Northwestern University Feinberg School of Medicine

Department of Preventive Medicine

Closed Clinical Trials

CARDIA

The Coronary Artery Risk Development in Young Adults (CARDIA) Study 

Northwestern Principal Investigator: Donald Lloyd-Jones, MD, ScM


The Coronary Artery Risk Development in Young Adults (CARDIA) Study is a study examining the development and determinants of clinical and subclinical cardiovascular disease and their risk factors.   It began in 1985-6 with a group of 5115 black and white men and women, aged 18-30 years, in four sites located throughout the U.S., including Birmingham, AL, Chicago, IL, Minneapolis, MN, and Oakland, CA.  These same participants were asked to participate in nine follow-up examinations over the course of the past 30 years.  While the specific aims of each examination have varied, data have been collected on a variety of factors believed to be related to heart disease.  These include conditions with clear links to heart disease such as blood pressure, cholesterol and other lipids, as well as glucose.  Data have also been collected on physical measurements such as weight and body composition, in addition to lifestyle factors such as dietary and exercise patterns, tobacco and alcohol use, behavioral and psychological variables, medical and family history, and other variables (e.g., insulin).  In addition, subclinical atherosclerosis and myocardial remodeling have been measured via echocardiography, chest and abdominal CT scans, and carotid ultrasounds at various time points.  A brain MRI was performed on a subset of participants during the last two exams.  The CARDIA study is continuing to collect information from participants on a semi-annual basis with the goal of continuing the clinical exams every five years.  

INTERMAP

Metabolic Pathways Underlying the Contrasting Sodium-BP and DASH/OmniHeart-BP Relationships

Northwestern Principal Investigators: Linda Van Horn, PhD, RD and Jeremiah Stamler, MD


The International Study of Macro-and Micro-Nutrients (INTERMAP) is a basic epidemiological investigation of relationships between micro- and macronutrient intakes, timed 24-hour urinary biochemistry and metabolic phenotypes, and BP. Data was originally collected from 1997-1999 on 4,630 women and men ages 40-59 (including metabolomics data) from diverse population samples in USA (N=2,164), People’s Republic of China (PRC, N=832), Japan (N=1,138) and UK (N=496) at four visits. Standardized quality-controlled data collection included eight BP measurements (two per visit); four interviewer-administered in-depth multi-pass 24-hr dietary recalls providing data on daily intake of 83 nutrients/person; questionnaire data on occupation/education/other sociodemographic traits, past and family medical history, medication use, special diet by type, dietary supplements, smoking, alcohol use (obtained with each of the four 24-hr dietary recalls, plus two histories of daily intake during the preceding seven days), data on other possible confounders, including for women on parity/menopausal status/estrogen use; height and weight measurement at two visits; two timed 24-hr urine collections on average 3 weeks apart, the first between visits 1 and 2, the second between visits 3 and 4. Urine specimens are stored in the London Metabolomics Laboratory, Imperial College London in -80°C freezers. The London Laboratory completed urinary metabolome-wide H NMR spectroscopic profiling of urine specimens from both first and second 24-hr urine collections.

The General Aim of the study is to advance knowledge of biochemical pathways involved in BP regulation by identifying urinary metabolic phenotypes associated with 1) the direct effect on BP of high Na intake, and 2) inverse BP effect (BP reduction) of the DASH/OmniHeart-protein eating pattern. To achieve this aim, we will identify and quantify the key metabolites related to these contrasting influences on BP, and will use state-of-the-art chemometrics, statistical spectroscopy, computational networks and pathway modeling tools to identify and map de novo pathways associated with Na and DASH/OmniHeart-protein and BP. We will then test and validate in external data the INTERMAP derived metabolites and pathways using available dietary and urinary data from the OmniHeart Trial, Urinary Sodium Study (USS), and follow-up data in the INTERMAP China Prospective (ICP) Study. The ultimate goal is to develop more focused and effective strategies for population-wide BP lowering through improved non-pharmacologic approaches (primarily nutritional), and to identify potential new targets for drug treatment.

