Your session is about to expire
← Back to Search
Nutritional Support for High Blood Pressure (SMART-FI Trial)
N/A
Waitlist Available
Led By Deepak Palakshappa, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients (≥18 years of age) with a diagnosis of Hypertension (HTN) (defined by ICD-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
SMART-FI Trial Summary
This trial found 47% of US adults have high blood pressure, which is linked to more deaths from heart disease than any other risk factor. A new method of treatment is needed to help this large, vulnerable population.
Who is the study for?
This trial is for adults in Winston-Salem or Forsyth County with high blood pressure (>130/80) and food insecurity. Participants must have a hypertension diagnosis or be on blood pressure meds, but can't join if they're pregnant, planning to move soon, have severe cognitive issues, lack stable housing for meal storage, suffer from advanced kidney disease or other serious conditions limiting life expectancy.Check my eligibility
What is being tested?
The SMART-FI trial is testing whether providing resources like SNAP benefits and medically tailored meals along with the support of community health workers can help manage high blood pressure in patients who struggle with getting enough food.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as nutritional assistance and education rather than drugs or medical procedures, there are no direct side effects associated with typical clinical trials. However, changes in diet may affect individuals differently.
SMART-FI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with high blood pressure or taking medication for it.
SMART-FI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Pressure Readings
Feasibility of recruitment Percentage
Feasibility of retention Percentage
SMART-FI Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: resource referralExperimental Treatment1 Intervention
will receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address Food Insecurities (FI) Supplemental Nutrition Assistance Program (SNAP).
Group II: community health worker (CHW) interventionActive Control1 Intervention
assist participants in addressing FI and supporting them in their blood pressure management
Group III: medically tailored meals (MTM)Active Control1 Intervention
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,143 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,548 Total Patients Enrolled
Deepak Palakshappa, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe mental health issues that prevent me from understanding or agreeing to participate.My kidney function is severely reduced.I cannot communicate in English or Spanish.I am 18 or older with high blood pressure or taking medication for it.Your blood pressure at your regular doctor's office was higher than 130/80.I do not have a stable place to live or a way to store food safely.I have a serious health condition that needs ongoing treatment.You do not have a phone.You have difficulty getting enough food to eat, as indicated by a specific questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: resource referral
- Group 2: community health worker (CHW) intervention
- Group 3: medically tailored meals (MTM)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research effort available for participation at the present moment?
"Clinicaltrials.gov indicates that this medical trial is no longer enrolling participants, despite first being posted on May 1st 2023 and last updated on April 4th 2023. Nevertheless, there are 741 other clinical trials actively recruiting patients at the present time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger