Stress and Blood Pressure Management for Caregivers

(Stress/HTN Trial)

Overseen By Sandra Solove, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Antihypertensives

Disqualifiers: Resistant hypertension, Active mindfulness/yoga

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist African American women who care for family members with dementia while managing high blood pressure (hypertension). It tests two approaches: Mindfulness in Motion (MIM), which includes meditation and breathing exercises, and the DASH diet (Dietary Approaches to Stop Hypertension), which promotes healthy eating and exercise. Participants will join one of three groups: MIM and DASH combined, MIM only, or DASH only. Ideal participants are African American women who are unpaid caregivers for someone with dementia and also take medication for high blood pressure. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing hypertension and caregiving stress.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it requires participants to have hypertension treated with medication, it seems likely that you can continue your current treatment.

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

Research shows that both the Mindfulness in Motion (MIM) program and the Dietary Approaches to Stop Hypertension (DASH) diet are easy to follow. Studies have found that combining MIM and DASH is effective and suitable for African Americans with high blood pressure, indicating it is generally safe and comfortable for participants.

Mindfulness in Motion alone has helped manage stress and lower blood pressure in caregivers without causing serious side effects, suggesting it is safe for most individuals.

The DASH diet, known for lowering blood pressure, has been tested in many studies and typically does not cause harmful side effects. It involves healthy eating, such as adding more fruits and vegetables, which is safe for most people.

Overall, previous studies have shown these treatments to be safe, meaning they are unlikely to cause harm. However, like any new activity or diet change, discussing participation with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for managing stress and blood pressure in caregivers because they offer a novel approach by combining dietary and mindfulness strategies. Unlike traditional treatments that may focus solely on medication or counseling, the MIM-DASH approach uniquely blends the Dietary Approaches to Stop Hypertension (DASH) diet with mindfulness-based stress reduction, delivered through accessible telehealth sessions. This method not only aims to improve diet and reduce stress but also fosters peer support and interaction, which can be crucial for caregivers. By integrating these elements, researchers hope to provide more holistic and flexible options that cater specifically to the unique challenges faced by caregivers.

What evidence suggests that this trial's treatments could be effective for managing stress and blood pressure in African American women caregivers?

This trial will compare three interventions for managing stress and blood pressure in caregivers. Research has shown that combining Mindfulness in Motion (MIM) with the DASH diet, as participants in the MIM-DASH arm will receive, can effectively lower blood pressure. Specifically, one study found that this combination reduced the systolic blood pressure by 7.2 mmHg. Participants in the MIM Only arm will receive mindfulness programs alone, which have been linked to lower blood pressure and improved mental health. Meanwhile, the DASH Only arm will focus on the DASH diet by itself, which has also been proven to lower blood pressure and enhance heart health by reducing salt intake and promoting healthy eating. These methods have strong evidence supporting their effectiveness in managing high blood pressure and reducing stress, especially in diverse populations. ^{1 2 6 7 8}

Who Is on the Research Team?

Kathy Wright, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for African American women over 40 who care unpaid for someone with dementia at least 10 hours a week, have high blood pressure treated with medication, and can use the internet or phone. They must speak English and rate the person they're caring for as needing significant help. Those already doing mindfulness or yoga, or with resistant high blood pressure aren't eligible.

Inclusion Criteria

Caregiver rating of the PLWD of 2 or greater on the Alzheimer's Dementia-8 scale

I have high blood pressure and am taking medication for it.

I am 40 years old or older.

Exclusion Criteria

My high blood pressure does not improve despite taking three different medications.

I am actively participating in a mindfulness or yoga program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MIM-DASH, MIM only, or DASH only interventions in eight weekly 1-hour group sessions via telehealth

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for stress, self-care, and blood pressure outcomes

6 months

3 visits (virtual) at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• DASH Only
• MIM-DASH
• MIM Only

Trial Overview

The study tests two interventions: Mindfulness in Motion (MIM) which includes seated movement and meditation exercises; and DASH diet tailored to Black Americans focusing on healthy eating and physical activity. The goal is to see if these reduce caregiver stress and improve blood pressure control.

How Is the Trial Designed?

Group I: MIM-DASH Experimental Treatment 1 Intervention

A trained MIM provider (layperson) and a registered dietitian will deliver the MIM DASH group intervention in eight 1-hour (30 minutes MIM and 30 minutes DASH) sessions via telehealth (video and telephone access).