For more information, please visit clinicaltrials.gov.

MESA

The Multi-Ethnic Study of Atherosclerosis (MESA) Study

Northwestern Principal Investigator: Kiang Liu, PhD


The Multi-Ethnic Study of Atherosclerosis (MESA) is a study of the characteristics of subclinical cardiovascular disease (disease detected non-invasively before it has produced clinical signs and symptoms) and the risk factors that predict progression to clinical cardiovascular disease or progression of the subclinical disease. MESA researchers study a diverse, population-based sample of 6,814 asymptomatic men and women aged 45-84 from six field centers across the United States, including Northwestern University, Department of Preventive Medicine.

Approximately 38 percent of the MESA participants are white, 28 percent African-American, 22 percent Hispanic, and 12 percent Asian, predominantly of Chinese descent. The first examination took place over two years, from July 2000-July 2002. It was followed by three examination periods that were 17-20 months in length, and a fifth exam April 2010 – January 2012. The sixth exam began in 2016 and is currently being conducted.  As part of the in-person examination, a variety of physical assessments and questionnaires are completed, including medical history, physical function, physical activity, anthropometry, blood pressure, current medications, echocardiogram, spirometry, cognitive function, and blood collection to determine cardiovascular biomarkers and genetic information.  In addition, MESA participants are invited to participate in a clinical trial, INVITE, testing the characteristics associated with Vitamin D levels.  

The MESA study continues to make important contributions to our scientific understanding of disease.  To date MESA has published over 1,100 papers!

MOMFIT

MOMFIT (Maternal-Offspring Metabolics: Family Intervention Trial)

Principal Investigators: Linda Van Horn, PhD, RD and Alan Peaceman, MD


Funding Source: National Heart Lung and Blood Institute and National Institute of Diabetes, Digestive and Kidney Diseases , IRB#: STU00053566

Lifestyle Interventions For Expectant Moms (LIFE-Moms) is a consortium comprised of seven clinical centers, a Research Coordinating Unit and NIH program staff.  The overall goal of the Consortium is to identify effective behavioral and lifestyle interventions that will improve weight, glycemic control and other-pregnancy-related outcomes in obese and overweight pregnant women, and determine whether these interventions reduce obesity and metabolic abnormalities in their children.  Each clinical center conducts its own trial.The objective of the collaboration is to maximize the value of the individual trials by identifying core measures collected across all seven studies and ensuring consistency of procedures, certain eligibility criteria, definitions and data collection. 

PROTOCOL SYNOPSIS

Objective: To test, in 300 ethnically diverse overweight /obese pregnant women, a behavioral intervention aimed at controlling gestational weigh gain through recommended diet, activity and lifestyle changes delivered during pregnancy and the post-partum period.

Primary Hypothesis: Gestational weight gain will be reduced in the Intervention Group vs. Usual Care (control) group.

Description of intervention: The MOMFIT intervention will use the modified DASH diet and moderate physical activity delivered within individual visits and group coaching sessions. Electronic self-monitoring will be implemented via smartphone and Internet access, along with ongoing feedback from a lifestyle coach.

Design Summary: Three hundred overweight and obese ethnically diverse pregnant women will be randomly assigned to the MOMFIT intervention group or Usual Care control group. The intervention will be initiated more intensively in the first and second trimester with continued support and telephone coaching through one year post-partum. Maternal assessment/outcomes visits will be conducted at baseline (9-15), 24-27 and 35-36 weeks of gestation, and 6 and 52 weeks post delivery. Infant visits will occur at birth, 6 and 52 weeks of age.

Primary Outcome: Gestational weight gain

Secondary Outcomes:

Mother:

Offspring:

Study Population and Eligibility Criteria: Participants will be recruited from racially, ethnically and socio-economically diverse population of pregnant women receiving prenatal care at Prentice Women’s Hospital, Chicago IL.

