Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes (DASH-Life)

Johns Hopkins University

Status

Enrolling

Conditions

Hypertension

Type 2 Diabetes Mellitus (T2DM)

Treatments

Behavioral: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention

Behavioral: Self-Shopping DASH diet advice

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06921356

IRB00425074

P50MD017348 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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