Training at the Welch Center

Study To Understand Fall Reduction and Vitamin D in You (STURDY) 

Welch Center Investigators: Appel L, Miller ER, Michos E, Coresh J, Mitchell C, Charleston J 

Description: STURDY is a completed, Bayesian response-adaptive, randomized dose-finding trial designed to select the best dose of vitamin D supplementation and to potentially confirm the efficacy of that dose for fall prevention and other related outcomes. Vitamin D doses are 200, 1,000, 2,000, and 4,000 IU/day. Participants (n=688) are community-dwelling adults, aged 70+ (~20% black, ~45% women), with a baseline serum 25(OH)D level of 10 to < 30 ng/ml, who are at high risk for falling. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health  
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Chronic Renal Insufficiency Cohort Study (CRIC) 

Welch Center Investigators: Appel L, Miller ER, Ishigami J, Rebholz C, Charleston J 

Description: CRIC is an ongoing, NIDDK-sponsored, longitudinal, observational study with a racially and ethnically diverse cohort of over 5,000 participants with chronic kidney disease (CKD), ~ 50% with diabetes. With over 10 years of follow-up, CRIC has the following major goals: (a) identification of novel predictors of CKD progression, and (b) identification of CVD risk factors, among individuals with CKD.  

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Disparities and Social Determinants of Health, Kidney Disease, Metabolomics and Genetics 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

African American Study of Kidney Disease and Hypertension (AASK) 

Welch Center Investigators: Appel L, Miller ER, , Rebholz C, Ishigami J 

Description: AASK is a completed NIDDK-sponsored study with 2 phases: (a) a 2x3 factorial randomized trial that assessed the effect of strict versus usual BP control and 3 anti-hypertensive agents on the progression of CKD and (b) a cohort study with extended follow-up. Trial participants were 1,097 African Americans with chronic kidney disease attributed to hypertension. Several trainees have conducted secondary analyses of this landmark study that has > 10 years of follow-up. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Disparities and Social Determinants of Health, Kidney Disease, Metabolomics and Genetics 
• Study Design: Clinical Trials, Observational Studies 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Practice-based Opportunities for Weight Reduction (POWER) 

Welch Center Investigators: Appel L, Clark J, Yeh J, Wang NY, Coughlin J, Daumit G, Bennett W, Gudzune K, Charleston J  

Description: POWER is a completed, NHLBI-sponsored randomized trial that tested 2 behavioral weight loss interventions in > 400 obese patients with cardiovascular risk factors. The trial documented that a remotely delivered, multi-component intervention sustained weight loss over 2 years. Given the simplicity of the design and the high quality and completeness of data collection, several trainees have conducted secondary analyses. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Weight Loss Maintenance Trial (WLM) 

Welch Center Investigators: Appel L, Coughlin J, Charleston J 

Description: WLM is a completed, NHLBI-supported, randomized, controlled trial that tested the effects of 2 lifestyle interventions to sustain weight loss. One intervention involved personal contact and the other used a web-based intervention. With 5 years of follow-up, this trial is one of the longest trials of weight loss interventions. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Disparities and Social Determinants of Health 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Dietary Approaches to Stop Hypertension (DASH) 

Welch Center Investigators: Appel L, Miller E, Rebholz C, Charleston J 

Description: DASH was a randomized, controlled feeding study that tested the effects of 3 dietary patterns on blood pressure and other outcomes. Trials results have been extremely influential. Given the simplicity of the design (3 arms) and the high quality and completeness of data collection, numerous trainees have conducted secondary analyses. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Dietary Approaches to Stop Hypertension- Sodium Trial (DASH-Na) 

Welch Center Investigators: Appel L, Miller E, Rebholz C, Charleston J 

Description: DASH-Sodium was a randomized, controlled feeding study that tested the effects of 3 levels of sodium intake in 2 dietary patterns on blood pressure and other outcomes. Trials results have been extremely influential. Several trainees have conducted secondary analyses of this trial. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Optimal Macronutrient Intake for Carbohydrate Trial (OmniCarb) 

Welch Center Investigators: Appel L, Miller E, Charleston J 

Description: OmniCarb was a recently completed randomized, controlled feeding study that tested the effects of amount (high vs low %kcal carb) and type (high vs low glycemic index) on blood pressure, lipids, and insulin sensitivity. Trials results have been extremely influential. Trainees have started to conduct secondary analyses of this trial. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Optimal Macronutrient Intake Trial to Prevent Heart Disease (OmniHeart) 

Welch Center Investigators: Miller E, Charleston J, Mueller N 

Description: OmniHeart was a randomized, controlled feeding study that tested the effects of 3 diets, each with reduced saturated fat, on blood pressure and other outcomes. Trials results have been extremely influential. Several trainees have conducted secondary analyses of this trial. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

PREMIER  

Welch Center Investigators: Appel L, Rebholz C, Charleston J 

Description: PREMIER was a randomized, controlled behavioral intervention trial that tested the effects of 2 multi-component lifestyle interventions (weight loss, physical activity, sodium reduction, DASH diet) on blood pressure and other outcomes. Given the simplicity of the design (3 arms) and the high quality and completeness of data collection, several trainees have conducted secondary analyses. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Trials of Hypertension Prevention (TOHP)  

Welch Center Investigators: Appel L 

Description: In Phase 1 of Trials of Hypertension Prevention (TOHP), individuals aged 30-54 years with high normal BP to lifestyle approaches that might prevent hypertension, including weight loss, sodium reduction, stress reduction, and pill supplements (potassium, calcium, magnesium, fish oil) for up to 18 months. In Phase 2 of TOHP, individuals were randomized to weight loss, sodium reduction, both, or neither for 3 to 4 years. Clinical outcomes over extended follow-up period, up to 23 years, were also collected. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Resolve  

Welch Center Investigators: Appel L, Matsushita K, Miller ER, Brady T, Neupane D, Henry M, Ishigami J, Charleston, J  

Description: Resolve is a global health initiative funded by the Bloomberg Philanthropies. The CEO of the overall project is Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention and former commissioner of the New York City (NYC) Health Department. The initiative aims to save more than 100 million lives by preventing heart attacks and strokes and will help countries close life-threatening gaps in epidemic preparedness and response. JHSPH will support two core programs: hypertension control and sodium reduction.  We provides expert technical support in operational research, expertise in program evaluation and research methodology, supports peer-reviewed publications, including original research and systematic reviews, provides training for professional staff in the target LMICs and builds implementation research capacity in the target countries.  Our group is a diverse, inter-disciplinary team of investigators from across Johns Hopkins, including faculty from the Welch Center, the Department of International Health, the Department of Epidemiology, and the Division of General Internal Medicine, as well as a faculty from other academic centers.    

