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A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial

Ravenell, Joseph; Thompson, Hayley; Cole, Helen; Plumhoff, Jordan; Cobb, Gia; Afolabi, Lola; Boutin-Foster, Carla; Wells, Martin; Scott, Marian; Ogedegbe, Gbenga
BACKGROUND: Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men. METHODS/DESIGN: MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged >/=50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months. DISCUSSION: This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01092078.
PMCID:3844539
PMID: 24011142
ISSN: 1745-6215
CID: 641502

Role of Bariatric Surgery as Treatment for Type 2 Diabetes in Patients Who Do Not Meet Current NIH Criteria: A Systematic Review and Meta-Analysis

Parikh, Manish; Issa, Reda; Vieira, Dorice; McMacken, Michelle; Saunders, John K; Ude-Welcome, Aku; Schubart, Ulrich; Ogedegbe, Gbenga; Pachter, H Leon
PMID: 23890843
ISSN: 1072-7515
CID: 512922

Global Health Selective: a novel interdisciplinary clerkship on clinical knowledge and skills for global health at New York University School of Medicine [Meeting Abstract]

Bertelsen, N.; DallaPiazza, M.; Ogedegbe, O.; Hopkins, M. A.
ISI:000324029000233
ISSN: 1360-2276
CID: 557502

European society of hypertension position paper on ambulatory blood pressure monitoring

O'Brien, Eoin; Parati, Gianfranco; Stergiou, George; Asmar, Roland; Beilin, Laurie; Bilo, Grzegorz; Clement, Denis; de la Sierra, Alejandro; de Leeuw, Peter; Dolan, Eamon; Fagard, Robert; Graves, John; Head, Geoffrey A; Imai, Yutaka; Kario, Kazuomi; Lurbe, Empar; Mallion, Jean-Michel; Mancia, Giuseppe; Mengden, Thomas; Myers, Martin; Ogedegbe, Gbenga; Ohkubo, Takayoshi; Omboni, Stefano; Palatini, Paolo; Redon, Josep; Ruilope, Luis M; Shennan, Andrew; Staessen, Jan A; vanMontfrans, Gert; Verdecchia, Paolo; Waeber, Bernard; Wang, Jiguang; Zanchetti, Alberto; Zhang, Yuqing
Ambulatory blood pressure monitoring (ABPM) is being used increasingly in both clinical practice and hypertension research. Although there are many guidelines that emphasize the indications for ABPM, there is no comprehensive guideline dealing with all aspects of the technique. It was agreed at a consensus meeting on ABPM in Milan in 2011 that the 34 attendees should prepare a comprehensive position paper on the scientific evidence for ABPM.This position paper considers the historical background, the advantages and limitations of ABPM, the threshold levels for practice, and the cost-effectiveness of the technique. It examines the need for selecting an appropriate device, the accuracy of devices, the additional information and indices that ABPM devices may provide, and the software requirements.At a practical level, the paper details the requirements for using ABPM in clinical practice, editing considerations, the number of measurements required, and the circumstances, such as obesity and arrhythmias, when particular care needs to be taken when using ABPM.The clinical indications for ABPM, among which white-coat phenomena, masked hypertension, and nocturnal hypertension appear to be prominent, are outlined in detail along with special considerations that apply in certain clinical circumstances, such as childhood, the elderly and pregnancy, and in cardiovascular illness, examples being stroke and chronic renal disease, and the place of home measurement of blood pressure in relation to ABPM is appraised.The role of ABPM in research circumstances, such as pharmacological trials and in the prediction of outcome in epidemiological studies is examined and finally the implementation of ABPM in practice is considered in relation to the issue of reimbursement in different countries, the provision of the technique by primary care practices, hospital clinics and pharmacies, and the growing role of registries of ABPM in many countries.
PMID: 24029863
ISSN: 0263-6352
CID: 666692

Correlates of isolated nocturnal hypertension and target organ damage in a population-based cohort of african americans: the jackson heart study

