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Healthy Diet Intervention for High Blood Pressure (HFF Trial)

N/A
Waitlist Available
Led By Darren DeWalt, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of hypertension with systolic blood pressure > 130 mm Hg
English or Spanish speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

HFF Trial Summary

This trial will compare two interventions to help with food insecurity, which is a major reason for poor blood pressure control and hypertension complications.

Who is the study for?
This trial is for English or Spanish speakers over 18 living within the delivery area, who experience food insecurity and have high blood pressure (systolic >130 mm Hg). It's not for those with cancer, pregnant women, or individuals with advanced kidney disease.Check my eligibility
What is being tested?
The study tests if a healthy food subsidy or delivered food box can improve blood pressure in people facing challenges to eating healthily due to socioeconomic factors. Participants will also receive lifestyle support from community health workers for either 6 or 12 months.See study design
What are the potential side effects?
Since this trial involves dietary changes and lifestyle support rather than medication, side effects are minimal but may include initial discomfort adjusting to new foods or changes in digestion as one adapts to the Mediterranean diet.

HFF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with high blood pressure above 130 mm Hg.
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I speak English or Spanish.
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I am 18 years old or older.

HFF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Office-based Diastolic Blood Pressure at Month 12
Office-based Diastolic Blood Pressure at Month 18
Office-based Diastolic Blood Pressure at Month 6
+3 more
Secondary outcome measures
Ambulatory Diastolic Blood Pressure at Month 12
Ambulatory Diastolic Blood Pressure at Month 18
Ambulatory Diastolic Blood Pressure at Month 6
+25 more

HFF Trial Design

8Treatment groups
Experimental Treatment
Group I: Food subsidy, with lifestyle support, 6 monthsExperimental Treatment2 Interventions
Participants will receive food subsidy and healthy lifestyle support for 6 months.
Group II: Food subsidy, with lifestyle support, 12 monthsExperimental Treatment2 Interventions
Participant will receive food subsidy and lifestyle support for 12 months.
Group III: Food subsidy, no lifestyle support, 6 monthsExperimental Treatment1 Intervention
Participant will receive $40 healthy food subsidy for 6 months.
Group IV: Food subsidy, no lifestyle support, 12 monthsExperimental Treatment1 Intervention
Participants will receive food subsidy for 12 months.
Group V: Food delivery, with lifestyle support, 6 monthsExperimental Treatment2 Interventions
Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.
Group VI: Food delivery, with lifestyle support, 12 monthsExperimental Treatment2 Interventions
Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.
Group VII: Food delivery, no lifestyle support, 6 monthsExperimental Treatment1 Intervention
Participant will receive twice monthly healthy food delivery for 6 months.
Group VIII: Food delivery, no lifestyle support, 12 monthsExperimental Treatment1 Intervention
Participants will receive twice monthly food box deliveries for 12 months.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,498 Previous Clinical Trials
4,175,672 Total Patients Enrolled
Duke UniversityOTHER
2,351 Previous Clinical Trials
3,409,006 Total Patients Enrolled
Blue Cross Blue Shield of North CarolinaUNKNOWN

Media Library

Food Delivery Clinical Trial Eligibility Overview. Trial Name: NCT05048836 — N/A
High Blood Pressure Research Study Groups: Food subsidy, no lifestyle support, 12 months, Food subsidy, with lifestyle support, 12 months, Food delivery, with lifestyle support, 12 months, Food delivery, no lifestyle support, 12 months, Food subsidy, with lifestyle support, 6 months, Food delivery, with lifestyle support, 6 months, Food delivery, no lifestyle support, 6 months, Food subsidy, no lifestyle support, 6 months
High Blood Pressure Clinical Trial 2023: Food Delivery Highlights & Side Effects. Trial Name: NCT05048836 — N/A
Food Delivery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048836 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this research endeavor?

"This clinical trial's primary metric for success is the Office-Based Systolic Blood Pressure at Month 6. Secondary goals include assessing Diet Quality using the Brief Dietary Assessment Scale, which comprises of three subscales; Vegetables, Fruit, Whole Grains and Beans (0 - 20), Drinks, Desserts, Snacks Eating Out and Salt (0 - 20) as well as Fish Meat Poultry Dairy and Eggs (0 - 10). Additionally Combined Systolic Blood Pressure measurements taken both in a healthcare setting or outside one will be monitored at Month 12 while Ambulatory Diastolic Blood Pressure readings taken beyond a medical centre also"

Answered by AI

Does this clinical trial encompass those aged eighty-five and above?

"This research is recruiting participants who are between the age of 18 and 99."

Answered by AI

To whom is this investigation open?

"This investigation is looking for 1400 individuals, aged 18 to 99 years old, who suffer hypertension. Furthermore, they must be within the delivery area of the necessary intervention services and fit inside the specified age range."

Answered by AI

Are there presently opportunities to enroll in this research project?

"The research posted on clinicaltrials.gov reveals that, since November 1st 2022, this trial is no longer actively enrolling patients. Despite the closure of recruitment for this study, 765 other medical studies are still looking to welcome participants."

Answered by AI
~35 spots leftby Jun 2024