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Stress and Blood Pressure Management for Caregivers (Stress/HTN Trial)
N/A
Recruiting
Led By Kathy Wright, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to reduce stress & hypertension for African-American women caregivers of dementia patients, using mindfulness & DASH tailored for Black Americans.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
There are generally no severe side effects expected from MIM or DASH diet interventions. Participants might experience mild discomfort when starting new exercise routines or changing dietary habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Pressure
Secondary study objectives
Acceptability Scale
Block food frequency questionnaire
Credibility Scale
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: MIM-DASHExperimental Treatment1 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 OnlyExperimental Treatment1 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 OnlyExperimental Treatment1 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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,034 Total Patients Enrolled
Robert Wood Johnson FoundationOTHER
159 Previous Clinical Trials
695,835 Total Patients Enrolled
Kathy Wright, PhDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
28 Total Patients Enrolled
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