Ogedegbe, Gbenga; Spruill, Tanya M; Sarpong, Daniel F; Agyemang, Charles; Chaplin, William; Pastva, Amy; Martins, David; Ravenell, Joseph; Pickering, Thomas G
BACKGROUND: African Americans have higher rates of nocturnal hypertension and less nocturnal blood pressure (BP) dipping compared with whites. Although nocturnal hypertension is associated with increased cardiovascular morbidity and mortality, its clinical significance among those with normal daytime BP is unclear. This paper reports the prevalence and correlates of isolated nocturnal hypertension (INH) in a population-based cohort of African Americans enrolled in the Jackson Heart Study (JHS). METHODS: The study sample included 425 untreated, normotensive and hypertensive JHS participants who underwent 24-hour ambulatory BP monitoring (ABPM), echocardiography, and 24-hour urine collection. Multiple logistic regression and 1-way analysis of variance models were used to test the hypothesis that those with INH have worse target organ damage reflected by greater left ventricular (LV) mass and proteinuria compared with normotensive participants. RESULTS: Based on 24-hour ABP profiles, 19.1% of participants had INH. In age and sex-adjusted models, participants with INH had greater LV mass compared with those who were normotensive (P = 0.02), as well as about 3 times the odds of LV hypertrophy and proteinuria (Ps < 0.10). However, multivariable adjustment reduced the magnitude and statistical significance of each of these differences. CONCLUSIONS: INH was associated with increased LV mass compared with normo tension in a population-based cohort of African Americans enrolled in the JHS. There were trends toward a greater likelihood of LV hyper trophy and proteinuria among participants with INH vs. those who were normotensive. The clinical significance of the noted target organ damage should be explored in this population.
PMCID:3879438
PMID: 23676475
ISSN: 0895-7061
CID: 425312

Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial

Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Obaro, Stephen K; Ezeanolue, Chinenye O; Ogedegbe, Gbenga G
BACKGROUND:A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. METHODS:This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized 'baby shower.' The baby shower includes refreshments, gifts exchange, and an educational game show testing participants' knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the effect of HBI on the rate of HIV testing among male partners of pregnant women and the rate of PMTCT completion among HIV-infected pregnant women. DISCUSSION/CONCLUSIONS:Results of this study will provide further understanding of the most effective strategies for increasing HIV testing among pregnant women in hard-to-reach communities. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov, NCT01795261.
PMCID:3700826
PMID: 23758933
ISSN: 1748-5908
CID: 3035432

Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association

Brook, Robert D; Appel, Lawrence J; Rubenfire, Melvyn; Ogedegbe, Gbenga; Bisognano, John D; Elliott, William J; Fuchs, Flavio D; Hughes, Joel W; Lackland, Daniel T; Staffileno, Beth A; Townsend, Raymond R; Rajagopalan, Sanjay
Many antihypertensive medications and lifestyle changes are proven to reduce blood pressure. Over the past few decades, numerous additional modalities have been evaluated in regard to their potential blood pressure-lowering abilities. However, these nondietary, nondrug treatments, collectively called alternative approaches, have generally undergone fewer and less rigorous trials. This American Heart Association scientific statement aims to summarize the blood pressure-lowering efficacy of several alternative approaches and to provide a class of recommendation for their implementation in clinical practice based on the available level of evidence from the published literature. Among behavioral therapies, Transcendental Meditation (Class IIB, Level of Evidence B), other meditation techniques (Class III, Level of Evidence C), yoga (Class III, Level of Evidence C), other relaxation therapies (Class III, Level of Evidence B), and biofeedback approaches (Class IIB, Level of Evidence B) generally had modest, mixed, or no consistent evidence demonstrating their efficacy. Between the noninvasive procedures and devices evaluated, device-guided breathing (Class IIA, Level of Evidence B) had greater support than acupuncture (Class III, Level of Evidence B). Exercise-based regimens, including aerobic (Class I, Level of Evidence A), dynamic resistance (Class IIA, Level of Evidence B), and isometric handgrip (Class IIB, Level of Evidence C) modalities, had relatively stronger supporting evidence. It is the consensus of the writing group that it is reasonable for all individuals with blood pressure levels >120/80 mm Hg to consider trials of alternative approaches as adjuvant methods to help lower blood pressure when clinically appropriate. A suggested management algorithm is provided, along with recommendations for prioritizing the use of the individual approaches in clinical practice based on their level of evidence for blood pressure lowering, risk-to-benefit ratio, potential ancillary health benefits, and practicality in a real-world setting. Finally, recommendations for future research priorities are outlined.
PMID: 23608661
ISSN: 0194-911x
CID: 667462

