An interventional study of Meal kits and No-prep meals in Diabete Type 2, Obesity & Overweight and Nutritional Intervention, sponsored by Tufts University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Tufts University · Not applicable, Interventional, and Other
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 400 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
Behavioral: Meal kits · Behavioral: No-prep meals · Behavioral: Culinary nutrition classes · Behavioral: Text messages
Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
Behavioral: Meal kits · Behavioral: No-prep meals · Behavioral: Culinary nutrition classes
Pantry provisions, meal kits, no-prep meals, and text messages
Behavioral: Meal kits · Behavioral: No-prep meals · Behavioral: Text messages
Pantry provisions, meal kits, and no-prep meals
Behavioral: Meal kits · Behavioral: No-prep meals
Pantry provisions, meal kits, culinary nutrition classes, and text messages
Behavioral: Meal kits · Behavioral: Culinary nutrition classes · Behavioral: Text messages
Pantry provisions, meal kits, and culinary nutrition classes
Behavioral: Meal kits · Behavioral: Culinary nutrition classes
Pantry provisions, meal kits, and text messages
Behavioral: Meal kits · Behavioral: Text messages
Pantry provisions and meal kits
Behavioral: Meal kits
Pantry provisions, no-prep meals, culinary nutrition classes and text messages
Behavioral: No-prep meals · Behavioral: Culinary nutrition classes · Behavioral: Text messages
Pantry provisions, no-prep meals, and culinary nutrition classes
Behavioral: No-prep meals · Behavioral: Culinary nutrition classes
Pantry provisions, no-prep meals, and text messages
Behavioral: No-prep meals · Behavioral: Text messages
Pantry provisions and no-prep meals
Behavioral: No-prep meals
Pantry provisions, culinary nutrition classes, and text messages
Behavioral: Culinary nutrition classes · Behavioral: Text messages
Pantry provisions and culinary nutrition classes
Behavioral: Culinary nutrition classes
Pantry provisions and text messages
Behavioral: Text messages
Pantry provisions
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).
Also known as: medically tailored groceries, MTGs
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.
Also known as: ready-to-eat meals, no prep, ready to eat meals
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).
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.
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).
Household food security
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).
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).
Percent body weight change
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.
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).
Hemoglobin A1C (HbA1c)
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.
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).
Adherence
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.
Time frame: Through study completion, an average of 6 months (Baseline through 6 months)
Implementation Outcomes
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 \[e.g., attending appointments\]).
Time frame: The entirety of the participant being enrolled (6 months)
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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