Nutrition Intervention Optimization to Better Utilize Resources and Support Health (NOURISH)
14 lipca 2026 zaktualizowane przez: Tufts University
Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk.
Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs.
This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.
Przegląd badań
Status
Jeszcze nie rekrutacja
Typ studiów
Interwencyjne
Zapisy (Szacowany)
400
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: NICHE Lab Team
- Numer telefonu: (469) 240-9112
- E-mail: niche@tufts.edu
Lokalizacje studiów
-
-
Texas
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Dallas, Texas, Stany Zjednoczone, 75236
- Crossroads Community Services
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Kontakt:
- NICHE Lab Team
- Numer telefonu: (469) 240-9112
- E-mail: niche@tufts.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Aged 18+,
- Body mass index (BMI)≥ 25;
- Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;
- Willingness to complete four in-person data collection appointments;
- Willing and able to consent.
Exclusion Criteria:
- Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);
- Another member of the household participating;
- Planning to move within the next 12 months;
- Unwilling to participate.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Eksperymentalny: Condition 3: Pantry, MTG, No-prep meals, and SMS
Pantry provisions, meal kits, no-prep meals, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 4: Pantry, MTG, and No-prep meals
Pantry provisions, meal kits, and no-prep meals
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
|
|
Eksperymentalny: Condition 5: Pantry, MTG, Culinary classes, and SMS
Pantry provisions, meal kits, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 6: Pantry, MTG, and Culinary classes
Pantry provisions, meal kits, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Eksperymentalny: Condition 7: Pantry, MTG, and SMS
Pantry provisions, meal kits, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 8: Pantry and MTG
Pantry provisions and meal kits
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Inne nazwy:
|
|
Eksperymentalny: Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
Pantry provisions, no-prep meals, culinary nutrition classes and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 10: Pantry, No-prep meals, and Culinary classes
Pantry provisions, no-prep meals, and culinary nutrition classes
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Eksperymentalny: Condition 11: Pantry, No-prep meals, and SMS
Pantry provisions, no-prep meals, and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 12: Pantry and No-prep meals
Pantry provisions and no-prep meals
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Inne nazwy:
|
|
Eksperymentalny: Condition 13: Pantry, Culinary classes, and SMS
Pantry provisions, culinary nutrition classes, and text messages
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Eksperymentalny: Condition 14: Pantry and Culinary classes
Pantry provisions and culinary nutrition classes
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Eksperymentalny: Condition 15: Pantry and SMS
Pantry provisions and text messages
|
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Brak interwencji: Condition 16: Pantry only
Pantry provisions
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Diet
Ramy czasowe: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
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24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers.
Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish.
Will be used to calculate a Healthy Eating Index (HEI) score.
The HEI is a scale from 0 to 100.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Household food security
Ramy czasowe: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Measured using the USDA 6-item household food security survey and will be treated as a continuous variable if normally distributed or a categorical variable if data is non-normal.
Categorical scoring will be based on USDA recommendations (0-1 affirmative responses = high or marginal food security, 2-4 = low food security, 5-6 = very low food security).
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Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
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Percent body weight change
Ramy czasowe: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be calculated as (Baseline weight minus follow-up weight) / (Baseline weight) x 100.
Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.
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Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
|
Hemoglobin A1C (HbA1c)
Ramy czasowe: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be measured using the externally validated point-of-care instrument, DCA VantageAnalyzer (1μl finger stick, nonfasting).
This method has been implemented in food pantries and is less invasive and more cost effective than a venous blood draw.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adherence
Ramy czasowe: Through study completion, an average of 6 months (Baseline through 6 months)
|
Number of meal kits eaten by the participant per month divided by number of meal kits selected per month, number of no-prep meals eaten per month divided by number of no-prep meals selected per month, number of culinary nutrition classes completed, and number of texts read.
|
Through study completion, an average of 6 months (Baseline through 6 months)
|
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Implementation Outcomes
Ramy czasowe: The entirety of the participant being enrolled (6 months)
|
Will measure early-stage implementation outcomes with the follow-up questionnaire (acceptability [intervention satisfaction measures] and through administrative tracking: intervention fidelity (adherence to assigned intervention components [e.g., eating meals, attending classes, etc.] and study protocols [e.g., attending appointments]).
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The entirety of the participant being enrolled (6 months)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 stycznia 2027
Zakończenie podstawowe (Szacowany)
1 lutego 2031
Ukończenie studiów (Szacowany)
1 lutego 2031
Daty rejestracji na studia
Pierwszy przesłany
8 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 lipca 2026
Pierwszy wysłany (Rzeczywisty)
20 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu hormonalnego
- Zaburzenia odżywiania
- Choroby metaboliczne
- Przekarmienie
- Masy ciała
- Zaburzenia metabolizmu glukozy
- Cukrzyca
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Nadwaga
- Otyłość
- Cukrzyca typu 2
- Żywność
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Jedzenie i napoje
- Fast Food
Inne numery identyfikacyjne badania
- STUDY00006929
- 1R01DK145891-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Ramy czasowe udostępniania IPD
June 2027
Kryteria dostępu do udostępniania IPD
The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .