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A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized
Antoinette Schoenthaler1, Leanne Luerassi, Jeanne A Teresi
1Center for Healthful Behavior Change, New York University School of Medicine, Department of Medicine, Division of General Internal Medicine, New York, NY, USA. Antoinette.Schoenthaler@nyumc.org
Insights
This study tested a lifestyle intervention for uncontrolled hypertension in African Americans. The MINT-TLC program improved blood pressure control and lifestyle behaviors in participants.
Area of Science:
- Public Health
- Cardiovascular Medicine
- Behavioral Science
Background:
- Hypertension (HTN) is a major public health issue in the US, with significant morbidity, mortality, and economic costs.
- African Americans experience a disproportionately higher burden of HTN-related outcomes.
- Therapeutic lifestyle changes (TLC) are proven to reduce blood pressure (BP), but their effectiveness in primary care, particularly for African Americans, is understudied.
Purpose of the Study:
- To test the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention (MINT-TLC) versus Usual Care (UC) for uncontrolled hypertension in low-income African Americans.
- To assess the impact of MINT-TLC on blood pressure reduction and key lifestyle behaviors.
- To inform the refinement and integration of MINT-TLC into standard treatment protocols for hypertensive African Americans.
Main Methods:
- A randomized controlled trial involving 200 low-income African Americans with uncontrolled hypertension.
- The MINT-TLC group received 10 weekly group classes and 3 monthly individual motivational interviewing sessions.
- The Usual Care group received a single counseling session and print materials.
- Primary outcome: change in systolic and diastolic BP from baseline to 6 months.
- Secondary outcomes: changes in physical activity, weight, fruit/vegetable intake, and sodium excretion.
Main Results:
- The study is designed to provide data on the effectiveness of the MINT-TLC intervention.
- Expected results will include changes in blood pressure and lifestyle behaviors at 6 months.
- Analysis will focus on within-patient changes from baseline.
Conclusions:
- This trial will yield crucial data for refining the MINT-TLC intervention.
- Findings will guide the integration of MINT-TLC into standard care for hypertensive African Americans.
- The study aims to maximize the translation of MINT-TLC into effective clinical practice.
Background:
Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.
Methods/Design:
This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.
Discussion:
This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.
Trial Registration:
Clinicaltrials.gov NCT01070056.
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