Clinical trial NCT05802134: Increased Access to Fruits and Vegetables for Hypertension in Immigrant Hispanic/Latinx Individuals
Official title: Increased Access to Fruits and Vegetables for DASH Diet Compliance in Immigrant Hispanic/Latinx Individuals With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: carotenoids
cardiovascular disease
medically-tailored food kit
Hispanic/Latinx
Lead sponsor: St. Catherine University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2023-04-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this observational study is to learn about the effect improved access to culturally-appropriate fruits/vegetables has on cardiometabolic markers, specifically systolic blood pressure and markers of adiposity in immigrant Hispanic/Latinx individuals with hypertension and obesity. The secondary aim is to determine compliance to the increased F/V intake recommended by the Dietary Approaches to Stop Hypertension (DASH) Diet by assessing changes in skin carotenoid status. The main question it aims to answer is whether consuming 8-10 servings of culturally-appropriate, carotenoid-containing F/V daily for 4 weeks to meet the requirements of the DASH Diet supported by diet and lifestyle education will result in reductions in systolic BP and decreased markers of adiposity (body weight, Body Mass Index, and waist circumference).

Detailed description: This study will utilize a phased, mixed methods approach including a literature review to inform a patient/provider survey, individual patient interviews to better understand how to develop a medically-tailored foods box for the patient population with hypertension, and an open observational study.

The proposed study will be conducted at a St. Mary's Health Clinics site in the Twin Cities metro, which includes access to the required equipment, a space to collect required measures, and designated patient rooms for participant privacy. Obese (BMI \>30 kg/m2) men and women (ages 18+) diagnosed with hypertension will be recruited via flyers, email, and mail from St. Mary's Health Clinics for an open observational study. For 4 weeks, the individuals will receive supplemental, culturally-appropriate fruits and vegetables (to achieve 8-10 servings per day) supported by intensive education for chronic disease management. To address social determinants of health surrounding fruit and vegetable access, food will be provided for the patient and family members, if the participant indicates a need.

Participants will receive supplemental fruits and vegetables high in carotenoids and staple items that are promoted on a DASH Diet, with encouragement and support to consume the fruits and vegetables via recipes, samples, and weekly text/call check-ins to support utilization. Compliance will be measured via non-invasive skin carotenoid status using a Veggiemeter. Boxes will be distributed from a central site, similar to the medication pick-up structure St. Mary's Health Clinics patients are familiar with or will be delivered to the patient's preferred address, if access to the clinic is a barrier. All enrolled participants will receive education on hypertension management, which will include an interprofessional health appointment with a medical professional to discuss medication compliance, and resources from an occupational therapist for chronic disease management strategies, and 2 nutrition appointments with a Registered Dietitian regarding the DASH Diet (initial education and follow-up at 2 weeks). The interprofessional education provided is intended to yield in higher compliance to dietary changes and adherence to medication regimen. All materials and appointments will be available in Spanish and English. There will be an interpreter available for all medical appointments, as 85% of patients are non-English speaking.

All participants will be screened to ensure eligibility. Screening will include: a demographic (age, gender, race/ethnicity, smoking status, family size, and primary food preparer in the household) and medical history questionnaire to determine comorbidities. The National Cancer Institute's 19-item F/V screener will be utilized to determine regular consumption of F/V for the participant and the family, if applicable. Exclusions will be made for individuals that are taking insulin to manage diabetes mellitus, smokers, and those with a BMI \<30 kg/m2. At baseline (day 0) and Day 28, cardiometabolic markers (height, weight, BP, waist circumference, and skin carotenoid status) will be collected. BP will be measured by trained professionals using random- zero sphygmomanometers while sitting down after a 5-minute rest period. Two measures will be collected and averaged. Carotenoid status will be assessed via non-invasive skin spectrometry using a VeggieMeter (Longevity Link Corporation, UT). The quantity of F/V provided in the supplemental box to achieve 8-10 servings daily will be determined during the screening.

Eligibility criteria: Inclusion Criteria:

* self-identified Hispanic/Latinx individuals
* patients at the St. Mary's Health Clinic
* hypertension diagnosis
* obese (BMI \>30 kg/m2)

Exclusion Criteria:

* current smokers
* individuals taking insulin to manage diabetes mellitus
* individuals with a BMI \<30 kg/m2

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 month
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 1 month
measure: Skin carotenoid status
timeFrame: 1 month
Other outcomes:
Locations:
city: Apple Valley
country: United States
facility: M Health Fairview Clinic
state: Minnesota
city: Fridley
country: United States
facility: Church of St. William
state: Minnesota
city: Minneapolis
country: United States
facility: Park Avenue United Methodist Church
state: Minnesota
city: Saint Paul
country: United States
facility: St. Catherine University
state: Minnesota
city: Saint Paul
country: United States
facility: St. Matthew's Parish Center
state: Minnesota
Study officials:
affiliation: St. Catherine University
name: Ambria C Crusan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Institute of Health. Eating At America's Table Study Quick Food Scan. Published online 2000. https://snaped.fns.usda.gov/library/materials/national-cancer-institute-nci-fruit-vegetable-intake-screeners-eating-americas-0
citation: Chiu S, Bergeron N, Williams PT, Bray GA, Sutherland B, Krauss RM. Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Am J Clin Nutr. 2016 Feb;103(2):341-7. doi: 10.3945/ajcn.115.123281. Epub 2015 Dec 30.
citation: Di Noia J, Gellermann W. Use of the Spectroscopy-Based Veggie Meter(R) to Objectively Assess Fruit and Vegetable Intake in Low-Income Adults. Nutrients. 2021 Jun 30;13(7):2270. doi: 10.3390/nu13072270.
citation: Toh DWK, Sutanto CN, Loh WW, Lee WY, Yao Y, Ong CN, Kim JE. Skin carotenoids status as a potential surrogate marker for cardiovascular disease risk determination in middle-aged and older adults. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):592-601. doi: 10.1016/j.numecd.2020.10.016. Epub 2020 Oct 26.
citation: USDA. Food Security Survey Module: Six-Item Short Form. Published 2012. https://snaped.fns.usda.gov/library/materials/food-security-survey-module-six-item-short-form
citation: Chiavaroli L, Viguiliouk E, Nishi SK, Blanco Mejia S, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CW, Sievenpiper JL. DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. Nutrients. 2019 Feb 5;11(2):338. doi: 10.3390/nu11020338.
citation: Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.
citation: Juraschek SP, Woodward M, Sacks FM, Carey VJ, Miller ER 3rd, Appel LJ. Time Course of Change in Blood Pressure From Sodium Reduction and the DASH Diet. Hypertension. 2017 Nov;70(5):923-929. doi: 10.1161/HYPERTENSIONAHA.117.10017.