[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713836":3,"trial-entities:NCT07713836":132,"trial-summary:NCT07713836":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":14,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":74,"secondary_outcomes":79,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":105,"locations":108,"central_contacts":124,"overall_officials":126,"references":130,"see_also_links":131},"NCT07713836","STUDY00006929","Nutrition Intervention Optimization to Better Utilize Resources and Support Health","Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients","NOT_YET_RECRUITING","2031-02","2026-07","2026-07-20","2027-01","Tufts University","OTHER",false,"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.",null,[19,20,21,22],"Diabete Type 2","Obesity & Overweight","Nutritional Intervention","Food Insecurity",[24,25,26,27,28],"Food is Medicine","Medically tailored meals","Medically tailored groceries","Type 2 Diabetes","Culinary medicine","INTERVENTIONAL",[31],"NA",{"count":33,"type":34},400,"ESTIMATED",[36,52,63,69],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":49},"BEHAVIORAL","Meal kits","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).",[41,42,43,44,45,46,47,48],"Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS","Condition 2: Pantry, MTG, No-prep meals, and Culinary classes","Condition 3: Pantry, MTG, No-prep meals, and SMS","Condition 4: Pantry, MTG, and No-prep meals","Condition 5: Pantry, MTG, Culinary classes, and SMS","Condition 6: Pantry, MTG, and Culinary classes","Condition 7: Pantry, MTG, and SMS","Condition 8: Pantry and MTG",[50,51],"medically tailored groceries","MTGs",{"type":37,"name":53,"description":54,"armGroupLabels":55,"otherNames":60},"No-prep 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.",[56,57,58,41,42,43,44,59],"Condition 10: Pantry, No-prep meals, and Culinary classes","Condition 11: Pantry, No-prep meals, and SMS","Condition 12: Pantry and No-prep meals","Condition 9: Pantry, No-prep meals, Culinary classes, and SMS",[61,62],"ready-to-eat meals","no prep, ready to eat meals",{"type":37,"name":64,"description":65,"armGroupLabels":66},"Culinary nutrition classes","Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum.\n\nHealth 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.",[56,67,68,41,42,45,46,59],"Condition 13: Pantry, Culinary classes, and SMS","Condition 14: Pantry and Culinary classes",{"type":37,"name":70,"description":71,"armGroupLabels":72},"Text messages","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\u002FSpanish) and scheduled for their preferred time (e.g., AM\u002FPM).",[57,67,73,41,43,45,47,59],"Condition 15: Pantry and SMS",[75],{"measure":76,"description":77,"timeFrame":78},"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.","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).",[80,83,87],{"measure":81,"description":82,"timeFrame":78},"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).",{"measure":84,"description":85,"timeFrame":86},"Percent body weight change","Will be calculated as (Baseline weight minus follow-up weight) \u002F (Baseline weight) x 100. Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.","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).",{"measure":88,"description":89,"timeFrame":86},"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.","ALL","18 Years",{"inclusion":93,"exclusion":99,"raw_text":104},[94,95,96,97,98],"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.",[100,101,102,103],"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.","Inclusion Criteria:\n\n* Aged 18+,\n* Body mass index (BMI)≥ 25;\n* 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;\n* Willingness to complete four in-person data collection appointments;\n* Willing and able to consent.\n\nExclusion Criteria:\n\n* Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);\n* Another member of the household participating;\n* Planning to move within the next 12 months;\n* Unwilling to participate.",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":110,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":121},"Crossroads Community Services","Dallas","Texas","75236","United States",[116],{"name":117,"role":118,"phone":119,"email":120},"NICHE Lab Team","CONTACT","‪(469) 240-9112‬","niche@tufts.edu",{"lat":122,"lon":123},32.78306,-96.80667,[125],{"name":117,"role":118,"phone":119,"email":120},[127],{"name":128,"affiliation":13,"role":129},"Kelseanna Hollis-Hansen, PhD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":136},[134,135],"Obesity","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":138,"summary":139,"prompt_version":149},true,{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is an interventional study, meaning participants will receive specific interventions. It plans to enroll 400 participants.","completed","Nutrition Intervention for Type 2 Diabetes, Obesity, and Food Insecurity","This study, called \"Nutrition Intervention Optimization to Better Utilize Resources and Support Health,\" is looking at different ways to help people with Type 2 diabetes, obesity, or who are overweight, especially those facing food insecurity (not having enough food). Researchers want to see if providing meal kits, ready-to-eat no-prep meals, cooking classes, or text messages can improve diet. You might be eligible if you are 18 or older, have a BMI of 25 or higher, and have access to a device for texts and Wi-Fi. The study will measure changes in your diet over nine months to see which interventions are most helpful. The current status of the study is unclear, but it plans to enroll 400 participants.","Your diet will be measured at baseline, at 3 months, at 6 months (immediately after the intervention period), and at 9 months (three months post-intervention).",118,"You would need to complete four in-person data collection appointments. You would also need to use a device with SMS and MMS text and Wi-Fi capabilities regularly during the study.","Not stated in the trial record.",[38,53,70],"v2"]