekly meal plans will be shared via text as a photo and mailed as hard copies, with instant shoppable lists generated through Instacart's List feature as a hyperlink.
Links to the instant shoppable list will be shared via text.
Upon clicking, grocery items will be pre-filled automatically in the participant's online shopping cart.
Participants can modify items and quantities before checking out.
|
|
Experimental: Financial Incentive
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
Plus: 1) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
Participants randomized to this component (alone or in combination with another experimental condition) will receive $1 for each dollar spent on fresh, frozen, or canned FVL loaded onto Instacart Fresh Funds, verified based on the submitted online grocery receipt or data from Instacart.
The incentive applies to online purchases only and will not be earned for in-store transactions.
A maximum weekly matched incentive will be set to $10, following the local FV incentive NYC ("Get the Good Stuff").
Fresh Funds earned, supported by Instacart Health, is an infrastructure integrated with retailer payment systems.
Incentives will only be used for purchases of healthier foods (FVL) predetermined by the research team, as it has been used by FV prescription programs.
|
|
Active Comparator: Delivery fee waived only
Online grocer delivery fee waiver, a monthly one-time use service fee waiver (3 in total), a monthly one-time use $5 stipend (3 in total) and a tutorial video addressing digital literacy will be constant components, meaning that it will be available to all participants in the study.
|
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping.
The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish.
Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video.
To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership.
Phone follow-ups were well-received during the pilot.
Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders >$10.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Household Purchase of Fruit, Vegetable, and Legumes
Time Frame: 6 weeks, 12 weeks, and 12 months
|
Change in household purchase of fruits, vegetables, and legumes (online and in-store) from baseline will be assessed via itemized grocery receipts obtained via text messages mid-intervention (6-week), post-intervention (12-week), and maintenance (12 months).
|
6 weeks, 12 weeks, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Youth Consumption of Fruit, Vegetable, and Legumes
Time Frame: 12 weeks and 12 months
|
Change in consumption of fruits and vegetables from baseline will be assessed via self-reported questionnaires utilizing the Block Food Frequency (FFQ) questionnaire for youth reported online at baseline, 12-week from baseline and 12-months from baseline.
|
12 weeks and 12 months
|
|
Parent/Caregiver Consumption of Fruit, Vegetable, and Legumes
Time Frame: 12 weeks
|
Change in consumption of fruits and vegetables from baseline will be assessed via self-reported questionnaires utilizing the Dietary Screener Questionnaire (DSQ) for adults reported online at baseline and 12-weeks from baseline.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: 12 weeks
|
Change in Body Mass Index from baseline will be measured by self-reported height and weight from adults and youth at baseline and 12-week.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angela Trude, PhD, New York University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
August 20, 2026
First Submitted That Met QC Criteria
September 10, 2026
First Posted (Actual)
September 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-FY2026-11088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At this time, there are no plans to share IPD due to limitations related to participant privacy, the sensitive nature of the data collected, and constraints in the informed consent process that do not allow for broad data sharing.
While the investigators support data transparency, any future sharing would require additional ethical review and participant re-consent to ensure privacy protections are upheld.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.