HypertensionTLIPNCT07201948
Team Lifestyle Immersion Hypertension Control Project
A study testing Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: in people with Hypertension, run by Meharry Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Meharry Medical College
Nashville, Tennessee, 37208-3501
Flora Ukoli, MD, MPH, 16153275653, fukoli@mmc.edu
Adrian Samuels, Ph.D., asamuels@mmc.edu
About this study
Official title: Community Team Lifestyle Immersion Program for Chronic Disease Prevention and Control
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.
Read the 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
- Being tested
- Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:Behavioural
Also called Life's Simple 7, DASH Diet
- : 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.
- . Intervention: Comprehensive and integrated intervention components
- Implemented by 3 certified experts (Dietician, Fitness Trainer, Cardiologist)
- Modules: Education, Demonstration, Practical skill development sessions.
- . Intervention is based on American Hearts Association Life's Simple 7. The nutrition aspect will follow the DASH Diet plan.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months & 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Flora Ukoli, MD, MPH, Study director, Meharry Medical CollegeStephena Miller-Hughes, Ph.D., Study director, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201948
- Sponsor's protocol ID
- 25-02-1555
- Other IDs
- 5P50MD017347-04
- Acronym
- TLIP
- Status last verified
- Mar 2025
- First submitted
- 7 May 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Team Lifestyle Immersion Program for Chronic Disease Prevention and Control
- ClinicalTrials.gov ID
- NCT07201948
- Acronym / sponsor ID
- TLIP / 25-02-1555
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Team Group | Active comparator | Behavioral: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: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. |
| Individual Group | Active comparator | Behavioral: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:Also: Life's Simple 7, DASH Diet1. : 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. | Behavioural | Individual Group, Team Group |
Primary outcome
Systolic and Diastolic Blood Pressure Change
Time frame: 6 months & 12 months.
Systolic and Diastolic blood pressure change will be computed as: SBP (enrollment) - SBP (Follow-up) DBP (enrollment) - DBP (Follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flora Ukoli, MD, MPH study director
Meharry Medical College
Stephena Miller-Hughes, Ph.D. study director
Meharry Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: in people with Hypertension, run by Meharry Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flora Ukoli, MD, MPH (16153275653, fukoli@mmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood Pressure Change (time frame: 6 months & 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.