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Behavioural Intervention

Food Delivery and Cooking PLUS Aerobic Training (FoRKS+) 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

MAT Trial 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.Check my eligibility
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.See study design
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.

MAT Trial 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.

MAT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

MAT 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.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,722 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,634 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,757 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors able to participate in this clinical examination?

"This medical trial stipulates that potential participants must be between 35 and 75 years old. Conversely, there are 79 clinical trials available for minors below 18 and 1227 research opportunities designed for seniors above 65."

Answered by AI

What objectives has this trial been designed to accomplish?

"This medical trial will assess its primary outcome, the cognitive function composite score based on psychomotor speed, complex sequencing, semantic fluency and more at Week 52 post intervention start date. Secondary outcomes being monitored include participant adherence to treatment and assessments as well as any adverse events by study arm."

Answered by AI

Is this research effort still accepting new participants?

"Affirmative. Clinicaltrials.gov confirms that this medical trial, first posted on November 28th 2023, is actively recruiting patients. Specifically, 128 participants are sought from one location for the study's duration."

Answered by AI

Is there an opportunity to be included in this clinical experiment?

"Eligibility for this trial necessitates that potential participants regularly engage in aerobic activity and are between 35 and 75 years old. Presently, the team is looking to recruit 128 individuals."

Answered by AI

How many volunteers are involved in this healthcare research endeavor?

"Affirmative. According to the information posted on clinicaltrials.gov, this research study is actively recruiting patients; its initial posting was on November 28th 2023 and it has since been updated most recently on December 7th 2023. The trial aims to recruit 128 participants from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MIND Foods and Aerobic Training in Black Adults With HTN
Daniel Clark 2023. "MIND Foods and Aerobic Training in Black Adults With HTN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152614.
All > High Blood Pressure > Indianapolis
~85 spots leftby May 2027
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