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

Primary Purpose

Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and vegetable supplement
Dietary and chronic disease management education
Sponsored by
St. Catherine University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring carotenoids, cardiovascular disease, medically-tailored food kit, Hispanic/Latinx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M Health Fairview Clinic
  • Church of St. WilliamRecruiting
  • Park Avenue United Methodist Church
  • St. Catherine University
  • St. Matthew's Parish Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
St. Catherine University
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05802134
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Catherine University
Collaborators
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
carotenoids, cardiovascular disease, medically-tailored food kit, Hispanic/Latinx

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fruit and vegetable supplement
Intervention Description
Weekly food kits including culturally-appropriate fruits and vegetables (to achieve 8-10 servings per day) and staple items to support DASH diet compliance
Intervention Type
Behavioral
Intervention Name(s)
Dietary and chronic disease management education
Intervention Description
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)
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
measure the change in systolic blood pressure while following DASH Diet fruit and vegetable requirements
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Diastolic Blood Pressure
Description
measure the change in diastolic blood pressure while following DASH Diet fruit and vegetable requirements
Time Frame
1 month
Title
Skin carotenoid status
Description
measure the change in serum carotenoid status using skin spectrometry while following DASH Diet fruit and vegetable requirements
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ambria C Crusan, PhD
Phone
651-690-6695
Email
accrusan685@stkate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambria C Crusan, PhD
Organizational Affiliation
St. Catherine University
Official's Role
Principal Investigator
Facility Information:
Facility Name
M Health Fairview Clinic
City
Apple Valley
State/Province
Minnesota
ZIP/Postal Code
55124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Backberg
Phone
651-287-7755
Email
kbackberg@stmarysclinics.org
Facility Name
Church of St. William
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Backberg
Phone
651-287-7755
Email
kbackberg@stmarysclinics.org
Facility Name
Park Avenue United Methodist Church
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Martinez
Phone
651-287-7727
Email
kmartinez@stmarysclinics.org
Facility Name
St. Catherine University
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Camacho
Phone
651-287-7748
Email
scamacho@stmarysclinics.org
Facility Name
St. Matthew's Parish Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Camacho
Phone
651-287-7748
Email
scamacho@stmarysclinics.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
background
PubMed Identifier
26718414
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.
Results Reference
background
PubMed Identifier
34209048
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.
Results Reference
background
PubMed Identifier
33358716
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
30764511
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.
Results Reference
background
PubMed Identifier
25008856
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.
Results Reference
background
PubMed Identifier
28993451
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.
Results Reference
background
Links:
URL
https://www.nhlbi.nih.gov/education/dash-eating-plan
Description
DASH Eating Plan
URL
https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html
Description
NIMHD Research Framework

Learn more about this trial

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

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