• Study Design: Multiple types of studies, including observational studies, clinical trials, qualitative research 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: Yes 

DASH for Diabetes Diet Intervention Trial (DASH4D)  

Welch Center Investigators: Appel LJ, Yeh J, Pilla S, Wang NY, Miller ER, Charleston J 

Description: DASH4D is a randomized, controlled feeding study that is testing the effects of 2 levels of sodium intake in 2 dietary patterns on blood pressure and other outcomes in 105 persons with type 2 diabetes. The trial will complete feeding in June 2024, at which time there will be opportunities for secondary data analyses.  Given the dearth of evidence on the impact of dietary factors on BP in persons with diabetes, we anticipate that results of this trial will potentially be quite influential.  

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: Yes 

Maximizing Respect and Improving Patient Outcomes in HIV and Substance Abuse (MaRIPHOSA)

Welch Center Investigators: Beach MC

Description: Ongoing data collection to establish a repository of audio-recorded patient-provider encounters in HIV care embedded within the HIV Clinical Cohort such that retrospective case-control analyses examining interpersonal factors associated with patient outcomes (e.g. dropping out of care, substance use relapse, etc.) can be conducted as these outcomes become apparent.

• Study Design: Observational Studies
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

Improving Patient Outcomes with Respect and Trust (IMPORT)

Welch Center Investigators: Beach MC

Description: Three-year cohort study of 280 adults and adolescents with sickle cell disease, including multiple psychological, behavioral, social and clinical outcomes including measures of pain and pain medication use, as well as patient experience of respect and trust in the healthcare system.

• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Enhancing Communication and HIV Outcomes (ECHO)

Welch Center Investigators: Beach MC, Cooper LA

Description: Observational database of 850 audio-recorded routine outpatient patient-provider encounters from 4 sites across the United States, that includes multiple behavioral and clinical measures including detailed substance use history, adherence to therapy, attitudes towards treatment, trust in the healthcare system, and experience of care.

• Study Design: Observational Studies, Health Services  
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No 

Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in Johns Hopkins Prenatal Care Practices

Welch Center Investigators: Bennett W, Wang NY, Coughlin J  

Description: We are conducting a pragmatic RCT to test a remotely delivered health coaching program in pregnant and postpartum women aimed at promoting healthy weight gain.

• Study Design: Clinical Trials
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: Yes

The Impact of Timing of Eating on Weight: A Multi-site Cohort Study Using the Daily24 Mobile Application (Daily24)

Welch Center Investigators: Bennett W, Zhao D, Clark J, Coughlin J

Description: We developed a mobile application for ecologic momentary assessment of timing of eating and sleeping and are implementing it in a large cohort (~1000) of patients enrolled from 3 health systems as part of the PCORNet Clinical Data Research Network.

• Health Conditions and Cross Cutting Themes and Other Domains: Cohort Study, mobile technology, obesity prevention
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: Yes

Electronic Media Powering positive health changes in youth: EMPower Study  

Welch Center Investigators: Brady, TM, Appel, L, Miller ER

Description: EMPower is a completed randomized clinical trial designed to test the effect of a behavioral intervention delivered by social media on weight, blood pressure and left ventricular mass among children with overweight and obesity.  We also aim to compare the effects of the intervention on hormonal regulators of (a) blood pressure, (b) growth, (c) adiposity, and on lipid risk factors.

Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Pediatric health, Obesity

• Study Design: Clinical Trials
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

ReNEW (Reversing the Negative CV effects of Weight) Clinic Cohort

Welch Center Investigator: Brady, TM

Description: The ReNEW clinic is a multidisciplinary clinic for children, adolescents and young adults with overweight/obesity and elevated blood pressure. Patients are recruited to enroll in this prospective, longitudinal clinic cohort study.  

Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Pediatric health, Obesity

• Study Design: Observational Study
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

Behavioral Risk Factors for Poor Vascular Health in Youth: The BeHealthY Study

Welch Center Investigators: Brady, TM, Appel, L

Description: This is a cross-sectional study investigating the association of diet quality and sodium intake on clinical and pre-clinical measures of cardiovascular health.  Participants are recruited from the ReNEW clinic and undergo detailed dietary analysis, study specific lab work, 24-hour ambulatory blood pressure monitoring, actigraphy and assessments of vascular stiffness and endothelial function.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Pediatric health, Obesity
• Study Design: Cross-sectional Study
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

Association of Mood with Risk for Atherosclerosis (The AuRA Study)

Welch Center Investigator: Brady, TM

Description: This is a cross-sectional study investigating the association of mood disorders and adverse childhood experiences on clinical and pre-clinical measures of cardiovascular health.  Participants are enrolled from the BeHealthY study (obese population without mood disorders), the CHAMPION trial (obese population with mood disorders), and the Pediatric Medical Psychiatric clinic (mood disorder patients with normal BMI).

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Pediatric health, Obesity, Mental health
• Study Design: Cross-sectional Study
• Opportunities for secondary analysis: No
• Opportunities for participating in study conduct: No

Rest Time before Blood Pressure Measurement Trial: The Best Rest Study

Welch Center Investigators: Brady, TM, Appel, L, Miller, ER, Matsushita, K, Ishigami, J, Charleston, J

Description: This is a RCT with a cross-over design to compare the effects on blood pressure of resting 0 or 2 minutes vs. 5 minutes (reference) before the initial blood pressure measurement.  It will also determine the effect of different rest times on blood pressure variability.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension
• Study Design: Clinical Trial
• Opportunities for secondary analysis: Maybe
• Opportunities for participating in study conduct: No

Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial  

Welch Center Investigators: Brady, TM, Appel, L, Miller, ER, Matsushita, K, Ishigami, J, Chasesrleston, J

Description: This is a RCT with a cross-over design that will compare the effects of cuff size (too small, too large) on automated blood pressure measurement.  

