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Fruits & Vegetables + Education for High Blood Pressure
N/A
Waitlist Available
Led By Ambria C Crusan, PhD
Research Sponsored by St. Catherine University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Obese (BMI >30 kg/m2)
Hypertension diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial aims to find out if improved access to culturally-appropriate fruits/veggies can help lower blood pressure & reduce obesity in Hispanic/Latinx immigrants.
Who is the study for?
This trial is for obese Hispanic/Latinx individuals with high blood pressure, who are patients at St. Mary's Health Clinic. Participants should have a BMI over 30 and not be current smokers or taking insulin for diabetes.Check my eligibility
What is being tested?
The study tests if eating 8-10 servings of culturally-appropriate fruits/vegetables daily, along with diet education based on the DASH Diet, can lower blood pressure and reduce body weight in participants after four weeks.See study design
What are the potential side effects?
Since this intervention involves dietary changes to include more fruits and vegetables, side effects are minimal but may include digestive adjustments as the body adapts to increased fiber intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 30.
Select...
I have been diagnosed with high blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systolic Blood Pressure
Secondary outcome measures
Diastolic Blood Pressure
Skin carotenoid status
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fruit and Vegetable recipientExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruit and vegetable supplement
2023
N/A
~30
Dietary and chronic disease management education
2023
N/A
~30
Find a Location
Who is running the clinical trial?
St. Catherine UniversityLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
University of MinnesotaOTHER
1,389 Previous Clinical Trials
1,553,066 Total Patients Enrolled
Ambria C Crusan, PhDPrincipal InvestigatorSt. Catherine University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is over 30.You are currently smoking.You are not overweight.I manage my diabetes with insulin.I have been diagnosed with high blood pressure.People who identify as Hispanic/Latinx.
Research Study Groups:
This trial has the following groups:- Group 1: Fruit and Vegetable recipient
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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