Lifestyle Intervention for High Blood Pressure and Type 2 Diabetes

(DASH-Life Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: GLP-1, GIP, Insulin

Disqualifiers: Hypoglycemia, Cardiovascular event, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dietary changes and weight management can lower blood pressure and blood sugar in people with high blood pressure and type 2 diabetes. It compares two groups: one receives diet advice to shop for themselves (Self-Shopping DASH diet advice), and the other receives personalized coaching and groceries (Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention). The study aims to determine if these approaches improve health for residents in Baltimore areas with limited access to healthy foods. Individuals with both high blood pressure and type 2 diabetes living in these areas may find this trial beneficial.

As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle interventions that could significantly improve health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on certain diabetes or weight loss medications like insulin or GLP-1. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the DASH diet, which stands for Dietary Approaches to Stop Hypertension, is generally safe and easy to follow. It emphasizes eating foods like fruits and vegetables that help lower blood pressure and improve heart health. Research indicates that people on the DASH diet often experience lower blood pressure and better overall health.

In the Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention, previous studies have shown that combining DASH-style groceries with guidance from a dietitian can lower blood pressure and bad cholesterol. Participants usually manage the program well without major issues.

For the Self-Shopping DASH diet advice, studies highlight that this approach effectively supports heart health and reduces the risk of high blood pressure and related diseases. The DASH diet is known for its heart-healthy benefits and is widely recommended by health professionals.

Overall, previous research has shown both approaches in this trial to be safe. They focus on promoting healthy eating habits, which are generally good for managing blood pressure and diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH) and the Self-Shopping DASH diet advice (S-DASH) because they offer innovative lifestyle-based approaches to managing high blood pressure and Type 2 diabetes. Unlike standard medications like ACE inhibitors, diuretics, or metformin, these interventions focus on personalized dietary changes and lifestyle coaching. C-DASH is particularly promising because it pairs participants with a coach who provides tailored grocery and lifestyle guidance, potentially leading to more sustainable health improvements. S-DASH empowers individuals with structured dietary advice, allowing them to independently shop and make health-conscious food choices. This trial could reveal how personalized and self-guided dietary strategies might enhance current treatment options.

What evidence suggests that this trial's treatments could be effective for high blood pressure and type 2 diabetes?

Research shows that the DASH diet can help lower blood pressure and blood sugar. In this trial, participants will join one of two groups. The Coach-Directed DASH group, where participants receive home-delivered groceries and advice from a dietitian, has significantly reduced blood pressure and bad cholesterol in studies. Meanwhile, the Self-Shopping DASH group, where participants buy their own groceries, has also led to meaningful drops in blood pressure. One study found that people on the DASH diet experienced greater reductions in systolic blood pressure (the top number in a blood pressure reading) compared to those who shopped for groceries themselves. Both methods show promise in managing high blood pressure and diabetes through dietary changes. ^{1 2 3 6 7}

Who Is on the Research Team?

Jessica Yeh, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults over 18 with type 2 diabetes and high blood pressure living in certain low-income Baltimore areas can join. They must have an HbA1c level of at least 6.5%, a systolic BP between 120-159 mmHg, normal potassium levels, and adequate kidney function.

Inclusion Criteria

* Baseline systolic BP 120-159 mmHg (with or without medications.)

* Serum potassium level \>3.0 and \<5 mmol/L

* 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.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Self-Shopping DASH (S-DASH) diet advice or Coaching DASH (C-DASH) diet advice for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention
• Self-Shopping DASH diet advice

Trial Overview The study tests if tailored grocery shopping advice plus lifestyle coaching (C-DASH) or just self-shopping advice for the DASH diet (S-DASH) helps lower blood sugar and blood pressure in adults with hypertension and diabetes over six months.

How Is the Trial Designed?

Group I: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH) Experimental Treatment 1 Intervention

Group II: Self-Shopping DASH diet advice group (S-DASH) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A 2-month intervention led by a nurse practitioner for 45 overweight and obese hypertensive patients resulted in significant improvements in diet and lifestyle, as measured by standardized questionnaires.

Participants experienced an average weight loss of 3.6 pounds, indicating that the DASH diet and lifestyle changes were effective in promoting better health outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. Jarl, J., Tolentino, JC., James, K., et al.[2021]

The DASH diet, which focuses on fruits, vegetables, low-fat dairy, whole grains, nuts, fish, and poultry while reducing fats and sugars, has been shown to effectively lower blood pressure, as demonstrated in the DASH clinical trial.

Healthcare practitioners, including dietitians, play a crucial role in helping individuals adopt the DASH diet by addressing ambivalence, enhancing motivation, and providing tailored dietary advice to fit personal lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. Windhauser, MM., Ernst, DB., Karanja, NM., et al.[2019]

The Nourish trial will involve 300 adults with hypertension over 12 months, testing a smartphone app designed to improve adherence to the DASH eating pattern, which is a proven method for managing high blood pressure.

The primary goal is to see if this digital health intervention can significantly enhance adherence to the DASH diet and lead to reductions in blood pressure, using evidence-based behavior change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension. Miller, HN., Berger, MB., Askew, S., et al.[2022]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06921356

Groceries Plus Multi-Component Lifestyle Intervention for ... 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.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/604215

Groceries Plus Multi-Component Lifestyle Intervention for ... Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41206973/

DASH-Patterned Groceries and Effects on Blood Pressure Conclusions and relevance: In this study, a program of home-delivered, DASH-style groceries plus dietitian counseling decreased BP and LDL ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12413951/

Digital-Based Nutrition Interventions Employing the Dietary ... Conclusion: Technology-based DASH diet interventions yielded favorable health outcomes, particularly in reducing BP and dietary salt intake, as well as improved ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/ijhy/6175223

Digital‐Based Nutrition Interventions Employing the Dietary ... Conclusion: Technology-based DASH diet interventions yielded favorable health outcomes, particularly in reducing BP and dietary salt intake, as ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/32/NCT05393232/Prot_000.pdf

Effects of DASH Groceries on Blood Pressure in Black Residents ... Adherence to the DASH Diet in African American and White Adults with High Blood. Pressure: Results from the ENCORE Trial. J Acad Nutr Diet. 2012;112(11):1763 ...