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension
• Study Design: Clinical Trial
• Opportunities for secondary analysis: Maybe
• Opportunities for participating in study conduct: No 

Action for Health in Diabetes (Look AHEAD)

Welch Center Investigators: Clark J, Maruthur N, Pilla S, Yeh, J

Description: The Action for Health in Diabetes (Look AHEAD) is a randomized trial comparing the effects of Intensive Lifestyle Intervention (ILI) focused on weight loss achieved through healthy eating and increased physical activity versus a control condition of Diabetes Support and Education (DSE) in overweight and obese individuals with type 2 diabetes. The Look AHEAD Extension (LA-E) will examine whether ILI, provided for 10 years during mid-life, has enduring benefits that persist beyond the period of the intervention for older individuals with diabetes.

• Health Conditions and Cross Cutting Themes and Other: Obesity, Type 2 diabetes, cardiovascular disease, aging, weight loss
• Domains Study Design: Clinical Trials, Observational Studies
• Opportunities for secondary analysis: Yes, including analysis of plasma/serum
• Opportunities for participating in study conduct: No

Improving Diabetes through Lifestyle and Surgery (IDeaLS)

Welch Center Investigators: Clark J, Maruthur N, Potter J

Description: This pilot randomized trial was designed to compare the effect of 3 weight loss interventions (medical weight loss, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) on glucose homeostasis and diabetes at approximately the same degree of weight loss (10%). Detailed measures of meal-stimulated glucose and gut hormones, as well as visceral fat and the microbiome were collected to help determine the differential mechanisms behind the effects.

• Health Conditions and Cross Cutting Themes and Other Domains: Obesity, bariatric surgery  
• Study Design: Clinical Trials
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

The Role of Time-Restricted feeding on obesity and cardio metabolic health (AHA –Obesity Center)

Welch Center Investigators: Clark J, Maruthur N, Bennet W, Appel L, Guallar E

Description: This grant funds an Obesity Center focused on investigating the effect of time-restricted feeding on cardiometabolic health.  It will also fund 3 fellows for 2 years of translational research each. The center includes a basic science project (PI Rex Ahima, Endocrinology), a clinical project (PI Nisa Maruthur) and a population project (PI Wendy Bennett).  

• Health Conditions and Cross Cutting Themes and Other Domains: Obesity, Circadian rhythm, cardiovascular risk
• Study Design: Clinical Trials, Population-based observational study
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No 

Achieving Blood Pressure Control Together (ACT Study)

Welch Center Investigators: Ephraim P, Cooper L, Carson K, Wang N-Y, Hill-Briggs F, Gudzune K, Charleston J, Crews D, Greer R, Thornton R

Description: The ACT Study was a 3-arm randomized trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African- American hypertensive patients' improved hypertension self-management and subsequent hypertension control. The study enrolled 159 patients with uncontrolled hypertension from an urban primary care clinic and randomly assigned them to receive: 1) an educational intervention lead by a community health worker (CHW) alone, 2) the CHW intervention plus a patient and family communication activation intervention, or 3) the CHW intervention plus a problem-solving intervention. The primary study outcome was blood pressure control at 12 months. Several biomedical, psychological, environmental, social, and demographic correlates and several mediators of hypertension control (e.g., self-monitoring and self-management behaviors, medication adherence) were assessed by patient self- report, and all primary care and CHW encounters were audio recorded.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health, Health Services Research and Patient Provider Communication, Kidney Disease
• Study Design: Clinical Trials, Health Services  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Reducing Disparities and Controlling Hypertension in Primary Care (ReD CHiP)

Welch Center Investigators: Cooper L, Carson K, Miller P, Greer R, Boonyasai T, Charleston J, Purnell T, Dalcin A, Aboumatar H, Thornton, R

Description: ReD CHiP was a large, pragmatic trial that tested the effects of 3 multi-level interventions (blood pressure measurement, patient care management, and provider communication skills training with race-stratified, hypertension dashboard) on racial disparities in blood pressure control at 6 primary care practices in the Baltimore area. The trial included over 40 primary care providers, 60 clinical staff, and 40,000 patients. Several trainees have conducted secondary analyses.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health, Health Services Research and Patient Provider Communication
• Study Design: Quality Improvement  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone (The RICH Life Study)

Welch Center Investigators: Cooper L, Appel L, Daumit G, Carson K, Crews D, Greer R, Hill-Briggs F, Miller E, Wang NY, Yeh HC, Boonyasai R, Charleston J, Purnell T, Daumit G, Ndumele C, Thornton R

Description: This is a pragmatic cluster randomized trial in which we will compare the effectiveness of clinic-based standard of care plus audit, feedback and education (SCP) to an intervention that uses a collaborative care team, a community health worker and specialist consultation to deliver contextualized, appropriately stepped care (CC/stepped care) for reducing disparities and improving patient-centered outcomes among patients with hypertension. Thirty primary care clinics, including Federally Qualified Health Centers, across Maryland will recruit 63 patients each (total=1,890). We will use patient and broad stakeholder engagement and apply principles of community-based participatory research to refine and adapt intervention protocols and materials to the needs of participating organizations, clinic sites, and populations. The main study outcomes are blood pressure control at 24 months, change in systolic blood pressure over 24 months, and change in patient activation over 24 months. Pre-specified subgroup analyses will test for differences in intervention effect across race/ethnicity, rural/urban residence, Medicaid/non-Medicaid status, and stepped care status. The project is also conducting an ancillary study assess the impact of the COVID-19 pandemic on households and individuals. Information will be gathered on a range of issues, including food insecurity, household socioeconomic status, and public benefit receipt and utilization prior to and in response to the COVID-19 pandemic.  

