Team Lifestyle Immersion Hypertension Control Project
ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorMeharry Medical College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements:
Behavioral1. : 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Team GroupActive comparator 1 intervention
Group B: Individual GroupActive comparator 1 intervention
Trial outcomes
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)
Time frame
6 months & 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Meharry Medical College
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov