Practice-based Trial of Blood Pressure Control in African Americans
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 10/31/2013 |
| Iliyowasilishwa Kwanza: | 02/15/2010 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 02/15/2010 |
| Iliyotumwa Kwanza: | 02/16/2010 |
| Sasisho la Mwisho Liliwasilishwa: | 11/11/2013 |
| Sasisho la Mwisho Lilichapishwa: | 11/12/2013 |
| Tarehe halisi ya kuanza kwa masomo: | 01/31/2010 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 06/30/2012 |
| Tarehe ya Kukamilisha Utafiti: | 06/30/2012 |
Hali au ugonjwa
Uingiliaji / matibabu
Behavioral: Therapeutic Lifestyle Changes (MINT-TLC)
Behavioral: Usual Care
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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. | Behavioral: 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. |
| 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. | 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. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months. [6 months]
Hatua za Matokeo ya Sekondari
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]
