300 Participants Needed

DASH Diet for High Blood Pressure

(DISH Trial)

CM
Overseen ByCarissa M Baker-Smith, MD MPH MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Nemours Children's Clinic

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the DASH-FV treatment for high blood pressure?

Research shows that the DASH diet, which is part of the DASH-FV treatment, is effective in lowering blood pressure in people with hypertension (high blood pressure). Studies indicate that following the DASH diet can lead to significant reductions in blood pressure, especially when combined with other lifestyle changes.12345

Is the DASH diet safe for people with high blood pressure?

The DASH diet is generally safe for most people and can be used alongside medications and other lifestyle changes. However, people with chronic kidney or liver disease, or those on certain medications, should be cautious and may need to adjust the diet. It is also important to consider modifications for those with specific conditions like heart failure, diabetes, lactose intolerance, or celiac disease.678910

How is the DASH-FV treatment different from other treatments for high blood pressure?

The DASH-FV treatment is unique because it focuses on a diet rich in fruits, vegetables, and low-fat dairy products, which helps lower blood pressure and cholesterol levels without medication. This approach is different from standard drug treatments as it emphasizes dietary changes rather than pharmaceuticals.69111213

What is the purpose of this trial?

Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.

Eligibility Criteria

This trial is for adolescents with high blood pressure, who may also be experiencing food insecurity. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and not have conditions that could interfere with the study.

Inclusion Criteria

I have high blood pressure.
I am between 12 and 17 years old.

Exclusion Criteria

I cannot eat by mouth.
I have high blood pressure caused by another condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DASH diet intervention or standard nutrition counseling

12 weeks

Follow-up

Participants are monitored for changes in blood pressure and dietary intake

6 months

Treatment Details

Interventions

  • DASH-FV
Trial Overview The trial is testing a DASH diet intervention involving home delivery of produce compared to standard care. It's set up so one group gets the special diet and another just gets advice on nutrition without additional support.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: DASH diet toolkit armActive Control1 Intervention
A group of participants receiving DASH diet intervention
Group II: STANDARDPlacebo Group1 Intervention
Nutrition counseling only as part of standard of care

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials
128
Recruited
18,000+

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.
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 is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.
There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.
Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review.Kwan, MW., Wong, MC., Wang, HH., et al.[2023]
The Satter House Trial of Reduced Sodium Meals (SOTRUE) showed that a low sodium meal plan for 14 days in older adults led to a reduction in seated systolic blood pressure (SBP) from 123 to 112 mmHg, indicating potential benefits for blood pressure management.
While the low sodium diet did lower SBP by 4.8 mmHg compared to a typical sodium diet, the results were not statistically significant, suggesting that further research with a larger sample size and longer duration is necessary to confirm the efficacy and safety of low sodium meals in older adults.
The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial.Juraschek, SP., Millar, CL., Foley, A., et al.[2021]

References

Baseline diet modifies the effects of dietary change. [2021]
Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. [2021]
The impact of individualised nutritional therapy according to DASH diet on blood pressure, body mass, and selected biochemical parameters in overweight/obese patients with primary arterial hypertension: a prospective randomised study. [2020]
Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]
Influence of dietary modifications on the blood pressure response to antihypertensive medication. [2011]
Associations Between Dietary Patterns and Subclinical Cardiac Injury: An Observational Analysis From the DASH Trial. [2021]
The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. [2021]
The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]
Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]
Effects of the Modified DASH Diet on Adults With Elevated Blood Pressure or Hypertension: A Systematic Review and Meta-Analysis. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Effects of the DASH diet alone and in combination with exercise and weight loss on blood pressure and cardiovascular biomarkers in men and women with high blood pressure: the ENCORE study. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. [2023]
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