Healthy Eating Program for Adults with High Blood Pressure and Diabetes
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes Residing in Urban Food Deserts (DASH-Life): Pilot Randomized Clinical Trial
This study is testing whether a healthy eating program can help adults with high blood pressure and diabetes lower their blood pressure and blood sugar levels by improving their diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06921356 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a multi-component lifestyle intervention aimed at improving dietary habits among adults with hypertension and type 2 diabetes. Participants will receive either self-shopping diet advice or coaching on the DASH diet, focusing on increasing the intake of fresh fruits and vegetables. The study will take place over six months in Baltimore metro areas identified as having limited access to healthy food options. The goal is to determine if these dietary changes can effectively lower blood pressure and blood sugar levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes and hypertension living in designated low-access food areas in Baltimore.
Not a fit: Patients with recent cardiovascular events or those on specific diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for patients with hypertension and type 2 diabetes by promoting better dietary habits.
How similar studies have performed: Previous studies have shown positive outcomes with dietary interventions for similar conditions, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c\>=6.5%, or treatment of diabetes with diabetes medications(s) * Baseline systolic BP 120-159 mmHg (with or without medications.) * Serum potassium level \>3.0 and \<5 mmol/L, * Estimated glomerular filtration rate (eGFR) \>=45 mL/min/1.73m2. * Willing and able to complete required procedures in English. * Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile\>=6.) Exclusion Criteria: * Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months * Cardiovascular event within 6 months * On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications * HbA1c ≥ 10% * Type 1 diabetes * Baseline systolic BP \< 100 mmHg * Weight \>400 lbs due to the maximum weight on study scale * Chronic disease that might interfere with trial participation * Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures * Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets) * Unwillingness or inability to adopt a DASH-like diet * Planning to leave area in the next 6 months
Where this trial is running
Baltimore, Maryland
- Johns Hopkins ProHealth Clinical Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Yeh, PhD — Johns Hopkins University
- Study coordinator: Jessica Yeh, PhD
- Email: hyeh1@jhmi.edu
- Phone: 410-614-4316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.