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension,Community Based Participatory Research,Health Behaviors and Lifestyle,Health Disparities and Social Determinants of Health,Health Services Resarch and Patient Provider Communication: COVID-19 Infection
• Study Design: Clinical Trials, Health Services  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS)

Welch Center Investigators: Crews D

Description: Prospective cohort study examining the differential influences of race and socioeconomic status on health outcomes.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension,Diabetes Mellitus and Obesity,Health Behaviors and Lifestyle,Health Disparities and Social Determinants of Health,Kidney Disease,Mental Illness and Substance Abuse
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Resiliency in Dialysis Initiation (ReDI)

Welch Center Investigators: Crews D

Description: Prospective study of older adults with advanced kidney disease who are initiating hemodialysis  

• Health Conditions and Cross Cutting Themes and Other Domains: Kidney Disease, Older Adults
• Study Design: Observational Studies
• Opportunities for secondary analysis: Potential
• Opportunities for participating in study conduct: Yes

Five, Plus Nuts and Beans for Kidneys

Welch Center Investigators: Miller E, Crews D, Carson K, Appel L, Cooper L, Charleston J, Yeh J, Dalcin A

Description: This study will test whether delivering nutritional advice to adopt a DASH-like diet and $30/week worth of fruits, vegetables, nuts and beans will reduce kidney damage in socioeconomically disadvantaged African Americans with hypertension and chronic kidney disease. Ancillary qualitative studies will examine participant experiences with the intervention.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Disparities and Social Determinants of Health, Kidney Disease
• Study Design: Clinical Trials, Qualitative Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients with End-Stage Kidney Disease

Welch Center Site Investigator(s): Crews D

Description: This multi-site study (Schwarze, M., PI, U-Wisconsin) will test the Best Case/ Worst Case intervention, a tool that nephrologists will use for communicating with older adult patients who are deciding whether to initiate dialysis. Outcomes will include initiation of dialysis and palliative care, quality of life, and intensity of treatment at the end of life.  

• Health Conditions and Cross Cutting Themes and Other Domains: Kidney Disease, Dialysis, Older Adults, Quality of Life, Health Literacy
• Study Design: Clinical Trials  
• Opportunities for secondary analysis: No  
• Opportunities for participating in study conduct: Yes

Disparities in Chronic Kidney Disease

Welch Center Investigators: Crews D, Purnell T

Description: This study will examine the association of race, ethnicity, access to specialty care and geographic location with kidney disease progression, associated costs and mortality among the Medicare and Medicaid population.  

• Health Conditions and Cross Cutting Themes and Other Domains: Kidney Disease, Health Disparities and Social Determinants of Health, Population Health, Specialty Care Access and Utilization
• Study Design: Retrospective Chart Review  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No

Barriers to Arteriovenous Fistula Use in Black Hemodialysis Patients

Welch Center Investigators: Crews D

Description: Despite national guidelines, Black dialysis patients are less likely to use a fistula than are whites. This proposal will examine multi-level factors that may explain racial disparities in fistula use.  

• Health Conditions and Cross Cutting Themes and Other Domains: Kidney Disease, Health Disparities and Social Determinants of Health, Population Health, Specialty Care Access and Utilization
• Study Design: Observational Studies, Qualitative Studies
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No 

Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE)  

Welch Center Investigators: Daumit G, Appel L, Wang NY, Dalcin A, Guallar E, Crum R, Charleston J, Gennusa J, Goldsholl S

Description: This was a NIMH-funded 18-month behavioral weight loss trial of 291 adults with serious mental illness in 10 sites in Maryland. It was a landmark trial that demonstrated persons with serious mental illness can lose with an appropriately tailored intervention.  

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Mental Illness and Substance Abuse, Health Behaviors and Lifestyles  
• Study Design: Clinical Trial  
• Opportunities for Secondary Analysis: Yes  
• Opportunities for participating in study conduct: No  

Comprehensive Cardiovascular Risk Reduction Trial in Persons with Serious Mental Illness (IDEAL)  

Welch Center Investigators Daumit G, Appel L, Wang NY, Miller E, Ford D, Dalcin A, Crum R, , Charleston J, Gennusa J, Goldsholl S  

Description: This NHLBI-funded community organization-based randomized clinical trial tested the hypothesis that an 18-month comprehensive, practical cardiovascular disease (CVD) risk reduction program was superior to control in improving cardiovascular health in persons with serious mental illness. We partnered with a large mental health organization and enrolled 269 adults with serious mental illness. Active intervention participants received individual CVD risk reduction behavioral counseling from a health coach, as well as nurse coordination with primary care providers to promote optimal management of CVD risk factors. The intervention group participants had a 12.7% relative reduction in the 10-year probability of a cardiovascular event, compared with the control group. These findings support the use of a behavioral counseling, care coordination, and care management intervention to substantially reduce cardiovascular health disparities in this high-risk population.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health, Mental Illness and Substance Abuse  
• Study Design: Clinical Trial  
• Opportunities for Secondary Analysis: Yes  
• Opportunities for participating in study conduct: No  

Statewide Implementation of Health Homes for Persons with Serious Mental Illness  

Welch Center Investigators Daumit G

Description: This NIMH-funded observational study used a combination of analyses of administrative claims data and interviews and surveys with stakeholders to examine the health home program in Maryland. The health home program provides enhanced care coordination services for persons with serious mental illness to better integrate somatic and behavioral health services. This project, along with other studies Dr. Daumit is conducting as part of her clinical trials to implement physical health interventions in mental health settings, and her NIMH P50 ALACRITY Center comprise a developing research program in implementation science.  

• Health Conditions and Cross Cutting Themes and Other Domains: Health Services Research and Patient Provider Communication, Mental Illness and Substance Abuse, Implementation Science  
• Study Design: Observational Studies, Health Services, Qualitative Study  
• Opportunities for Secondary Analysis: Yes  
• Opportunities for participating in study conduct: No  

Randomized Trial of a Healthy Weight Intervention for Youth with Serious Emotional Disturbance (CHAMPION)  

Welch Center Investigators Daumit G, Wang NY, Appel L, Dalcin A, Brady T, , Charleston J, Gennusa J, Goldsholl S

Description: This NIMH-funded randomized clinical trial designed and tested a healthy weight intervention for 120 youth ages 8 to 18 years old with mental illness with a body mass index at or above the 85th percentile. The active intervention group received a 12-month practical healthy weight program integrating weight management counseling and physical activity. The health coach delivering the program incorporated techniques to engage both youth and parents.