Group II: MIM Only Experimental Treatment 1 Intervention

The MIM-only intervention group will receive the MIM education only in eight weekly sessions of 30 minutes each. To maintain equipoise among the intervention groups, this group will also have 30 minutes of "social time" to interact with the trainer and peers.

Group III: DASH Only Experimental Treatment 1 Intervention

The DASH-only group will receive the DASH education only in eight weekly sessions of 30 minutes each. This group will also have 30 minutes of "social time" to interact with the trainer and peers, will receive their education from a different interventionist (also a registered dietician) and receive two coaching calls per month for 3 months, in this case focused on healthy eating DASH principles.

DASH Only is already approved in United States, Canada, European Union for the following indications:

Approved in United States as DASH for:

• Hypertension management
• Cardiovascular health improvement

Approved in Canada as DASH for:

• Hypertension management
• Cardiovascular health improvement

Approved in European Union as DASH for:

• Hypertension management
• Cardiovascular health improvement

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

Published Research Related to This Trial

The Mindfulness-Based Blood Pressure Reduction (MB-BP) program significantly improved interoceptive awareness, as measured by the MAIA questionnaire, with an increase of 0.54 points compared to the control group after 6 months.

Participants with poor initial adherence to the DASH diet showed a notable improvement in their DASH adherence scores, increasing by 0.62 points due to the MB-BP program, indicating that mindfulness training can enhance dietary compliance in individuals with elevated blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. Loucks, EB., Kronish, IM., Saadeh, FB., et al.[2023]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

A study involving 329 participants showed that following the DASH diet for 8 weeks resulted in significant changes in serum concentrations of 44 metabolites compared to a control diet and a fruit and vegetables diet, indicating the diet's impact on metabolic health.

The research identified a specific panel of 10 metabolites that can effectively distinguish adherence to the DASH diet, suggesting potential for these metabolites to be used as biomarkers for dietary assessment in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. Rebholz, CM., Lichtenstein, AH., Zheng, Z., et al.[2023]

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 Mindfulness in Motion and Dietary Approaches to Stop Hypertension (MIM DASH) intervention was found to be feasible and culturally acceptable for older African Americans with mild cognitive impairment and hypertension, with good attendance in group sessions.

Participants in the MIM DASH group experienced a clinically significant reduction in systolic blood pressure by 7.2 mmHg, compared to only a 0.7 mmHg reduction in the attention-only group, highlighting the intervention's potential effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH) in Hypertensive African Americans. Wright, KD., Klatt, MD., Adams, IR., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

The DASH diet, along with weight loss, physical activity, alcohol moderation, and salt restriction, are effective non-drug strategies for managing hypertension in elderly individuals.

Combining these lifestyle changes is particularly beneficial for controlling blood pressure and reducing cardiovascular risk, highlighting the importance of behavioral modification as a key component of hypertension treatment in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management of hypertension in the elderly. Padiyar, A.[2013]

The OmniHeart study is a randomized crossover trial involving 160 adults with prehypertension or Stage 1 hypertension, designed to compare the effects of a carbohydrate-rich diet with diets high in protein or unsaturated fat on blood pressure and cholesterol levels.

The study aims to provide insights into how different macronutrient compositions can influence cardiovascular risk factors, potentially guiding dietary recommendations for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Carey, VJ., Bishop, L., Charleston, J., et al.[2017]

Citations

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ncbi.nlm.nih.gov

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DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf

The diet has been tested in several clinical trials and has been shown to lower cholesterol, saturated fats, and blood pressure.

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ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16156

Dietary Approaches to Stop Hypertension ...

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The DASH diet compared with a control diet reduced SBP levels to a higher extent in trials with sodium intake >2400 mg/d than in trials with ...

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sciencedirect.com

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Dietary Approaches to Stop Hypertension diet retains ...

Consumption of these DASH-style diets for 6 wk reduced all measures of BP (P < 0.05) with no differences in responses between the DASH-CF and DASH-P. Conclusion ...

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Adherence to dietary approaches to stop hypertension (DASH) diet as a protective factor for ischemic stroke and its influence on disability level.

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Stress and Hypertension in Dementia Caregivers NCT ...

Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are effective in managing hypertension.

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What Is the DASH Diet for Hypertension?

The DASH diet encourages people to choose whole grains and lean proteins as a big portion of their meals. Whole grains like whole wheat, oats, and brown rice ...