Nutrition Intervention Optimization to Better Utilize Resources and Support Health

Part of paid clinical trials in Dallas, Texas.

Sponsor
Tufts University
Study ID
NCT07713836
Status
Not Yet Recruiting

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Conditions

  • Diabete Type 2
  • Food Insecurity
  • Nutritional Intervention
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Meal kits — BEHAVIORAL
    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).
  • No-prep meals — BEHAVIORAL
    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.
  • Culinary nutrition classes — BEHAVIORAL
    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.
  • Text messages — BEHAVIORAL
    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).

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Jan 31, 2027
Status verified
Jul 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Experimental: Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
    Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
  • Experimental: Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
    Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
  • Experimental: Condition 3: Pantry, MTG, No-prep meals, and SMS
    Pantry provisions, meal kits, no-prep meals, and text messages
  • Experimental: Condition 4: Pantry, MTG, and No-prep meals
    Pantry provisions, meal kits, and no-prep meals
  • Experimental: Condition 5: Pantry, MTG, Culinary classes, and SMS
    Pantry provisions, meal kits, culinary nutrition classes, and text messages
  • Experimental: Condition 6: Pantry, MTG, and Culinary classes
    Pantry provisions, meal kits, and culinary nutrition classes
  • Experimental: Condition 7: Pantry, MTG, and SMS
    Pantry provisions, meal kits, and text messages
  • Experimental: Condition 8: Pantry and MTG
    Pantry provisions and meal kits
  • Experimental: Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
    Pantry provisions, no-prep meals, culinary nutrition classes and text messages
  • Experimental: Condition 10: Pantry, No-prep meals, and Culinary classes
    Pantry provisions, no-prep meals, and culinary nutrition classes
  • Experimental: Condition 11: Pantry, No-prep meals, and SMS
    Pantry provisions, no-prep meals, and text messages
  • Experimental: Condition 12: Pantry and No-prep meals
    Pantry provisions and no-prep meals
  • Experimental: Condition 13: Pantry, Culinary classes, and SMS
    Pantry provisions, culinary nutrition classes, and text messages
  • Experimental: Condition 14: Pantry and Culinary classes
    Pantry provisions and culinary nutrition classes
  • Experimental: Condition 15: Pantry and SMS
    Pantry provisions and text messages
  • No Intervention: Condition 16: Pantry only
    Pantry provisions

Primary Outcome Measure

Diet [ Time Frame: 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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Crossroads Community ServicesDallasTexas75236
NICHE Lab Team
[email protected]
‪(469) 240-9112‬

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