Health Conditions and Cross Cutting Themes and Other Domains: Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Mental Illness and Substance Abuse  

Study Design: Clinical Trial  

Opportunities for Secondary Analysis: Yes  

Opportunities for participating in study conduct: No

Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness (TRIUMPH)  

Welch Center Investigators Daumit G, Wang NY, Appel L, Miller E, Dalcin A, Ford D, Charleston J, Gennusa J, Goldsholl S  

Description: This NIMH-funded community health organization-based, randomized clinical trial tested an 18-month comprehensive tobacco smoking cessation program integrating exercise and weight counseling. The study included 192 adults living with serious mental illness interested in quitting smoking within 1 or 6 months. 26.4% receiving the intervention and 5.7% of the control group achieved smoking abstinence at 18 months, without significant weight gain. The project's results support implementation of extended-duration tobacco cessation treatment to reduce smoking rates and cardiovascular risk in this population with elevated smoking and obesity prevalence

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Health Behaviors and Lifestyle, Mental Illness and Substance Abuse  
• Study Design: Clinical Trial  
• Opportunities for Secondary Analysis: Yes  
• Opportunities for participating in study conduct: No  

The ALACRITY Center for Health and Longevity in Mental Illness (ALACRITY)  

Welch Center Investigators Daumit G, Gudzune K, Dalcin A, Yuan C, Wang N, Appel L, Cooper L, Goldsholl G, Gennusa J, Ibe C

Description: This NIMH-funded P50 Center uses cutting-edge transdisciplinary methods to advance short- and long-term strategies to reduce cardiovascular risk and premature mortality in persons with serious mental illness. The ALACRITY Center’s initial funding supported three core pilot research projects, as well as Methods Core projects and opportunities for pilot funding. Data collected over the course of the research projects is available for secondary analysis. Examples of the types of data collected for each of these projects include: demographics, knowledge of intervention topics, self-efficacy to complete intervention, evaluation of acceptability/appropriateness/feasibility of the intervention program, intervention delivery information, fidelity to intervention, and qualitative data related to the intervention. Other types of data may be available for secondary analysis, depending upon the project.  

The Core Pilot Research projects took place in a range of community mental health settings and tested innovative implementation strategies to support high-fidelity implementation of evidenced-based practices to reduce cardiovascular risk:  

• R34-1 ACHIEVE-D: Adapted an evidence-based weight loss intervention and tested strategies to increase implementation in community mental health programs.  
• R34-2 IMPACT: Promoted evidence-based tobacco smoking cessation treatment, which included tailored counseling and medication, in community mental health clinics.
• R34-3 RHYTHM: Used an Innovative Quality Improvement Process to Increase Delivery of Evidence-Based Cardiovascular Risk Factor Care in Community Mental Health Organizations.  

The Methods Core projects include:  

• Quantitative Methods: Contributed to advanced quantitative methods to support intervention scaleup, including: Informing the design of Sequential, Multiple Assignment, Randomized Trials (SMARTs), Evaluating the heterogeneity of treatment effects, and Assessing the generalizability of trials to target populations,  
• Systems Science: Built a systems model to characterize health impacts of implementing evidence-based interventions to decrease cardiovascular risk in persons with serious mental illness,  
• Evaluating Avatar-Assisted Training and Assessment of Motivational Interviewing  

In the next phase of the Center, we will amplify the Center’s impact through an enhanced focus on health equity, partnership engagement, methods innovations, and building capacity amongst mental health researchers and community partners to advance health equity for people living with serious mental illness. Through one signature (R01) project and three R34 research projects, we will rigorously plan and test implementation strategies that address all CVD risk factors and risk behaviors in persons with SMI in broad community settings. The Methods Core will build upon its earlier use of innovative, transdisciplinary approaches to support Center research. The Administrative Core will continue leading overall operations, and further grow capacity amongst researchers and community partners through training and partnerships.

Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Mental Illness and Substance Abuse, Health Disparities and Social Determinants of Health, Implementation Science, Health Services Research  

Study Design: Clinical Trial, Observational Study Health Services, Qualitative Study  

Opportunities for Secondary Analysis: Yes

Opportunities for participating in study conduct: Yes

Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies (DECIPHeR)  

Welch Center Investigators Daumit G, Yuan C, Gennusa J, Goldsholl S, Dalcin A, Wang NY, Appel L, Cooper L  

Description: This NHLBI UG3/UH3 funded study part of the national DECIPHeR Alliance will combine two evidence-based interventions (IDEAL and Life Goals) with different implementation strategies to improve the quality of care for cardiovascular disease risk factors among people with serious mental illness. The study is a collaboration between the Johns Hopkins ALACRITY Center and the University of Michigan. The study contains two phases. The first phase (UG3) sought input on different facets of the IDEAL Goals intervention from community stakeholders including from Community Working Groups. The second phase (UH3) compares the effectiveness of adding different implementation strategies (Coaching and Facilitation) to a standard implementation strategy on uptake and delivery of the IDEAL Goals intervention.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Mental Illness and Substance Abuse, Health Disparities and Social Determinants of Health, Implementation Science  
• Study Design: Cluster-randomized Type 3 hybrid implementation-effectiveness trial using a non-restricted sequential, multiple assignment randomized trial (SMART) design, Qualitative Study
• Opportunities for Secondary Analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Jackson Heart Study (JHS)

Welch Center Investigators: Golden S, Carson K, Echouffo-Tcheugui J  

Description: The Jackson Heart Study is a community-based, observational study of 5301 non- institutionalized adult African Americans 35-84 years old, except in the family cohort where those 21 to 34 years of age were eligible, recruited from urban and rural areas of three counties in the Jackson, Mississippi metropolitan area. Participants were enrolled from 4 sources: random, 17%, volunteer, 22%, currently enrolled in the ARIC Study, 30% and secondary family members, 31%. Data include medical history, physical examination, blood/urine analytes, physical activity, stress, coping and spirituality, racism and discrimination, socioeconomic position, and access to health care. At 12-month intervals, participants are contacted by telephone to confirm vital status, document interim medical events, hospitalizations, and functional status, and obtain additional sociocultural information. Following the baseline examination (2000-2004) there were two follow-up exams (2005-2008 and 2009-2013).

