CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Fruit and vegetable supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05802134
NCT05802134N/ACompleted

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

St. Catherine University·interventional·Posted Apr 6, 2023·Updated Mar 28, 2024

In Brief

A clinical study evaluating Fruit and vegetable supplement and Dietary and chronic disease management education for Cardiovascular Diseases. Completed, enrolled 21 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedApr 6, 2023
Enrollment StartMar 28, 2023
Primary CompletionSep 7, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.2 years ago

Interventions

Fruit and vegetable supplementdietary

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

Dietary and chronic disease management educationbehavioral

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)