Recruiting

Lifestyle Modification

Sponsor:

Meharry Medical College

Code:

NCT07201948

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT07201948

Start date

Jun 1, 2025

Status verified date

Mar, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Reside in Davidson and surrounding counties of Tennessee.
  • At least 30 years old.
  • At increased risk for developing hypertension (already diagnosed or a strong family history).
  • Be able to consent.
  • Not planning to move from this study area in 12 months after enrollment.

Exclusion Criteria:

  • Does not reside in Davidson and surrounding counties.
  • Less than 30 years old, or older than 80 years.
  • Not at assessed increased risk for hypertension.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Flora Ukoli, MD, MPH

16153275653fukoli@mmc.edu

Adrian Samuels, Ph.D.

1615-207-8382asamuels@mmc.edu

Locations

Meharry Medical College

Recruiting

Nashville, Tennessee, United States, 37208-3501

Contacts

Flora Ukoli, MD, MPH

16153275653fukoli@mmc.edu

Adrian Samuels, Ph.D.

asamuels@mmc.edu

More Information

Sponsor

Meharry Medical College

Last update posted

Oct 1, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Meharry Medical College on 2025-10-01.