• Study Design: Observational Studies
• Opportunities for secondary analysis: Yes
• Opportunities for participating in study conduct: No

Multi-Ethnic Study of Atherosclerosis (MESA)

Welch Center Investigators: Golden S, Post W

Description: MESA is an ethnically diverse population-based sample of 6,814 men and women from four ethnic groups: non-Hispanic whites (NHW, 38%), African- Americans (AA, 28%), Chinese- Americans (CA, 12%), and Hispanic- Americans (HA, 22%). Participants were aged 45–84 years at baseline. It investigated the prevalence, correlates, and progression of subclinical CVD and risk factors that predict progression to clinically overt CVD, and that predict progression of subclinical disease itself. The cohort was recruited from six Field Centers throughout the United States and characterized with respect to coronary calcification using computed tomography, ventricular mass and function using magnetic resonance imaging, and other measures at baseline. Several subclinical disease measures were repeated in 4 subsequent examinations.

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Endocrinology
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Maybe 

Time-Restricted Intake of Meals Study (TRIM) 

Welch Center Investigators: Maruthur N, Clark J, Appel L 

Description: In this 12-week randomized feeding study among adults with prediabetes or diabetes not requiring medication treatment, we will evaluate the effect of eating earlier (time-restricted feeding) vs. later (usual feeding pattern) in the day on weight, glucose homeostasis, and blood pressure at 12 weeks. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

PAD research in ARIC 

Welch Center Investigators: Matsushita K, Coresh J, Selvin E, Jaar B, Ballew S 

Description: Peripheral artery disease (PAD) has been understudied despite its growing prevalence and impact on clinical outcomes and physical function. The ARIC study has been collecting data (e.g., ankle- brachial index and hospitalizations related to PAD) for PAD research and gives a unique opportunity to explore major risk factors of incident PAD over three decades of follow-up and the impact of PAD on various aspects of health. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Maybe 

ARICAC: CAC in ARIC 

Welch Center Investigators: Matsushita K, Blaha M, Coresh J, Ballew S, Mok Y 

Description: Coronary artery calcium (CAC) as well as extra-coronary calcium (ECC) were evaluated in ~2,300 ARIC participants at the ARIC visit 7 (2018-2019) when everyone was aged 75+ years. This projects aims to determine the value of CAC and ECC for guiding cardiovascular preventive therapies in 75-and-older populations. This study will also provide a unique opportunity to study healthy vascular aging. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Maybe 

PASOS: PAD study in the Study of Latino (SOL) 

Welch Center Investigators: Matsushita K, Schrack J, Ballew S, Mok Y 

Description: PASOS aims to extensively evaluate PAD (i.e., ankle-brachial index, toe-brachial index, and ankle artery waveforms) and objectively assess physical activity (1-week monitoring using Actigraph) in ~6,000 participants in SOL. The overarching goals are to determine the impact of PAD on physical activity and to examine the value of objectively measuring physical activity for diagnosing and classifying PAD. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Maybe  
• Opportunities for participating in study conduct: Maybe 

Washington County Health Initiative (WCHI) 

Welch Center Investigators: Matsushita K, Coresh J, Ballew S 

Description: The Washington County Health Initiative (WCHI) aims to utilize electronic medical records collected at Meritus Health to better understand the burden and pathophysiological process of important diseases such as heart failure, chronic obstructive pulmonary disease, diabetes mellitus, obesity, and mental health in Washington County. The ultimate goal is to derive targeted preventive strategies that are tailored to the region based on existing local data. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Diabetes Mellitus and Obesity 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Maybe  
• Opportunities for participating in study conduct: No 

Five, Plus Nuts and Beans for Kidneys 

Welch Center Investigators: Miller E, Crews D, Carson K, Appel L, Cooper L, Charleston J, Yeh J 

Description: This study will test whether delivering nutritional advice to adopt a DASH-like diet and $30/week worth of fruits, vegetables, nuts and beans will reduce kidney damage in socioeconomically disadvantaged African Americans with hypertension and chronic kidney disease. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Disparities and Social Determinants of Health, Kidney Disease 
• Study Design: Clinical Trials  
• Opportunities for secondary analysis: No  
• Opportunities for participating in study conduct: Yes 

The effects of a long-chain polyunsaturated fatty acid supplementation on biomarkers of kidney injury in adults with diabetes (Go Fish) 

Welch Center Investigators: Miller E, Appel L, Guallar E 

Description: Randomized placebo-controlled 2-period cross-over trial to test the effects of 4 g/d of n-3 PUFA supplementation on markers of glomerular filtration and kidney injury in adults with adult-onset diabetes and > trace amounts of proteinuria. 

• Health Conditions and Cross Cutting Themes and Other Domains: Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle, Kidney Disease 
• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Diet, exercise, and weight-loss intervention trial (DEW IT) 

Welch Center Investigators: Miller E, Appel L, Charleston J 

Description: This trial demonstrated that a comprehensive ”lifestyle” intervention can substantially lower blood pressure and improve blood pressure control in hypertensive overweight adults taking one antihypertensive agent. Specifically, the lifestyle intervention reduced mean 24-hour systolic blood pressure by 9.5 mm Hg and diastolic blood pressure by 5.3 mm Hg. 

• Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Dietary Approaches to Stop Hypertension (DASH) Diet effects on Serum Uric Acid (SUA) in adults with hyperuricemia and gout (DiGo) 

Welch Center Investigators: Miller E, Yeh J, Carson K, Appel L, Gelber A, Charleston J  

Description: In this (the Diet-Gout trial), randomized controlled trial (RCT) of 40 adults with gout or with hyperuricemia (SUA level ≥ 7mg/dL) who are not yet indicated for urate-lowering drugs (ULDs).  This trial has been funded by the Rheumatology Research Foundation. In this trial, we used a crossover design (N=44) to compare a dietitian-directed DASH diet vs. a usual “self-directed” diet on serum uric acid. Each period will last 4 weeks, separated by a 0–1-week wash-out period, The DASH-Plus intervention resulted in: increased self-reported consumption of fruits and vegetables, increased estimated intake of potassium, magnesium and vitamin C, and increased urine potassium excretion. However, there was no significant effect on SBP or DBP 

• Health Conditions and Cross Cutting Themes and Other Domains Study Design: Clinical Trials 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Five, Plus Nuts and Beans  

Welch Center Investigators: Miller E, Carson K, Appel L, Cooper L, Charleston J, Wang NY, Yeh J 

Description: This study will test whether delivering nutritional advice to adopt a DASH-like diet and $30/week worth of fruits, vegetables, nuts and beans will reduce blood pressure in socioeconomically disadvantaged African Americans with hypertension. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cardiovascular Disease and Hypertension, Community Based Participatory Research, Health Disparities and Social Determinants of Health, Kidney Disease 
• Study Design: Clinical Trials  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No 

The Effect of a Housing Mobility Program on Environmental Exposures and asthma morbidity among low-income minority children (MAP)

Welch Center Investigators: Pollack C 

Description: Working with a housing mobility program in Baltimore, this study examines whether moving neighborhoods is linked with changes in exposures in one's home environment and asthma outcomes. 

• Health Conditions and Cross Cutting Themes and Other Domains: Health Disparities and Social Determinants of Health 
• Study Design: Observational Studies  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Movember TrueNTH Intiative 

Welch Center Investigators: Pollack C 

Description: Through a series of linked projects, we are attempting to improve the care for prostate cancer survivors. Projects include creating a survivorship care plan and patient navigation services and an online intervention to improve sexual recovery. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cancer 
• Study Design: Clinical Trials  
• Opportunities for secondary analysis: No  
• Opportunities for participating in study conduct: Yes 

The effects of neighborhood poverty on health care utilization and spending for low- income adults and children: Linking the Moving to Opportunity participants to medical claims data Study 

Welch Center Investigators: Pollack C 

Description: By linking insurance claims and hospital discharge data with a large social experiment, this study attempts to make causal estimates on the association between health care utilization and neighborhood poverty. 

• Health Conditions and Cross Cutting Themes and Other Domains: Health Disparities and Social Determinants of Health 
• Study Design: Health Services 
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: No 

Patient-Centered Strategies to Reduce Disparities in Access to Kidney Transplantation 

Welch Center Investigators: Purnell T, Cooper L, Crews D, Segev D 

Description: This is a prospective cohort study of adults evaluated for a kidney transplant (KT) at Johns Hopkins Hospital. The primary goals of the study is to improve transplant education and address social determinants that influence disparities in access to KT using a stakeholder-engaged intervention approach. 

• Health Conditions and Cross Cutting Themes and Other Domains: Community Based Participatory Research, Health Behaviors and Lifestyle, Health Disparities and Social Determinants of Health, Health Services Research and Patient Provider Communication, Kidney Disease 
• Study Design: Observational Studies, Health Services, Qualitative Study 
• Opportunities for Secondary analysis: Yes 
• Opportunities for participating in study conduct: Yes 

Effects of the DASH diet on glucose patterns in adults with type 2 diabetes (DASH4D CGM) 

Welch Center Investigators: Selvin E; Appel L; Rebholz C; Pilla S; Fang M; Zeger S 

Description: It is unknown if the DASH eating pattern, a diet rich in fruits and vegetables, can improve glucose control and reduce glycemic variability in adults with type 2 diabetes. This NIH R01 ancillary study to the DASH4D Trial is designed to address this question using a randomized clinical trial design. The results of this study will inform dietary recommendations in patients with diabetes. 

• Study Design: Randomized clinical trial  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

The Atherosclerosis Risk in Communities (ARIC) Study 

Welch Center Investigators: Selvin E; Matsushita K; Rebholz C; Sharrett R; Platz E; Rooney M; Fang M 

Description: Examines the etiology and natural history of atherosclerosis, cardiovascular disease, and aging related disease in a large community-based cohort. Hopkins investigators lead a wide range of ancillary studies on, diabetes, kidney disease, biomarkers, and cancer. ARIC recruited nearly 16,000 participants ages 45-65 years in 1986-1988 and follow-up continues with regular clinic visits, semi-annual telephone calls about health status and review of all hospitalizations with adjudication of cardiovascular events and dementia.  The ARIC specimen bank includes over 2 million vials which enables innovative ancillary studies. All ARIC data reside on the local Hopkins network and are available for secondary data analysis projects on a wide range of exposures and health outcomes. Dr. Frank Lin and Josef Coresh (emeritus faculty at JHU and professor at NYU) lead the related Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS) which is focused on identifying risk factors for cognitive decline and dementia. Substudies of ARIC-NCS  focus on brain amyloid deposition, MRI imaging, and hearing loss. ARIC NCS includes all ARIC participants. 

• Study Design: Observational  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes

Clinical relevance of glucose patterns in older adults (ARIC CGM Visit 9) 

Welch Center Investigators: Selvin E; Echouffo-Tcheugui JB; Fang M; Zeger S 

Description: Diabetes is common in older adults and associated with major adverse health outcomes. State-of-the art continuous glucose monitoring (CGM) technology provides a novel means to rigorously characterize glucose patterns, but this technology has rarely been used in older adults. This project will provide evidence-based guidance regarding the use and interpretation of continuous glucose monitoring in older adults. 

• Study Design: Observational  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Glucose instability and neurocognitive outcomes in older adults (ARIC CGM Neuro) 

Welch Center Investigators: Selvin E; Echouffo-Tcheugui JB; Fang M; Zeger S 

Description: To investigate the link between glucose instability, diabetes, and neurocognitive outcomes in older age in ARIC participants. This study aims to characterize specific glucose patterns in old age, evaluate associations of glucose patterns with certain symptoms (for example, dizziness, difficulty concentrating, vision disturbances), and examine associations of diabetes and glucose patterns with various neurocognitive outcomes including brain imaging, cognition, and dementia. 

