RECRUITING

Groceries for Residents of Southeastern USA to Stop Hypertension

Conditions

Hypertension Elevated Blood Pressure Cardiovascular Diseases Dietary Intervention Dash Diet Low Sodium Diet Nutrition Clinical trial Dietitian

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Official Title

Groceries for Residents of Southeastern USA to Stop Hypertension

Quick Facts

Study Start:2025-08

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06891911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Resting systolic blood pressure of 120 to \<160 mm Hg and diastolic blood pressure \<110 mm Hg 2. Resident of Florida, Georgia, and Tennessee 3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period 4. Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service 5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages 6. Willing and able to complete required measurement procedures 7. Able to provide consent for the study 8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study	1. Serum potassium ≥5.0 mmol/L or \<3.5 mmol/L 2. Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 3. Hemoglobin A1c ≥6.5% 1. GLP-1 and dual GLP-1/GIP receptor agonists 2. Anti-hypertension medications 3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors 4. Glucose lowering medications 1. Potassium supplement, except if part of a multivitamin 2. Warfarin (Coumadin) 3. Chronic oral corticosteroid (intermittent use is okay) 4. Weight loss medications (non-GLP-1 receptor agonists) 5. Sulfonylurea or any insulin use 1. Systolic blood pressure: \<120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg 2. Arm circumference \>52 cm (or the upper limit of the validated BP device) 1. Self-reported weight loss or gain of 15 pounds during prior 2 months 2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission 3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable) 4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence 5. Pregnancy or lactation or planned pregnancy during the study period 6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months 7. Hypoglycemia hospitalization in the last 12 months 8. Any other serious illness or condition not compatible with participation as determined by the investigators 1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence 2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week 3. Active substance use disorder that would interfere with participation 4. Extreme food insecurity 5. Participation in or planning to start weight loss program 6. Current participation in another clinical trial that could interfere with the study protocol 7. Anticipated change in residence outside of eligible states prior to the end of the study 8. Families with more than 6 adults at dinner time (children count as half an adult)

Inclusion Criteria

Exclusion Criteria

1. Resting systolic blood pressure of 120 to \<160 mm Hg and diastolic blood pressure \<110 mm Hg
2. Resident of Florida, Georgia, and Tennessee
3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period
4. Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service
5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages
6. Willing and able to complete required measurement procedures
7. Able to provide consent for the study
8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study

1. Serum potassium ≥5.0 mmol/L or \<3.5 mmol/L
2. Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
3. Hemoglobin A1c ≥6.5%
1. GLP-1 and dual GLP-1/GIP receptor agonists
2. Anti-hypertension medications
3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors
4. Glucose lowering medications
1. Potassium supplement, except if part of a multivitamin
2. Warfarin (Coumadin)
3. Chronic oral corticosteroid (intermittent use is okay)
4. Weight loss medications (non-GLP-1 receptor agonists)
5. Sulfonylurea or any insulin use
1. Systolic blood pressure: \<120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
2. Arm circumference \>52 cm (or the upper limit of the validated BP device)
1. Self-reported weight loss or gain of 15 pounds during prior 2 months
2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission
3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable)
4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
5. Pregnancy or lactation or planned pregnancy during the study period
6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
7. Hypoglycemia hospitalization in the last 12 months
8. Any other serious illness or condition not compatible with participation as determined by the investigators
1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
3. Active substance use disorder that would interfere with participation
4. Extreme food insecurity
5. Participation in or planning to start weight loss program
6. Current participation in another clinical trial that could interfere with the study protocol
7. Anticipated change in residence outside of eligible states prior to the end of the study
8. Families with more than 6 adults at dinner time (children count as half an adult)

Contacts and Locations

Study Contact

Stephen P. Juraschek, MD, PhD

CONTACT

6177541416

sjurasch@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Hypertension
Dash Diet
Low Sodium
Diet
Nutrition
Clinical trial
Dietitian

Additional Relevant MeSH Terms

Hypertension
Elevated Blood Pressure
Cardiovascular Diseases
Dietary Intervention