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临床试验/NCT05802134
NCT05802134已完成不适用

Increased Access to Fruits and Vegetables for DASH Diet Compliance in Immigrant Hispanic/Latinx Individuals With Hypertension

St. Catherine University10 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
10
主要终点
Systolic Blood Pressure

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Systolic Blood Pressure

时间窗: 1 month

measure the change in systolic blood pressure while following DASH Diet fruit and vegetable requirements

次要结局

  • Diastolic Blood Pressure(1 month)
  • Skin carotenoid status(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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