HypertensionPhase 3TLC-ClinicNCT01070056
Practice-based Trial of Blood Pressure Control in African Americans
A Phase 3 study testing Therapeutic Lifestyle Changes (MINT-TLC) in people with Hypertension and Physical Activity, run by NYU Langone Health at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Physical Activity, Diet
- What is being tested?
- Therapeutic Lifestyle Changes (MINT-TLC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Woodhull Medical & Mental Health Center
Brooklyn, New York, 11206
Governeur Hospital
New York, New York, 10002
Bellevue Hospital Center
New York, New York, 10016
Lincoln Hospital and Harlem Hospital
New York, New York, 10037
About this study
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
Read the 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.
- Conditions
- Hypertension, Physical Activity, Diet, Medication Adherence
- Being tested
- Therapeutic Lifestyle Changes (MINT-TLC), Usual Care
- Keywords
- Blood Pressure, Lifestyle Changes, African American
- Medical subject headings
- Hypertension, Motor Activity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Lifestyle Changes (MINT-TLC)Behavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
| Therapeutic Lifestyle Changes (MINT-TLC) | Experimental | 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. Receives: Behavioral: Therapeutic Lifestyle Changes (MINT-TLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Hebrew Home at Riverdale, New York City Health and Hospitals Corporation
- Responsible party
- Sponsor
- Investigators
- Gbenga G Ogedegbe, M.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070056
- Sponsor's protocol ID
- R01HL087301-01
- Acronym
- TLC-Clinic
- Status last verified
- Nov 2013
- First submitted
- 16 Feb 2010
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33293392Schoenthaler 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.
PubMed 26135553Schoenthaler 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.
PubMed 22192273
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice-based Trial of Blood Pressure Control in African Americans
- ClinicalTrials.gov ID
- NCT01070056
- Acronym / sponsor ID
- TLC-Clinic / R01HL087301-01
- Conditions
- Hypertension, Physical Activity, Diet, Medication Adherence
- Keywords
- Blood Pressure, Lifestyle Changes, African American
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Columbia University, Hebrew Home at Riverdale, New York City Health and Hospitals Corporation
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CarePatients 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) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Therapeutic Lifestyle Changes (MINT-TLC) |
| Usual CarePatients 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. | Behavioural | Usual Care |
Primary outcome
The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 33293392Ogunlade 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.
- Derived from this study: PubMed 26135553Schoenthaler 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.
- Derived from this study: PubMed 22192273Schoenthaler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gbenga G Ogedegbe, M.D. principal investigator
NYU Langone Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic Lifestyle Changes (MINT-TLC) in people with Hypertension and Physical Activity, run by NYU Langone Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070056, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.