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Nutrition Intervention Optimization to Better Utilize Resources and Support Health (NOURISH)

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: NICHE Lab Team
  • Telefonnummer: ‪(469) 240-9112‬
  • E-mail: niche@tufts.edu

Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater, 75236
        • Crossroads Community Services
        • Kontakt:
          • NICHE Lab Team
          • Telefonnummer: ‪(469) 240-9112‬
          • E-mail: niche@tufts.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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.

Adfærdsmæssigt: 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).
Eksperimentel: Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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.
Eksperimentel: Condition 3: Pantry, MTG, No-prep meals, and SMS
Pantry provisions, meal kits, no-prep meals, and text messages
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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).
Eksperimentel: Condition 4: Pantry, MTG, and No-prep meals
Pantry provisions, meal kits, and no-prep meals
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Eksperimentel: Condition 5: Pantry, MTG, Culinary classes, and SMS
Pantry provisions, meal kits, culinary nutrition classes, and text messages
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.

Adfærdsmæssigt: 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).
Eksperimentel: Condition 6: Pantry, MTG, and Culinary classes
Pantry provisions, meal kits, and culinary nutrition classes
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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.
Eksperimentel: Condition 7: Pantry, MTG, and SMS
Pantry provisions, meal kits, and text messages
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Adfærdsmæssigt: 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).
Eksperimentel: Condition 8: Pantry and MTG
Pantry provisions and meal kits
Adfærdsmæssigt: 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).
Andre navne:
  • medically tailored groceries
  • MTGs
Eksperimentel: Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
Pantry provisions, no-prep meals, culinary nutrition classes and text messages
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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.

Adfærdsmæssigt: 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).
Eksperimentel: Condition 10: Pantry, No-prep meals, and Culinary classes
Pantry provisions, no-prep meals, and culinary nutrition classes
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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.
Eksperimentel: Condition 11: Pantry, No-prep meals, and SMS
Pantry provisions, no-prep meals, and text messages
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Adfærdsmæssigt: 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).
Eksperimentel: Condition 12: Pantry and No-prep meals
Pantry provisions and no-prep meals
Adfærdsmæssigt: 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.
Andre navne:
  • ready-to-eat meals
  • no prep, ready to eat meals
Eksperimentel: Condition 13: Pantry, Culinary classes, and SMS
Pantry provisions, culinary nutrition classes, and text messages
Adfærdsmæssigt: 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.

Adfærdsmæssigt: 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).
Eksperimentel: Condition 14: Pantry and Culinary classes
Pantry provisions and culinary nutrition classes
Adfærdsmæssigt: 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.
Eksperimentel: Condition 15: Pantry and SMS
Pantry provisions and text messages
Adfærdsmæssigt: 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).
Ingen indgriben: Condition 16: Pantry only
Pantry provisions

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diet
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Household food security
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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).

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tufts University

Samarbejdspartnere

University of Texas Southwestern Medical Center

Efterforskere

  • Ledende efterforsker: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. februar 2031

Studieafslutning (Anslået)

1. februar 2031

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00006929
  • 1R01DK145891-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

June 2027

IPD-delingsadgangskriterier

The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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