Clinical trial

Nutrition Intervention Optimization to Better Utilize Resources and Support Health

Opening soon · Not applicable · 1 countries · Registry ID NCT07713836

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabete Type 2, Obesity & Overweight, Nutritional Intervention, Food Insecurity

Full registry criteria

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.

Treatments and study arms

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).

Primary outcomes

DietRecorded 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Crossroads Community Services🇺🇸 Dallas, Texas, United States
NICHE Lab TeamContact