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Team Lifestyle Immersion Hypertension Control Project
NCT07201948 · Meharry Medical College
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Community Team Lifestyle Immersion Program for Chronic Disease Prevention and Control
About this study
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.
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.
Study design
Enrollment target: 220 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-06-01
Estimated completion: 2028-04-30
Last updated: 2025-10-01
Interventions
Behavioral: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:
Primary outcomes
- • Systolic and Diastolic Blood Pressure Change (6 months & 12 months.)
Sponsor
Meharry Medical College · other
With: National Institute on Minority Health and Health Disparities (NIMHD)
Contacts & investigators
ContactFlora Ukoli, MD, MPH · contact · fukoli@mmc.edu · 16153275653
ContactAdrian Samuels, Ph.D. · contact · asamuels@mmc.edu · 1615-207-8382
InvestigatorFlora Ukoli, MD, MPH · study_director, Meharry Medical College
InvestigatorStephena Miller-Hughes, Ph.D. · study_director, Meharry Medical College
All locations (1)
Meharry Medical CollegeRecruiting
Nashville, Tennessee, United States