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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention, Self-Shopping DASH diet advice for high blood pressure and type 2 diabetes?

Research shows that the DASH diet can help reduce cardiovascular risks in people with type 2 diabetes and improve dietary habits in those with high blood pressure. Tailored interventions, like the one in the study, have been effective in helping people stick to the DASH diet, which is known to lower blood pressure and improve heart health. ^{1 2 3 4 5}

Is the DASH diet safe for people with high blood pressure and type 2 diabetes?

The DASH diet is generally safe for most people, but those with chronic kidney or liver disease, or on certain medications, should be cautious. It may need adjustments for people with uncontrolled diabetes, heart failure, lactose intolerance, or celiac disease. ^{1 2 6 7 8}

How is the Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention treatment different from other treatments for high blood pressure and type 2 diabetes?

This treatment is unique because it combines personalized grocery shopping guidance with the DASH diet, which is known for lowering blood pressure through a diet rich in fruits, vegetables, and low-fat dairy. Unlike standard treatments that may focus solely on medication, this approach emphasizes lifestyle changes and personalized support to improve diet adherence. ^{4 6 8 9 10}

Research Team

Jessica Yeh, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I am 18 years old or older.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of a Dietary Approaches to Stop Hypertension eating plan on features of the metabolic syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of the Dietary Approaches to Stop Hypertension (DASH) eating plan on cardiovascular risks among type 2 diabetic patients: a randomized crossover clinical trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A Tailored Behavioral Intervention to Promote Adherence to the DASH Diet. [2020]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The PREMIER intervention helps participants follow the Dietary Approaches to Stop Hypertension dietary pattern and the current Dietary Reference Intakes recommendations. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Association between adherence to the Dietary Approaches to Stop Hypertension diet with food security and weight status in adult women. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension. [2022]

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Effect of a Digital Behavioral Weight Loss Intervention on Adherence to the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern in Medically Vulnerable Primary Care Patients: Results from a Randomized Controlled Trial. [2020]