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The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework. Participants will be randomized 1:1 to FIM+DASH or usual-care control. The 24-week trial includes a 12-week FIM+DASH intervention followed by a 12-week maintenance period and leverages existing partnerships with community-based organizations for home food delivery and culinary skill-skill building. The main questions it aims to answer are: (1) What is the effect of FIM+DASH vs. usual care control on blood pressure? (2) What is the effect of FIM+DASH vs. usual care control on DASH diet adherence (diet quality), body weight, and waist circumference? (3) How to identify factors associated with the sustainability and scalability of FIM+DASH in real-world settings?
FIM+DASH is adapted from the FIM+DASH pilot and informed by prior NIH-funded dietary interventions integrating clinic-community partnerships for culinary skill building and home food delivery. The intervention is designed to strengthen clinic-to-community linkages that support adoption and maintenance of a DASH eating pattern and hypertension (HTN) self-management for weight and BP control. Core components include in-person group and on-demand culinary skill-building, group and on-demand didactic content for DASH adoption and adherence and HTN self-management, brief one-on-one check-ins with a nutrition professional, and weekly DASH-friendly home food delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIM Usual Care Arm | Active Comparator | Participants randomized to the usual care arm continue to receive routine clinical care. They do not receive the FIM+DASH intervention during the active intervention period, but they complete study assessments according to the same assessment schedule. If your protocol includes delayed intervention materials/equipment/classes/food support after the primary trial period, include that here. |
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| FIM Intervention Arm | Experimental | Participants randomized to the experimental arm receive the FIM+DASH intervention, which includes Food is Medicine support aligned with DASH dietary guidance. The intervention includes groceries/food support, cooking/nutrition education, behavioral support, self-monitoring tools, and participant follow-up as specified in the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIM intervention arm | Combination Product | For weeks 1-12: Culinary skill-building: 8 In-person and remote sessions will teach participants core techniques (knife skills, batch cooking, sodium-aware seasoning, whole-grain preparation, vegetable-forward entrées, low fat dairy use, lean-protein methods). DASH-friendly home food delivery. Participants will receive 12 weekly deliveries that provide items consistent with DASH (e.g., fruits/vegetables, low-fat dairy [lactose-free available], whole grains, lean proteins) dietary regimen. Participants will receive one-on-one support sessions with the interventionist to reinforce DASH adoption/adherence and HTN self-management tasks. For weeks 13-24, self-monitoring of BP and weight twice monthly continues via the text platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic changes from baseline to 12 weeks and 24 weeks | systolic and diastolic blood pressure | Baseline, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight changes from baseline to 12 weeks and 24 weeks | Change in BMI | Baseline, 12 weeks and 24 weeks |
| Diet quality changes from baseline to 12 weeks and 24 weeks | Change in DASH score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mile Square Health Center Chicago | Not yet recruiting | Chicago | Illinois | 60608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37712088 | Background | Ferdinand DP, Reddy TK, Wegener MR, Guduri PS, Lefante JJ, Nedunchezhian S, Ferdinand KC. TEXT MY BP MEDS NOLA: A pilot study of text-messaging and social support to increase hypertension medication adherence. Am Heart J Plus. 2023 Feb;26:100253. doi: 10.1016/j.ahjo.2023.100253. Epub 2023 Jan 13. | |
| Background | Mile Square Health Center Locations. Accessed September 4, 2025. //hospital.uillinois.edu/mile-square-health-center/locations | ||
| 32330233 |
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| FIM Usual Care Arm | Combination Product | FIM Usual care arm (control) receives usual clinical care during the 24-week period, with limited study contact outside scheduled data-collection visits; after completing all study visits, control participants receive the post-study materials |
|
| Baseline,12 weeks and 24 weeks |
| Waist circumference changes from baseline to 12 weeks and 24 weeks | Change in Waist circumference | Baseline,12 weeks and 24 weeks |
| Mile Square Health Center - Auburn Gresham | Not yet recruiting | Chicago | Illinois | 60620 | United States |
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| Mile Square Health Center - Englewood | Not yet recruiting | Chicago | Illinois | 60621 | United States |
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| Mile Square Health Center - South Shore | Recruiting | Chicago | Illinois | 60649 | United States |
|
| Background |
| Filippou CD, Tsioufis CP, Thomopoulos CG, Mihas CC, Dimitriadis KS, Sotiropoulou LI, Chrysochoou CA, Nihoyannopoulos PI, Tousoulis DM. Dietary Approaches to Stop Hypertension (DASH) Diet and Blood Pressure Reduction in Adults with and without Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2020 Sep 1;11(5):1150-1160. doi: 10.1093/advances/nmaa041. |
| 32487290 | Background | Ostchega Y, Fryar CD, Nwankwo T, Nguyen DT. Hypertension Prevalence Among Adults Aged 18 and Over: United States, 2017-2018. NCHS Data Brief. 2020 Apr;(364):1-8. |
| 36456831 | Result | Steen DL, Helsley RN, Bhatt DL, King EC, Summer SS, Fenchel M, Saelens BE, Eckman MH, Couch SC. Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. Nat Med. 2022 Dec;28(12):2530-2536. doi: 10.1038/s41591-022-02077-7. Epub 2022 Dec 1. |
| 36830853 | Result | Konikowska K, Bombala W, Szuba A, Rozanska D, Regulska-Ilow B. A High-Quality Diet, as Measured by the DASH Score, Is Associated with a Lower Risk of Metabolic Syndrome and Visceral Obesity. Biomedicines. 2023 Jan 23;11(2):317. doi: 10.3390/biomedicines11020317. |
| 9099655 | Result | Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601. |
| 23000025 | Result | Epstein DE, Sherwood A, Smith PJ, Craighead L, Caccia C, Lin PH, Babyak MA, Johnson JJ, Hinderliter A, Blumenthal JA. Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. J Acad Nutr Diet. 2012 Nov;112(11):1763-73. doi: 10.1016/j.jand.2012.07.007. Epub 2012 Sep 19. |
| 30288401 | Result | Olomu A, Khan NNS, Todem D, Huang Q, Bottu S, Qadri S, Holmes-Rovner M. Blood Pressure Control in Hypertensive Patients in Federally Qualified Health Centers: Impact of Shared Decision Making in the Office-GAP Program. MDM Policy Pract. 2016 Jul 7;1(1):2381468316656010. doi: 10.1177/2381468316656010. eCollection 2016 Jul-Dec. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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