FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control

NCT07332741 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-0974
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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?

Conditions

Hypertension; Hypertension (HTN); Obesity & Overweight

Keywords

Food is Medicine; Hypertension; Obesity; Nutrition

Outcome Measures

Primary Outcomes (1)

• blood pressure

  systolic and diastolic blood pressure

  From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase)

Secondary Outcomes (3)

• Weight management

  From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase)

• DASH diet adherence score

  From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase)

• Waist circumference

  From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase)

Study Arms (2)

FIM Usual Care Arm

ACTIVE COMPARATOR

Combination Product: FIM Usual Care Arm

FIM Intervention Arm

EXPERIMENTAL

Combination Product: FIM intervention arm

Interventions

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

FIM Usual Care Arm

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.

FIM Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• inability to speak/read English; cognitive impairment that precludes informed consent or participation; severe food allergies or medically necessary dietary restrictions that would preclude adoption of a DASH eating pattern; inability to cook at home; current treatment for cancer; self-reported history of a recent major cardiovascular event within the past 12 months (myocardial infarction, cerebrovascular accident, cardiac surgery, or hypertensive emergency); known advanced liver or renal disease; severe mental illness that would preclude participation; pregnancy. Individuals with lactose intolerance will not be excluded because low-lactose alternatives are available within the intervention.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (4)

Miles Square Health Center Chicago

Chicago, Illinois, 60608, United States

Location

Miles Square Health Center - Auburn Gresham

Chicago, Illinois, 60620, United States

Location

Miles Square Health Center - Englewood

Chicago, Illinois, 60621, United States

Location

Miles Square Health Center - South Shore

Chicago, Illinois, 60649, United States

Location

Related Publications (9)

• 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.

  PMID: 37712088 BACKGROUND

• Mile Square Health Center Locations. Accessed September 4, 2025. //hospital.uillinois.edu/mile-square-health-center/locations

  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.

  PMID: 32330233 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.

  PMID: 32487290 BACKGROUND

• 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.

  PMID: 36456831 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.

  PMID: 36830853 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.

  PMID: 9099655 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.

  PMID: 23000025 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.

  PMID: 30288401 RESULT

MeSH Terms

Conditions

Hypertension; Obesity; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2025-09

Locations

US (4)