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

NCT05802134 | Completed DMC

• 1 other identifier: 1744
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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).

Conditions

Cardiovascular Diseases

Keywords

carotenoids; cardiovascular disease; medically-tailored food kit; Hispanic/Latinx

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

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

  1 month

Secondary Outcomes (2)

• Diastolic Blood Pressure

  1 month

• Skin carotenoid status

  1 month

Study Arms (1)

Fruit and Vegetable recipient

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; Behavioral: Dietary and chronic disease management education

Interventions

Fruit and vegetable supplement DIETARY_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

Fruit and Vegetable recipient

Dietary and chronic disease management education BEHAVIORAL

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)

Fruit and Vegetable recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Catherine University: lead
• University of Minnesota: collaborator

Study Sites (5)

M Health Fairview Clinic

Apple Valley, Minnesota, 55124, United States

Location

Church of St. William

Fridley, Minnesota, 55432, United States

Location

Park Avenue United Methodist Church

Minneapolis, Minnesota, 55407, United States

Location

St. Catherine University

Saint Paul, Minnesota, 55105, United States

Location

St. Matthew's Parish Center

Saint Paul, Minnesota, 55107, United States

Location

Related Publications (9)

• 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

  BACKGROUND

• 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.

  PMID: 26718414 BACKGROUND

• 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.

  PMID: 34209048 BACKGROUND

• 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.

  PMID: 33358716 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30764511 BACKGROUND

• 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.

  PMID: 25008856 BACKGROUND

• 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.

  PMID: 28993451 BACKGROUND

• Crusan A, Roozen KL, Godoy-Henderson C, Evans A, Reeves K. Developing and evaluating a culturally-appropriate food kit for increased access to fruits and vegetables and DASH eating plan alignment in immigrant Hispanic/Latine individuals with hypertension: a pilot study. BMC Nutr. 2025 May 16;11(1):97. doi: 10.1186/s40795-025-01089-z.

  PMID: 40380253 DERIVED

Related Links

• DASH Eating Plan
• NIMHD Research Framework

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fruit; Diet

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena

Study Officials

• Ambria C Crusan, PhD

  St. Catherine University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: March 28, 2023
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)