Nutrition Intervention Optimization to Better Utilize Resources and Support Health

• Meal kits (Behavioral), also known as medically tailored groceries, MTGs: 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), also known as ready-to-eat meals, no prep, ready to eat 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.
• 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

• Diet [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

• 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).]: 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).
• 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).]: 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.
• 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).]: 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

• Adherence [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.
• Implementation Outcomes [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 \[e.g., attending appointments\]).

Sex: All, ages: 18 Years to any

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.

• Kelseanna Hollis-Hansen, PhD, MPH, Principal investigator, Tufts University

NIH grants: R01DK145891