The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH): From theory to clinical trial implementation

Boutin-Foster, Carla; Scott, Ebony; Rodriguez, Anna; Ramos, Rosio; Kanna, Balavenkatesh; Michelen, Walid; Charlson, Mary; Ogedegbe, Gbenga
This paper describes the application of a translational research model in developing The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH), a theoretically-based, randomized controlled trial. TRIUMPH targets blood pressure control among African-Americans with hypertension in a community health center and public hospital setting. TRIUMPH applies positive affect, self-affirmation, and motivational interviewing as strategies to increase medication adherence and blood pressure control. A total of 220 participants were recruited in TRIUMPH and are currently being followed. This paper provides a detailed description of the theoretical framework and study design of TRIUMPH and concludes with a critical reflection of the lessons learned in the process of implementing a health behavior intervention in a community-based setting. TRIUMPH provides a model for incorporating the translational science research paradigm to conducting pragmatic behavioral trials in a real-world setting in a vulnerable population. Lessons learned through interactions with our community partners reinforce the value of community engagement in research.
PMCID:4128940
PMID: 23403073
ISSN: 1551-7144
CID: 288092

Are there consequences of labeling patients with prehypertension? An experimental study of effects on blood pressure and quality of life

Spruill, Tanya M; Feltheimer, Seth D; Harlapur, Manjunath; Schwartz, Joseph E; Ogedegbe, Gbenga; Park, Youngjun; Gerin, William
OBJECTIVE: The prehypertension classification was introduced to facilitate prevention efforts among patients at increased risk for hypertension. Although patients who have been told that they have hypertension report worse outcomes than unaware hypertensives, little is known about whether or not prehypertension labeling has negative effects. We evaluated the effects of labeling individuals with prehypertension on blood pressure and health-related quality of life three months later. METHODS: One hundred adults (aged 19 to 82 [mean=40.0] years; 54% women; 64% racial/ethnic minorities) with screening blood pressure in the prehypertensive range (120-139/80-89mmHg) and no history of diagnosis or treatment of elevated blood pressure were randomly assigned to either a "Labeled" group in which they were informed of their prehypertension, or an "Unlabeled" group in which they were not informed. Subjects underwent office blood pressure measurement, 24-hour ambulatory blood pressure monitoring and completed self-report questionnaires at baseline and at three months. RESULTS: Multilevel mixed effects regression analyses indicated that changes in the white coat effect, office blood pressure, mean daytime ambulatory blood pressure, and physical and mental health did not differ significantly between the two groups. Adjusting for age, sex, race/ethnicity and body mass index did not affect the results. CONCLUSION: These findings suggest that labeling patients with prehypertension does not have negative effects on blood pressure or quality of life. Additional research is needed to develop approaches to communicating with patients about their blood pressure that will maximize the clinical and public health impact of the prehypertension classification.
PMCID:3631319
PMID: 23597332
ISSN: 0022-3999
CID: 304942

The Counseling Older Adults to Control Hypertension (COACH) trial: Design and methodology of a group-based lifestyle intervention for hypertensive minority older adults

Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A
The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12months. The secondary outcomes are blood pressure control at 12months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.
PMCID:3805359
PMID: 23462343
ISSN: 1551-7144
CID: 315932