Lifestyle Changes for High Blood Pressure

(TLIP Trial)

Overseen By Adrian Samuels, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Meharry Medical College

Disqualifiers: Outside age range, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if lifestyle changes can help manage high blood pressure (hypertension) and reduce the risk of related diseases like heart issues and diabetes. Participants will receive support in areas such as diet, exercise, and self-care from experts, including dieticians and fitness trainers. They will either join a team that motivates each other or work individually to achieve lifestyle goals through the Lifestyle Immersion Intervention. This trial is suitable for residents of Davidson County, Tennessee, who are at risk for hypertension or have a family history of it and can commit to staying in the area for a year. As an unphased trial, this study offers a unique opportunity to contribute to valuable research on lifestyle interventions for hypertension.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that the lifestyle changes are complementary to usual pharmaceutical management, so you may be able to continue your current medications.

What prior data suggests that this lifestyle intervention is safe for managing high blood pressure?

Research has shown that lifestyle changes can safely and effectively help manage high blood pressure. Studies have found that a healthy diet and regular exercise can lower blood pressure in individuals whose condition does not respond well to treatment. Specifically, one study revealed that patients who followed a structured diet and exercise program experienced significant improvements in their blood pressure over four months.

Moreover, maintaining a healthy lifestyle while taking prescribed blood pressure medication can reduce the risk of death from any cause, including heart disease and cancer. Another study involving over a million people from 80 countries demonstrated that lifestyle changes can effectively help manage blood pressure.

These findings suggest that lifestyle changes are generally well-tolerated and associated with positive health outcomes. This approach is considered a safe addition to standard treatments for high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Immersion Intervention for high blood pressure because it emphasizes a team-based approach to lifestyle changes, which can enhance motivation and adherence. Unlike standard treatments like medication or solo lifestyle modifications, this approach involves participants working together with support from a dietician, physical fitness trainer, and cardiologist. This collective effort could lead to more sustainable lifestyle changes and potentially greater improvements in blood pressure control. Additionally, the intervention provides personalized support and skills training, which is not typically part of standard care. By fostering community and individualized guidance, this method holds promise for more effective long-term management of high blood pressure.

What evidence suggests that this trial's lifestyle interventions could be effective for high blood pressure?

Research has shown that lifestyle changes can help lower high blood pressure. In this trial, participants will join different groups to test the effectiveness of these changes. One study found that a team approach improved blood pressure control from 51.0% to 67.4%. In this trial, the Team Group will collaborate to motivate each other and adhere to lifestyle modifications. Another study showed that most people experienced lower blood pressure after six months of lifestyle changes. The Individual Group in this trial will self-motivate to achieve similar lifestyle goals. These changes typically include eating a healthy diet, exercising regularly, and getting support from health experts. Such lifestyle changes are known to help manage high blood pressure and improve overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

Flora Ukoli, MD, MPH

Principal Investigator

Meharry Medical College

Stephena Miller-Hughes, Ph.D.

Principal Investigator

Meharry Medical College

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure, particularly those at risk of chronic diseases like heart disease and diabetes. Participants should be motivated to adopt a healthier lifestyle through diet, exercise, and self-management. It's not specified who can't join the trial.

Inclusion Criteria

Reside in Davidson and surrounding counties of Tennessee

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

I am under 30 or over 80 years old.

I am not at high risk for high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Health Behavior Assessment

Participants complete a health behavior assessment, including surveys and a food frequency questionnaire, and provide a blood sample for biomarker assay

4 weeks

Intervention Development

Participants receive knowledge and skills training from dieticians, physical fitness trainers, and cardiologists, and are supported in lifestyle modification

6 months

Monthly visits (in-person or virtual)

Intervention Effectiveness Evaluation

Participants are evaluated for intervention effectiveness through follow-up surveys and biomarker assessments

6 months

Follow-up at 6 and 12 months

Follow-up

Participants are monitored for changes in blood pressure, BMI, waist girth, and A1C, and adherence to lifestyle modifications

12 months

3 visits (in-person or virtual) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Immersion Intervention

Trial Overview The study tests a Lifestyle Immersion Intervention focusing on nutrition, physical fitness, and blood pressure self-monitoring. It includes motivation support and counseling based on American Heart Association guidelines and DASH eating plans.

How Is the Trial Designed?

Group I: Team Group Active Control 1 Intervention

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 II: Individual Group Active Control 1 Intervention

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 Is Running the Clinical Trial?

Meharry Medical College

Lead Sponsor

Trials

19

Recruited

6,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07201948

Team Lifestyle Immersion Hypertension Control Project This project is focuses on reducing the risk and progression of hypertension among a population that records high incidence of hypertension ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12032512/

Impact of Lifestyle Medicine Interventions on the ... Fifty-one (51) participants (51/57, 89%) completed the program. All interventions reduced blood pressure indices between T0 and T6, except the combined ...

3. journals.lww.com journals.lww.com/jpbs/fulltext/2025/06002/effectiveness_of_a_comprehensive_nursing_care.43.aspx

Effectiveness of a Comprehensive Nursing Care Package ... The study discovered that implementing a comprehensive nursing care package successfully decreased hypertension, improved lifestyle practices, and improved ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S193317111500741X

Effectiveness of a multidisciplinary intervention to improve ... Overall, BP control rates increased from 51.0% to 67.4% (adjusted odds ratio, 1.58; 95% confidence interval, 1.44–1.74) by the end of the intervention phase and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06348225

Post-exercise Hot Water Immersion to Improve Overnight ... The goal of this clinical trial is to test whether putting a participant's legs in a hot bath after exercise improves blood pressure in people with higher blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9867179/

Compliance to Multidisciplinary Lifestyle Intervention ... Data in patients with full compliance (n = 30) indicate that lifestyle modifications in resistant hypertension significantly reduced 24 h both ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.055329

Effects of Lifestyle Modification on Patients With Resistant ... Diet and exercise can lower BP in patients with resistant hypertension. A 4-month structured program of diet and exercise as adjunctive therapy ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788558

Lifestyle, Antihypertensive Medication, and Mortality ... Adherence to healthy lifestyle and antihypertensive medication treatment was associated with lower risk of all-cause, cardiovascular, and cancer mortality.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10246465/

Comprehensive effects of lifestyle reform, adherence, and ... The program examined nearly 1.2 million people in 80 countries who had not had their blood pressure monitored in the previous year and discovered that 34.9% of ...