Team Lifestyle Immersion Hypertension Control Project

NCT07201948 | Recruiting

• 2 other identifiers: 25-02-15555P50MD017347-04
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Systolic and Diastolic Blood Pressure Change

  Systolic and Diastolic blood pressure change will be computed as: SBP (enrollment) - SBP (Follow-up) DBP (enrollment) - DBP (Follow-up)

  6 months & 12 months.

Study Arms (2)

Team Group

ACTIVE COMPARATOR

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.

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

Individual Group

ACTIVE COMPARATOR

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.

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

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.

Also known as: Life's Simple 7, DASH Diet

Individual Group; Team Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meharry Medical College: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208-3501, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Physical Fitness; Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Flora Ukoli, MD, MPH

  Meharry Medical College

  STUDY DIRECTOR

• Stephena Miller-Hughes, Ph.D.

  Meharry Medical College

  STUDY DIRECTOR

Central Study Contacts

Flora Ukoli, MD, MPH

CONTACT

16153275653; fukoli@mmc.edu

Adrian Samuels, Ph.D.

CONTACT

1615-207-8382; asamuels@mmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two Study Arms: 1. . Team Group 2. . Individual Group All participants will receive the same intervention, but will be randomized into two study arms. Team Group: 4-6 participants will be assigned to work on their lifestyle as a team, motivating each other to adhere to the study intervention elements. Individual Group: Each participant will work on their own to adhere to the study intervention elements.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: October 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-03

Locations

US (1)