NCT07332741

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
50mo left

Started May 2026

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
May 2026Sep 2030

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 22, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

July 10, 2026

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

December 30, 2025

Last Update Submit

July 8, 2026

Conditions

HypertensionHypertension (HTN)Obesity & Overweight

Keywords

Food is MedicineHypertensionObesityNutrition

Outcome Measures

Primary Outcomes (1)

  • Systolic and diastolic changes from baseline to 12 weeks and 24 weeks

    systolic and diastolic blood pressure

    Baseline, 12 weeks and 24 weeks

Secondary Outcomes (3)

  • Weight changes from baseline to 12 weeks and 24 weeks

    Baseline, 12 weeks and 24 weeks

  • Diet quality changes from baseline to 12 weeks and 24 weeks

    Baseline,12 weeks and 24 weeks

  • Waist circumference changes from baseline to 12 weeks and 24 weeks

    Baseline,12 weeks and 24 weeks

Study Arms (2)

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.

Combination Product: FIM Usual Care Arm

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.

Combination Product: FIM intervention arm

Interventions

FIM Usual Care ArmCOMBINATION_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 armCOMBINATION_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

Sexall
Healthy VolunteersNo
Age GroupsChild (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mile Square Health Center Chicago

Chicago, Illinois, 60608, United States

NOT YET RECRUITING

Mile Square Health Center - Auburn Gresham

Chicago, Illinois, 60620, United States

NOT YET RECRUITING

Mile Square Health Center - Englewood

Chicago, Illinois, 60621, United States

NOT YET RECRUITING

Mile Square Health Center - South Shore

Chicago, Illinois, 60649, United States

RECRUITING

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: 37712088BACKGROUND

  • 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: 32330233BACKGROUND

  • 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: 32487290BACKGROUND

  • 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: 36456831RESULT

  • 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: 36830853RESULT

  • 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: 9099655RESULT

  • 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: 23000025RESULT

  • 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: 30288401RESULT

MeSH Terms

Conditions

HypertensionObesityOverweight

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological 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

May 22, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

July 10, 2026

Record last verified: 2025-09

Locations

US(4)