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NCT Number: NCT07713836

Nutrition Intervention Optimization to Better Utilize Resources and Support Health

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.

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Key information

Conditions

Diabete Type 2 Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Food Insecurity Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional Intervention Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crossroads Community Services

Dallas, Texas, 75236, United States

Location contact

NICHE Lab Team

CONTACT

[email protected]

‪(469) 240-9112‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: medically tailored groceries, MTGs

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.

Other names: ready-to-eat meals, no prep, ready to eat meals

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).

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Household food security

    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).

    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).

  2. Percent body weight change

    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).

    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.

  3. Hemoglobin A1C (HbA1c)

    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).

    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.

Other outcomes

  1. Adherence

    Time frame: 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.

  2. Implementation Outcomes

    Time frame: 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]).

Study contacts

Contact information is provided by the study sponsor or research team.

NICHE Lab Team

CONTACT

[email protected]

‪(469) 240-9112‬

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Official study title

Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients

Acronym: NOURISH

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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