Optimization Trial to Empower sElection of Nutritious Foods (OPT-TEEN)
10. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Angela Trude, PhD
- Telefonní číslo: 212-988-5456
- E-mail: at5285@nyu.edu
Studijní záloha kontaktů
- Jméno: Susam Ramos Deulofeutt
- E-mail: srd389@nyu.edu
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Household Purchase of Fruit, Vegetable, and Legumes
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Youth Consumption of Fruit, Vegetable, and Legumes
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body Mass Index
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Angela Trude, PhD, New York University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. ledna 2027
Primární dokončení (Odhadovaný)
31. prosince 2028
Dokončení studie (Odhadovaný)
31. prosince 2030
Termíny zápisu do studia
První předloženo
20. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
10. září 2026
První zveřejněno (Aktuální)
11. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. září 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB-FY2026-11088
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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