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

Обзор

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?

Подробное описание

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.

Вмешательства

• Комбинированный продукт FIM intervention arm
  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. Part
• Комбинированный продукт FIM Usual Care Arm
  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

Первичные конечные точки

• Systolic and diastolic changes from baseline to 12 weeks and 24 weeks [Срок оценки: Baseline, 12 weeks and 24 weeks]

Вторичные конечные точки (3)

• Weight changes from baseline to 12 weeks and 24 weeks [Срок оценки: Baseline, 12 weeks and 24 weeks]
• Diet quality changes from baseline to 12 weeks and 24 weeks [Срок оценки: Baseline,12 weeks and 24 weeks]
• Waist circumference changes from baseline to 12 weeks and 24 weeks [Срок оценки: Baseline,12 weeks and 24 weeks]

Критерии участия

Критерии включения

• Adults aged ≥18 years; diagnosis of hypertension in Electronic health record or most recent clinic blood pressure meeting inclusion thresholds (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥80 mmHg); BMI ≥30 kg/m²; able and willing to complete survey instruments and assessment procedures; able to speak/read English; access to a smartphone with text-messaging capability.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• Mile Square Health Center Chicago — Chicago
• Mile Square Health Center - Auburn Gresham — Chicago
• Mile Square Health Center - Englewood — Chicago
• Mile Square Health Center - South Shore — Chicago

Публикации

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

Идентификаторы

NCT: NCT07332741 · 2025-0974

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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