• Study Design: Observational  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Glucose patterns and cardiac arrhythmias in older adults with diabetes  

Welch Center Investigators: Selvin E; Echouffo-Tcheugui JB; Rooney M; Zeger S 

Description: This project will provide evidence-based guidance regarding how low, high, and variable glucose may contribute to the occurrence of cardiac arrhythmias and subsequent health outcomes in the setting of diabetes. To achieve this goal, this study involves the placement of continuous glucose monitoring sensors and leadless “patch” ECG monitoring in ARIC participants and new recruitment of adults with diabetes aged 50 years and older to assess coinciding variations in glycemia and cardiac rhythm.  

• Study Design: Observational  
• Opportunities for secondary analysis: Yes  
• Opportunities for participating in study conduct: Yes 

Performance of Novel Cardiac Biomarkers in the General US Population (FNIH Cardiac Biomarkers) 

Welch Center Investigators: Selvin E; Fang M; Rooney M; Echouffo-Tcheugui JB; Brady T  

Description: This study, funded by a grant from the Biomarkers Consortium of the Foundation for the National Institutes of Health, is being undertaken to understanding the distribution, determinants, and mortality implications of novel cardiac, glycemic, and kidney biomarkers in the general US population including children and adults. We measured high sensitivity cardiac troponin T, high sensitivity cardiac troponin I (three different assays), glycated albumin, cystatin C, and beta-2 microglobulin in >23,000 stored blood samples collected from participants in the National Health and Nutrition Examination (NHANES) 1999-2004 survey. All assays have been completed and these data are available for secondary data analysis projects. 

• Study Design: Observational  
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

HYperglycemic Profiles iN Obstructive Sleep Apnea (HYPNOS) Biomarkers Study 

Welch Center Investigators: Selvin E; Rooney M 

Description: HYPNOS is a completed randomized clinical trial of treatment of sleep apnea and measures of glycemic status and cardiometabolic health in persons with type 2 diabetes. Cardiometabolic biomarkers were measured in stored blood samples in all HYPNOS and these data are available for secondary data analysis projects. 

• Study Design: Clinical Trial 
• Opportunities for secondary analysis: Yes 
• Opportunities for participating in study conduct: No 

Family-Oriented Diabetes Prevention: Augmenting the Diabetes Prevention Program 

Welch Center Investigators: Venkataramani M, Maruthur N 

Description:  The burden of type 2 diabetes is growing among children, especially in low-income and minority communities, and addressing lifestyle-associated risk factors may be an effective strategy for diabetes prevention. The National Diabetes Prevention Program lifestyle intervention has been proven to be effective in preventing diabetes among high-risk adults, and through this work, we will augment the program with child-related content that would enable caregivers (parents and guardians) to address lifestyle-associated diabetes risk factors in children. We will do this through conducting qualitative in-depth interviews of prior DPP participants to obtain their insights and guidance regarding content and structure of a family-oriented DPP and conducting a pilot randomized controlled trial with a focus on feasibility and acceptability of the intervention. The efforts would result in a family-oriented diabetes prevention program that could benefit both high-risk children and their caregivers, and reduce the burden of type 2 diabetes across generations.  

• Health Conditions and Cross-Cutting Themes and Other Domains: Diabetes Mellitus and Obesity, Health Behaviors and Lifestyle 
• Study Design: Qualitative Research, Intervention 
• Opportunities for secondary analysis: No 
• Opportunities for participating in study conduct: Yes 

Metformin and Lifestyle Intervention in Cancer Survivors (SPIRIT) 

Welch Center Investigators: Yeh HC, Appel L, Miller ER, Wang NY, Maruthur N, Charleston J, Dalcin A, Tseng E, Mueller N 

Description: This RCT examines the effects from metformin or behavioral weight loss to reduce IGF-1 in cancer survivors in Baltimore metro area. 

• Health Conditions and Cross Cutting Themes and Other Domains: Cancer, Obesity, Health Behaviors and Lifestyle 
• Study Design: Clinical Trials 
• Opportunities for Secondary analysis: Yes 
• Active Opportunities: No 

Behavioral Weight Loss for Overweight or Obese Cancer Survivors in Maryland: ASPIRE Study 

Welch Center Investigators: Yeh HC, Appel L, Wang NY, Charleston J, Dalcin A  

Description: The objective of the ASPIRE study is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The intervention will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors. 

• Health condition: Obesity, cancer, behavioral and lifestyle 
• Study design: pragmatic trial Opportunities for secondary analysis: Yes 
• Active opportunities: No 

Behavioral Weight Loss Opportunities for Cancer Survivors with Overweight or Obesity in Maryland: A Randomized Trial with Adaptive Interventions (Helpline for Weight Loss) 

Welch Center Investigators: Yeh HC, Appel L, Wang NY, Charleston J, Dalcin A , Maruthur N 

Description:  The objective of the Helpline trial is to determine the comparative effectiveness of two active, multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goals in the initial intervention period (termed early non-responders). 

• Health condition: Obesity, cancer, behavioral and lifestyle 
• Study design: randomized clinical trial; adaptive intervention  
• Opportunities for secondary analysis: No  
• Active opportunities: Yes  

Groceries Plus Multi-Component Lifestyle Intervention for Adults with Hypertension and Type 2 Diabetes Residing in Urban Food Deserts (DASH-Life Trial)  

Welch Center Investigators: Yeh HC, Crews D, Appel L, Wang NY, Charleston J, Dalcin A, Tseng E, Echouffo-Tcheugui J, Carson K  

Description: DASH-Life is to pilot-test a 2-arm, 6-month tailored groceries plus lifestyle intervention for adults with hypertension and type 2 diabetes residing in food deserts—a population at very high risk for adverse cardiometabolic health outcomes. 

• Health condition: diabetes, hypertension, diet, and behavioral 
• Study design: RCT 
• Opportunities for secondary analysis: No 
• Active opportunities: Yes