Nutrition Intervention Optimization to Better Utilize Resources and Support Health
NOURISH
Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
2 other identifiers
interventional
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 20, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2031
Study Completion
Last participant's last visit for all outcomes
February 1, 2031
July 20, 2026
July 1, 2026
4.1 years
July 8, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diet
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).
Secondary Outcomes (3)
Household 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
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)
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).
Other Outcomes (2)
Adherence
Through study completion, an average of 6 months (Baseline through 6 months)
Implementation Outcomes
The entirety of the participant being enrolled (6 months)
Study Arms (16)
Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
EXPERIMENTALPantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
EXPERIMENTALPantry provisions, meal kits, no-prep meals, and culinary nutrition classes
Condition 3: Pantry, MTG, No-prep meals, and SMS
EXPERIMENTALPantry provisions, meal kits, no-prep meals, and text messages
Condition 4: Pantry, MTG, and No-prep meals
EXPERIMENTALPantry provisions, meal kits, and no-prep meals
Condition 5: Pantry, MTG, Culinary classes, and SMS
EXPERIMENTALPantry provisions, meal kits, culinary nutrition classes, and text messages
Condition 6: Pantry, MTG, and Culinary classes
EXPERIMENTALPantry provisions, meal kits, and culinary nutrition classes
Condition 7: Pantry, MTG, and SMS
EXPERIMENTALPantry provisions, meal kits, and text messages
Condition 8: Pantry and MTG
EXPERIMENTALPantry provisions and meal kits
Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
EXPERIMENTALPantry provisions, no-prep meals, culinary nutrition classes and text messages
Condition 10: Pantry, No-prep meals, and Culinary classes
EXPERIMENTALPantry provisions, no-prep meals, and culinary nutrition classes
Condition 11: Pantry, No-prep meals, and SMS
EXPERIMENTALPantry provisions, no-prep meals, and text messages
Condition 12: Pantry and No-prep meals
EXPERIMENTALPantry provisions and no-prep meals
Condition 13: Pantry, Culinary classes, and SMS
EXPERIMENTALPantry provisions, culinary nutrition classes, and text messages
Condition 14: Pantry and Culinary classes
EXPERIMENTALPantry provisions and culinary nutrition classes
Condition 15: Pantry and SMS
EXPERIMENTALPantry provisions and text messages
Condition 16: Pantry only
NO INTERVENTIONPantry provisions
Interventions
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).
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- University of Texas Southwestern Medical Centercollaborator
Study Sites (1)
Crossroads Community Services
Dallas, Texas, 75236, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelseanna Hollis-Hansen, PhD, MPH
Tufts University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2026
First Posted
July 20, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
February 1, 2031
Study Completion (Estimated)
February 1, 2031
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- June 2027
- Access Criteria
- The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.