- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070056
Practice-based Trial of Blood Pressure Control in African Americans (TLC-Clinic)
November 12, 2013 updated by: NYU Langone Health
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We will test the effectiveness of a primary care practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) in a two-arm, randomized controlled trial (RCT) in 200 low-income, poorly controlled hypertensive African-American patients.
MINT is a directive, participant-centered, counseling approach for initiating and maintaining behavior change that has proven effective in improving adherence to various health behaviors.
We hypothesize that among African Americans with poorly controlled hypertension (HTN), those randomized to TLC group, compared to those randomized to UC, will exhibit a greater reduction in systolic and diastolic blood pressure (BP); greater levels of physical activity; percent change in weight; increased intake of fruits and vegetables; and reduced 24-hour urinary sodium excretion at 6 months.The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months.
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.
Blood pressure will be assessed with a well-validated automated digital BP monitor (BPTru), following American Heart Association guidelines.
Therapeutic lifestyle behaviors will be assessed with validated self-report measures: Dietary intake will be assessed with the NCI's fruit/vegetable and fat brief dietary assessment questionnaires; and physical activity will be assessed with the Nurses Health Study and Health Professionals Study's physical activity questionnaire.
Percent weight loss will be estimated from the difference in weight between baseline and 6 months, while 24-hour urinary sodium excretion will be used to estimate dietary sodium intake.
Patients are categorized as having controlled BP if their average BP that fulfills the Seventh Joint National Committee on Detection, Evaluation and Treatment of Hypertension (JNC-7) criteria of SBP < 130 and DBP < 80 mmHg (patients with diabetes or chronic kidney disease); or SBP < 140 and DBP < 90 mmHg (for all other patients).
Regardless of group assignments, all outcomes data will be assessed at baseline, 3 months, and 6 months.
Study Type
Interventional
Enrollment (Actual)
194
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Brooklyn, New York, United States, 11206
- Woodhull Medical & Mental Health Center
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New York, New York, United States, 10016
- Bellevue Hospital Center
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New York, New York, United States, 10002
- Governeur Hospital
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New York, New York, United States, 10037
- Lincoln Hospital and Harlem Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Usual Care
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.
|
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.
|
EXPERIMENTAL: Therapeutic Lifestyle Changes (MINT-TLC)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gbenga G Ogedegbe, M.D., NYU Langone Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Schoenthaler 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.
- Schoenthaler 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (ESTIMATE)
February 17, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 13, 2013
Last Update Submitted That Met QC Criteria
November 12, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HL087301-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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