Nutrition Intervention Optimization to Better Utilize Resources and Support Health (NOURISH)
14 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Ingrijpend
Inschrijving (Geschat)
400
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: NICHE Lab Team
- Telefoonnummer: (469) 240-9112
- E-mail: niche@tufts.edu
Studie Locaties
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75236
- Crossroads Community Services
-
Contact:
- NICHE Lab Team
- Telefoonnummer: (469) 240-9112
- E-mail: niche@tufts.edu
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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).
Andere namen:
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.
Andere namen:
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).
|
|
Experimenteel: 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).
Andere namen:
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.
Andere namen:
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. |
|
Experimenteel: 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).
Andere namen:
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.
Andere namen:
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).
|
|
Experimenteel: 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).
Andere namen:
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.
Andere namen:
|
|
Experimenteel: 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).
Andere namen:
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).
|
|
Experimenteel: 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).
Andere namen:
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. |
|
Experimenteel: 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).
Andere namen:
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).
|
|
Experimenteel: 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).
Andere namen:
|
|
Experimenteel: 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.
Andere namen:
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).
|
|
Experimenteel: 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.
Andere namen:
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. |
|
Experimenteel: 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.
Andere namen:
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).
|
|
Experimenteel: 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.
Andere namen:
|
|
Experimenteel: 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).
|
|
Experimenteel: 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. |
|
Experimenteel: 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).
|
|
Geen tussenkomst: Condition 16: Pantry only
Pantry provisions
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diet
Tijdsspanne: 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).
|
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).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Household food security
Tijdsspanne: 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).
|
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).
|
|
Percent body weight change
Tijdsspanne: 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.
|
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)
Tijdsspanne: 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).
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence
Tijdsspanne: 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)
|
|
Implementation Outcomes
Tijdsspanne: 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]).
|
The entirety of the participant being enrolled (6 months)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 januari 2027
Primaire voltooiing (Geschat)
1 februari 2031
Studie voltooiing (Geschat)
1 februari 2031
Studieregistratiedata
Eerst ingediend
8 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 juli 2026
Eerst geplaatst (Werkelijk)
20 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
14 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Voedingsstoornissen
- Metabole ziekten
- Overvoeding
- Lichaamsgewicht
- Glucosemetabolismestoornissen
- Suikerziekte
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Overgewicht
- Obesitas
- Diabetes mellitus, type 2
- Voedsel
- Dieet, voedsel en voeding
- Fysiologische fenomenen
- Eten en dranken
- Fastfood
Andere studie-ID-nummers
- STUDY00006929
- 1R01DK145891-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
IPD-tijdsbestek voor delen
June 2027
IPD-toegangscriteria voor delen
The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .