Stress and Blood Pressure Management for Caregivers

(Stress/HTN Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kathy Wright, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Must be taking: Antihypertensives

Disqualifiers: Resistant hypertension, Active mindfulness/yoga

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Behavioural Intervention)
• MIM-DASH (Behavioural Intervention)
• MIM Only (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio State University Columbus, OH

Who Is Running the Clinical Trial?

Ohio State University Lead Sponsor

Robert Wood Johnson Foundation Collaborator

References

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

Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH) in Hypertensive African Americans. [2022] Hypertension increases the risk of developing Alzheimer's disease or related dementias. This pilot study's purpose was to examine the feasibility and acceptability of a novel intervention, Mindfulness in Motion (MIM) and Dietary Approaches to Stop Hypertension DASH (MIM DASH), to improve diet, mindfulness, stress, and systolic blood pressure (BP) in older African Americans with mild cognitive impairment (MCI) and hypertension.

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] Although the Dietary Approaches to Stop Hypertension (DASH) diet is an accepted nonpharmacologic treatment for hypertension, little is known about what patient characteristics affect dietary adherence and what level of adherence is needed to reduce blood pressure (BP).

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] The DASH (Dietary Approaches to Stop Hypertension) diet is a carbohydrate-rich, reduced-fat diet that lowers blood pressure (BP) and LDL-cholesterol. Whether partial replacement of some carbohydrate (C) with either protein (P) or unsaturated fat (U) can further improve these and other cardiovascular (CVD) risk factors is unknown.

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

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. [2023] The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is recommended for cardiovascular disease risk reduction. Assessment of dietary intake has been limited to subjective measures and a few biomarkers from 24-h urine collections.

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

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023] The Dietary Approaches to Stop Hypertension (DASH) diet has been recognized as effective to lower blood pressure in feeding trials, but compliance with the diet must be persistent to maximize health benefits in clinical practice. This paper reports a systematic review of the latest evidence on the method to assess DASH compliance and the corresponding patients' compliance in interventional settings.

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

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021] The Dietary Approaches to Stop Hypertension (DASH) trial showed that a diet rich in fruits, vegetables, low-fat dairy products with reduced total and saturated fat, cholesterol, and sugar-sweetened products effectively lowers blood pressure in individuals with prehypertension and stage I hypertension. Limited evidence is available on the safety and efficacy of the DASH eating pattern in special patient populations that were excluded from the trial. Caution should be exercised before initiating the DASH diet in patients with chronic kidney disease, chronic liver disease, and those who are prescribed renin-angiotensin-aldosterone system antagonist, but these conditions are not strict contraindications to DASH. Modifications to the DASH diet may be necessary to facilitate its use in patients with chronic heart failure, uncontrolled diabetes mellitus type II, lactose intolerance, and celiac disease. In general, the DASH diet can be adopted by most patient populations and initiated simultaneously with medication therapy and other lifestyle interventions.

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

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. [2020] The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure placed increased emphasis on lifestyle modification for the prevention and management of hypertension. The Dietary Approaches to Stop Hypertension (DASH) diet, rich in fruits, vegetables, nuts, and low-fat dairy foods, with reduced saturated and total fats, was found in clinical trials to lower blood pressure substantially and significantly. The DASH diet appears appropriate for use in the primary care setting, although it is unknown whether results will mirror those found in clinical trial.

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] Hypertension is a major cause of cardiovascular disease, and although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP), adherence is typically low. Mindfulness training adapted to improving health behaviors that lower BP could improve DASH adherence, in part through improved interoceptive awareness relevant to dietary consumption.

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

Nonpharmacologic management of hypertension in the elderly. [2013] Nonpharmacologic management of hypertension is all too often overlooked in the elderly. The Dietary Approaches to Stop Hypertension (DASH) diet, weight loss, physical activity, moderation of alcohol, and salt restriction, particularly when used in combination, are effective strategies to help control hypertension and reduce overall cardiovascular risk. Behavioral modification should form the cornerstone of hypertension treatment in the elderly.