90 Participants Needed

Stress and Blood Pressure Management for Caregivers

(Stress/HTN Trial)

KW
SS
Overseen BySandra Solove, MA
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

Who Is on the Research Team?

KW

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.
See 4 more

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?
3Treatment groups
Experimental Treatment
Group I: MIM-DASHExperimental Treatment1 Intervention
Group II: MIM OnlyExperimental Treatment1 Intervention
Group III: DASH OnlyExperimental Treatment1 Intervention

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

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Approved in United States as DASH for:
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Approved in Canada as DASH for:
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Approved in European Union as DASH for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

DASH Diet To Stop Hypertension - StatPearls - NCBI BookshelfThe diet has been tested in several clinical trials and has been shown to lower cholesterol, saturated fats, and blood pressure.
Dietary Approaches to Stop Hypertension ...The DASH intervention proved more effective than routine care in initial systolic BP improvement and longer term improvement in endothelial function and diet ...
Dietary Approaches to Stop Hypertension (DASH) Diet and ...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 sodium intake ≤2400 ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32330233/
Dietary Approaches to Stop Hypertension (DASH) Diet and ...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 ...
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 ...
Adherence to Dietary Approaches to Stop Hypertension ...Adherence to dietary approaches to stop hypertension (DASH) diet as a protective factor for ischemic stroke and its influence on disability level.
Stress and Hypertension in Dementia Caregivers NCT ...Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are effective in managing hypertension.
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 ...
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