Recruiting

Lifestyle Intervention

Sponsor:

Johns Hopkins University

Code:

NCT06921356

Conditions

Hypertension

Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention

Self-Shopping DASH diet advice

Study Details

Brief summary:

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.

Conditions

Hypertension

Type 2 Diabetes Mellitus (T2DM)

Study ID

NCT06921356

Start date

May 15, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Self-Shopping DASH diet advice group (S-DASH)

experimental: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)

Interventions

Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention

Participants assigned to the C-DASH group will meet by telephone with the study coach for 1 hour, and then have brief weekly conversations (about 15-30 minutes) by phone during the first three months. During these weekly calls, the study coach will assist participant with selecting fruits, vegetables, nuts, and beans. During months 4-6, the study coach will continue to work with participant to set goals for following the DASH-Life way of eating, but the study will no longer provide a weekly food allowance to purchase groceries.

Self-Shopping DASH diet advice

Participants assigned to the S-DASH group will receive a brochure about the DASH eating plan. For the first three months, Participants will also receive a gift card to shop at a local supermarket. During months 4-6, participants will be asked to continue following the DASH eating plan listed in the brochure but will no longer be provided the grocery gift card.

Primary outcome measure

  • Feasibility as assessed by the number of participants enrolled [ Time Frame: Baseline ]
  • Acceptability as assessed by the Acceptability of the Intervention Measure survey [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jessica Yeh, PhD

410-614-4316hyeh1@jhmi.edu

Letitia Thomas

410-281-1600

Locations

Johns Hopkins ProHealth Clinical Research Unit

Recruiting

Baltimore, Maryland, United States, 21207

Contacts

Letitia Thomas

410-281-1600lthomas7@jhmi.edu

Principal Investigator:

Jessica Yeh, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • hypertension
  • type 2 diabetes
  • diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.