Team Lifestyle Immersion Hypertension Control Project

NCT ID: NCT07201948

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-04-30

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.

Detailed Description

African Americans continue to bear disproportionate chronic disease morbidity and mortality, and tend to report lower benefits from clinical trials that include lifestyle modifications in addition to pharmaceutical management. This project uses hypertension as an index case for other chronic ailments such as heart disease, diabetes, kidney failure, and obesity, especially as their control measures are similar. 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. Although socioeconomic factors can impact disease management outcomes, African Americans may require additional motivational support to first accept the notion of change of lifestyle and to adhere to the changes that may be a major shift in their eating and exercise habits. The need to positively impact chronic disease, particularly hypertension, morbidity and morbidity in the African American population deserves both pharmaceutical and non-pharmaceutical approaches. This intervention incorporates elements of the American Heart Association prescription for health, Life's Simple 7 (LS7) lifestyle modification, the Dietary Approaches to Stop Hypertension (DASH) eating plan, provides the knowledge and skills necessary for success, and introduces the motivation boost of participating in teams of 4-6 participants. The primary intervention outcome is adherence to the seven elements of LS7, measured by LS7 Scores at enrollment, and at 6- and 12-months follow-up. Secondary outcomes will include changes in SBP/DBP, BMI, Waist girth, and A1C. The study shall compare Team versus Individual study arms for participants recruited and managed in the health center and the home settings separately and combined. Intermediate outcomes will include, and not limited to biomarkers such as urine sodium, serum Plasminogen activator inhibitor-1 (PAI-1) for hypertension, Interleukin 6 (IL6), and C-reactive protein (CRP) for obesity.

The goal is to enroll 220 participants, half from health institutions (Nashville General Hospital & Mathew Walker Comprehensive Health Center) and the other half from the community (MDHA residence, Health Fairs, Churches etc.). Half of the participants will be people already diagnosed with hypertension (BP 140/90 or higher, or on hypertension medication) and half will be those at increased risk of developing hypertension with BP measurement 130/80 and above.

The study will be implemented in three phases:

Phase 1: Health Behavior Assessment. Phase 2: Intervention Development. Phase 3: Intervention Effectiveness Evaluation.

Intervention:

Participants will complete the study survey and a food frequency questionnaire and enrollment. they will also provide 5ml venous blood sample for biomarker assay. They will complete the same surveys at follow-up at 6- and 12-months to provide data for evaluation effectiveness.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Life's Simple 7; DASH Diet

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Meharry Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flora Ukoli, MD, MPH

Role: STUDY_DIRECTOR

Meharry Medical College

Stephena Miller-Hughes, Ph.D.

Role: STUDY_DIRECTOR

Meharry Medical College

Locations

Meharry Medical College

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Flora Ukoli, MD, MPH

Role: CONTACT

fukoli@mmc.edu

16153275653

Adrian Samuels, Ph.D.

Role: CONTACT

asamuels@mmc.edu

1615-207-8382

Facility Contacts

Flora Ukoli, MD, MPH

Role: primary

fukoli@mmc.edu

16153275653

Adrian Samuels, Ph.D.

Role: backup

asamuels@mmc.edu

Other Identifiers

5P50MD017347-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-02-1555

Identifier Type: -

Identifier Source: org_study_id