Increased Access to Fruits and Vegetables for Hypertension in Immigrant Hispanic/Latinx Individuals

Sponsor

St. Catherine University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05802134

Collaborator

University of Minnesota (Other)

Enrollment

Locations

Arm

13.1

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Dietary Supplement: Fruit and vegetable supplement Behavioral: Dietary and chronic disease management education	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 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.	Dietary Supplement: Fruit and vegetable supplement Weekly food kits including culturally-appropriate fruits and vegetables (to achieve 8-10 servings per day) and staple items to support DASH diet compliance Behavioral: Dietary and chronic disease management education Intensive education for chronic disease management: 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)

Arm

Intervention/Treatment

Experimental: Experimental

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.

Dietary Supplement: Fruit and vegetable supplement

Weekly food kits including culturally-appropriate fruits and vegetables (to achieve 8-10 servings per day) and staple items to support DASH diet compliance

Behavioral: Dietary and chronic disease management education

Intensive education for chronic disease management: 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)

Outcome Measures

Primary Outcome Measures

Systolic Blood Pressure [1 month]
measure the change in systolic blood pressure while following DASH Diet fruit and vegetable requirements

Secondary Outcome Measures

Diastolic Blood Pressure [1 month]
measure the change in diastolic blood pressure while following DASH Diet fruit and vegetable requirements
Skin carotenoid status [1 month]
measure the change in serum carotenoid status using skin spectrometry while following DASH Diet fruit and vegetable requirements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M Health Fairview Clinic	Apple Valley	Minnesota	United States	55124
2	Church of St. William	Fridley	Minnesota	United States	55432
3	Park Avenue United Methodist Church	Minneapolis	Minnesota	United States	55407
4	St. Catherine University	Saint Paul	Minnesota	United States	55105
5	St. Matthew's Parish Center	Saint Paul	Minnesota	United States	55107