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

Trial Summary

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.

What data supports the effectiveness of the treatment DASH Only, Dietary Approaches to Stop Hypertension, MIM-DASH, Mindfulness in Motion-Dietary Approaches to Stop Hypertension, MIM-DASH, MIM Only, Mindfulness in Motion for caregivers?

Research shows that the DASH diet can effectively lower blood pressure and reduce cardiovascular disease risk. Additionally, combining the DASH diet with Mindfulness in Motion (MIM) may improve diet, mindfulness, stress, and blood pressure in individuals with mild cognitive impairment and hypertension. ^{1 2 3 4 5}

Is the DASH diet and Mindfulness in Motion safe for humans?

The DASH diet is generally safe for most people and can be used alongside medications and other lifestyle changes. However, people with certain conditions like chronic kidney or liver disease should be cautious and may need to adjust the diet. Mindfulness in Motion has been studied for its feasibility and acceptability, but specific safety data is not detailed in the available research. ^{1 2 3 6 7}

How is the Stress and Blood Pressure Management for Caregivers treatment different from other treatments for high blood pressure?

This treatment is unique because it combines the DASH diet, which is known to lower blood pressure through healthy eating, with Mindfulness in Motion (MIM), a mindfulness practice that can improve stress management and adherence to the diet. This combination aims to enhance both dietary habits and stress reduction, which are important for managing blood pressure. ^{1 2 7 8 9}

What is the purpose of this trial?

Due to health and wealth disparities, no demographic group is more at risk than African American women for the double jeopardy of stress from caregiving for persons living with dementia (PLWD) and stress associated with hypertension (HTN). This double jeopardy puts those they care for in jeopardy as well: Reduced quality of life and longevity, disability, cognitive decline, and stroke associated with HTN1 impede caregiving activities and resultant health and well-being for persons living with Alzheimer's disease and related dementias (ADRD). Although successful multi-component interventions have addressed ADRD caregiver stress (REACH II) and the Savvy Caregiver program, to our knowledge there are no interventions that target the complexity of chronic caregiving stress and HTN self-care for African American women caregivers of persons living with ADRD. This project will test two interventions for their effectiveness in improving outcomes for the target group: Mindfulness in Motion (MIM) and the Dietary Approaches to Stop Hypertension (DASH). MIM includes mindful awareness and movement from a seated position, breathing exercises, healthy sleep, and guided mindfulness meditation. The DASH component will be tailored for Black Americans. It uses a critical thinking approach that involves problem solving, participant-centered goal setting, health coaching, reflection, and development of self-efficacy (confidence) to promote physical activity and healthy eating. Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples.

Research Team

Kathy Wright, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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, 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 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]

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, 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]

References

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

Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH) in Hypertensive African Americans. [2022]

2. United States 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. [2022]

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

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]

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

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. [2023]

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

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]

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

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

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

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

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

Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. [2023]

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

Nonpharmacologic management of hypertension in the elderly. [2013]