Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
DASH-Life
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started May 2025
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 24, 2026
March 1, 2026
1.9 years
March 31, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility as assessed by the number of participants enrolled
The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived.
Baseline
Acceptability as assessed by the Acceptability of the Intervention Measure survey
Acceptability of the intervention will be quantitatively measured by the Acceptability of Intervention Measure (AIM) survey. The survey consists of 4 items, each measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The score is calculated as the mean of the responses to the 4 items. A higher score is better.
3 months
Study Arms (2)
Self-Shopping DASH diet advice group (S-DASH)
ACTIVE COMPARATORCoach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins ProHealth Clinical Research Unit
Baltimore, Maryland, 21207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Yeh, PhD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 10, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 24, 2026
Record last verified: 2026-03