Practice-based Trial of Blood Pressure Control in African Americans
TLC-Clinic
1 other identifier
interventional
194
1 country
4
Brief Summary
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) on blood pressure (BP) reduction, their effectiveness remains untested in primary care practices, especially among minority patients who share a greater burden of HTN-related outcomes including chronic kidney disease, stroke and heart failure. This randomized controlled trial offers a unique opportunity to address this gap in the literature. Among 200 hypertensive African-Americans who receive care in community- based primary care practices, we will test the effectiveness of a culturally-tailored comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) vs. Usual Care (UC). MINT-TLC is designed to help patients make appropriate TLC and develop skills to maintain these changes long-term. Patients in the MINT-TLC group will attend weekly group classes focused on TLC for 12 weeks (intensive phase); followed by individual motivational interviewing (MINT) sessions for 3 months (maintenance phase). Trained research personnel will deliver MINT-TLC with appropriate treatment fidelity procedures. Patients in the UC condition will receive a single individual counseling session on TLC and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic blood pressure from baseline to 6 months. Secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and proportion of patients with adequate blood pressure control at 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Feb 2010
Typical duration for phase_3 hypertension
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 13, 2013
November 1, 2013
2.4 years
February 16, 2010
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months.
6 months
Secondary Outcomes (1)
The secondary outcomes are the levels of physical activity, percent change in weight, dietary intake of fruits and vegetables, 24-hour urinary sodium excretion and BP control rates at 6 months.
6 months
Study Arms (2)
Usual Care
ACTIVE COMPARATORPatients randomized to the Usual Care (UC) condition will receive standard hypertension (HTN) treatment recommendations as determined by their physicians. In addition, they will receive a 30-minute individual counseling session on therapeutic lifestyle modification, similar to PREMIER. We feel obligated ethically to provide this minimal intervention to patients in the UC group given that counseling on TLC is a standard recommendation for treatment of hypertension. To match the MINT-TLC group for content of intervention material, those in the UC group will receive print versions of the intervention materials.
Therapeutic Lifestyle Changes (MINT-TLC)
EXPERIMENTALThis intervention is based on established clinical practice guidelines for prevention and treatment of hypertension (HTN), which recommends weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, reducing alcohol intake, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained research personnel. Patients will attend 10 classes over 12 weeks (intensive phase) followed by individual monthly MINT sessions for 3 months (maintenance phase). We chose the intervention schedules to pattern after the methodology of therapeutic lifestyle interventions with proven efficacy in hypertensive patients, specifically, Trial of Nonpharmacologic Approaches in Elderly Hypertensives (TONE) and PREMIER trials.
Interventions
This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension(HTN), which recommends weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, reducing alcohol intake, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained research personnel. Patients will attend 10 classes over 12 weeks (intensive phase) followed by individual monthly MINT sessions for 3 months (maintenance phase). We chose the intervention schedules to pattern after the methodology of therapeutic lifestyle interventions with proven efficacy in hypertensive patients, specifically, Trial of Nonpharmacologic Approaches in Elderly Hypertensives (TONE) and PREMIER trials.
Patients randomized to the Usual Care (UC) condition will receive standard hypertension (HTN) treatment recommendations as determined by their physicians. In addition, they will receive a 30-minute individual counseling session on therapeutic lifestyle modification, similar to PREMIER. We feel obligated ethically to provide this minimal intervention to patients in the UC group given that counseling on TLC is a standard recommendation for treatment of hypertension. To match the MINT-TLC group for content of intervention material, those in the UC group will receive print versions of the intervention materials.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Receiving care within the NYU Ambulatory Care Network for at least one year.
- Patient must have uncontrolled HTN defined as an average SBP≥140 mmHg or DBP≥90 mmHg (SBP≥130 mmHg or DBP≥80 mmHg for patients with diabetes or chronic kidney disease) on at least two previous visits in the past year
- English speaking
- Self-identify as Black, or African American;
- Permission by patient's physician to participate in the study.
- CARE-DIAG score \< 6 (participants age 60 and older only)
You may not qualify if:
- Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks including attend intervention classes if he/she were to be randomized to the intervention group).
- Participation in other clinical trials.
- Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record).
- Blood pressure reading ≥ 180/110 at initial screening/baseline visit
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Columbia Universitycollaborator
- Hebrew Home at Riverdalecollaborator
- New York City Health and Hospitals Corporationcollaborator
Study Sites (4)
Woodhull Medical & Mental Health Center
Brooklyn, New York, 11206, United States
Governeur Hospital
New York, New York, 10002, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Lincoln Hospital and Harlem Hospital
New York, New York, 10037, United States
Related Publications (3)
Ogunlade AO, Williams SK, Joseph J, Onakomaiya DO, Eimicke JP, Teresi JA, Williams O, Ogedegbe G, Spruill TM. Prevalence and correlates of depression among black and Latino stroke survivors with uncontrolled hypertension: a cross-sectional study. BMJ Open. 2020 Dec 8;10(12):e040461. doi: 10.1136/bmjopen-2020-040461.
PMID: 33293392DERIVEDSchoenthaler A, Luerassi L, Silver S, Odedosu T, Kong J, Ravenell J, Teresi JA, Ogedegbe G. Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks. Am J Hypertens. 2016 Feb;29(2):280-7. doi: 10.1093/ajh/hpv100. Epub 2015 Jul 1.
PMID: 26135553DERIVEDSchoenthaler A, Luerassi L, Teresi JA, Silver S, Kong J, Odedosu T, Trilling S, Errico A, Uvwo O, Sebek K, Adekoya A, Ogedegbe G. A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial. Trials. 2011 Dec 22;12:265. doi: 10.1186/1745-6215-12-265.
PMID: 22192273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gbenga G Ogedegbe, M.D.
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 13, 2013
Record last verified: 2013-11