Inclusion criteria for MOMFIT that are not LIFE-Moms core: BMI upper cutoff (<40); age upper cutoff (45)

Exclusion criteria for MOMFIT that are not LIFE-Moms core: IVF conception/ovulation induction w/ gonadotropins, weight gain of >15 pounds from reported pre-pregnancy weight, current smoker, enrollment in a weight loss program within 3 months of conception, history of alcohol or drug abuse within 5 years, no access to internet and / or smartphone, unable to attend intervention/follow-up visits, unwilling/unable to commit to self-monitoring data collection, unable to complete intervention program, presence of any condition that limits walking or following diet recommendations, not fluent in English.

Clinicaltrials.gov: NCT01631747

Additional information on the Consortium and individual trials is located on the

LIFE-Moms website: https://lifemoms.bsc.gwu.edu/web/lifemoms/clinical-trials-summaries

Funded by NIDDK, NHLBI, NICHD, NCCAM, ORWH and OBSSR.

Women's Health Initiative (WHI)

Principal Investigator: Linda Van Horn, PhD, RD


The Women's Health Initiative (WHI) is a long-term national health study focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.  Launched in 1993, the WHI enrolled 161,808 women aged 50-79 into one or more randomized Clinical Trials (CT), testing the health effects of hormone therapy (HT), dietary modification (DM), and/or calcium and Vitamin D supplementation (CaD) or to an Observational Study (OS).  At the end of the initial study period in 2005, WHI Extension Studies (2005-2010, 2010-2020) continued follow-up of all women who consented.  

This groundbreaking study changed the way health care providers prevent and treat some of the major diseases impacting postmenopausal women.  It has been estimated that results from the WHI Hormone Trials have saved $35.2 billion in direct medical costs in the US alone.  To date, WHI has published over 1,400 articles and approved and funded 289 ancillary studies

The WHI had two major parts: a randomized Clinical Trial and an Observational Study. The randomized controlled Clinical Trial (CT) enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components. The components are:

Hormone Therapy Trials (HT): This component examined the effects of combined hormones or estrogen alone on the prevention of coronary heart disease and osteoporotic fractures, and associated risk for breast cancer. Women participating in this component took hormone pills or a placebo (inactive pill) until the Estrogen plus Progestin and Estrogen Alone trials were stopped early in July 2002 and March 2004, respectively. All HT participants continued to be followed without intervention until closeout.

Dietary Modification Trial (DM): The Dietary Modification component evaluated the effect of a low-fat and high fruit, vegetable and grain diet on the prevention of breast and colorectal cancers and coronary heart disease. Study participants followed either their usual eating pattern or a low-fat dietary pattern.

Calcium/Vitamin D Trial (CaD): This component began 1 to 2 years after a woman joined one or both of the other clinical trial components. It evaluated the effect of calcium and vitamin D supplementation on the prevention of osteoporotic fractures and colorectal cancer. Women in this component took calcium and vitamin D pills or a placebo.

The Observational Study (OS) is examining the relationship between lifestyle, health and risk factors and specific disease outcomes. This component involves tracking the medical history and health habits of 93,676 women. Recruitment for the observational study was completed in 1998 and participants were followed for 8 to 12 years.

The Fred Hutchinson Cancer Research Center in Seattle, WA serves as the WHI Clinical Coordinating Center for data collection, management, and analysis of the WHI. The WHI Clinical Trial and Observational Study were conducted at 40 Clinical Centers nationwide. Recruitment began in September 1993 and continued through October 1998 for the CT. The OS enrollment continued through December 1998. Closeout of the WHI CT occurred between October 2004 and March 2005.

WHI Extension Studies continued follow-up of consenting participants, the first consenting participants from each of the original WHI study components for an additional five years (2005-2010) of follow-up, and the second consenting participants from the first Extension Study for an additional five years (2010-2015). In 2015, WHI was awarded additional funding to continue follow-up of participants through 2020. Annual updates on health outcomes are collected by mail from the participants enrolled in each Extension Study..

Visit the Women’s Health Initiative website for descriptions of the study’s design, procedures, components, outcomes, and related publications.