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Behavioural Intervention

Diet and Exercise for High Blood Pressure (MAT Trial)

N/A
Recruiting
Led By Daniel O Clark, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Activity independence per functional activities questionnaire (FAQ; <3 responses of "Require Assistance" and 0 responses of "Dependent")
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of follow-up at 52-weeks.
Awards & highlights

Summary

This trial tests whether diet and exercise can help improve cognition in Black adults with high blood pressure. Participants will receive assessments and optional blood draw.

Who is the study for?
This trial is for Black adults aged 35-75 living in Marion County with high blood pressure, who are physically inactive, have stable housing with a kitchen, and can see/read street signs. They must be fluent in English and independent in daily activities. Those with normal cognition scores are eligible.
What is being tested?
The study tests the MIND diet combined with aerobic exercise (FoRKS+) against Enhanced Usual Care (EUC) to see which is better at improving brain function in participants. It includes cognitive assessments, blood pressure monitoring, weight checks, diabetes screening via fingerstick test, and optional DNA testing.
What are the potential side effects?
Potential side effects from the interventions may include muscle soreness or fatigue due to increased physical activity from aerobic training. Dietary changes could cause digestive adjustments but typically do not pose severe risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can do most daily activities by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of follow-up at 52-weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of follow-up at 52-weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, semantic fluency, interference and list learning and delayed recall at Week 28.
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, semantic fluency, interference and list learning and delayed recall at Week 52.
Secondary study objectives
Average participant self-ratings of intervention acceptability.
Number of participants with study-related adverse events (AE) by treatment arm.
Participant adherence to outcome assessments.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Food Delivery and Cooking PLUS Aerobic Training (FoRKS+)Experimental Treatment1 Intervention
Participants randomized to FoRKS+ will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS+ intervention. Following HTN SMES completion, FoRKS+ continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16. Intervention continues with aerobic exercise led by health coaches via Webex. Classes start in Week 13 with one session per week, increasing to two sessions per week in Weeks 17-28.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.

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Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,383 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,087 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,875 Total Patients Enrolled
~85 spots leftby May 2027
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