Team Lifestyle Immersion Hypertension Control Project

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Meharry Medical College
Study ID
NCT07201948
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: — BEHAVIORAL
    1. : Two distinct groups will be enrolled: * Those diagnosed with hypertension: BP \>=140/90, within the last 2 years. * Those with BP \>=130/80. Not yet diagnosed with hypertension. 2. . Intervention: Comprehensive and integrated intervention components * Implemented by 3 certified experts (Dietician, Fitness Trainer, Cardiologist) * Modules: Education, Demonstration, Practical skill development sessions. 3. . Intervention is based on American Hearts Association Life's Simple 7. The nutrition aspect will follow the DASH Diet plan.

Study Details

This project is focuses on reducing the risk and progression of hypertension among a population that records high incidence of hypertension and other chronic ailments such as heart disease, diabetes, kidney failure, and obesity, with similar control measures. Several clinical trials over the last five decades have emphasized the importance of supportive lifestyle modification in the control of chronic disease that include a healthy diet, physical activity, quitting tobacco use, reducing alcohol use to the minimum, self-management of the disease, and adequate sleep. Study participants will receive motivation and skill development support in additional to specific nutrition, physical fitness, and self-management counselling from certified experts. This intervention incorporates elements of the American Heart Association prescription for health, Life's Simple 7 (LS7) lifestyle modification, the Dietary Approaches to preventing Hypertension (DASH) eating plan. After receiving these interventions, participants will be contacted at 3-months, 6-months, and 12-months for follow-up. They will complete similar surveys to be compared to determine impact on their hypertension. This intervention is complementary to usual pharmaceutical hypertension management.

Key Dates

Start date
Jun 1, 2025
Status verified
Mar 2025
Primary completion
Dec 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Team Group
    4-6 participants will be assigned to a Team. They will be instructed to work together and motivate each other to adhere to the intervention components, to attend intervention activities, and meet lifestyle modification goals. They will receive the intervention knowledge and skills training from: * Dietician * Physical Fitness Trainer * cardiologist They will also receive other support to enhance their lifestyle immersion from the research team.
  • Active Comparator: Individual Group
    Individual participants will be instructed to self-motivate to adhere to the intervention components, to attend intervention activities, and meet lifestyle modification goals. They will receive the intervention knowledge and skills training from: * Dietician * Physical Fitness Trainer * cardiologist They will also receive other support to enhance their lifestyle immersion from the research team.

Primary Outcome Measure

Systolic and Diastolic Blood Pressure Change [ Time Frame: 6 months & 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Meharry Medical CollegeNashvilleTennessee37208-3501
Flora Ukoli, MD, MPH
[email protected]
16153275653
Adrian Samuels, Ph.D.
[email protected]
Chike Nzerue, MD (SUB_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Meharry Medical College· Nashville, TN

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