DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
NATIONAL INSTITUTE OF NURSING RESEARCH

NIH SPECIAL EMPHASIS PANEL ON
INTERVENTION STUDIES IN CHILDREN AND ADOLESCENTS
TO PREVENT CARDIOVASCULAR DISEASE

MINUTES OF MEETING
September 8-9, 1997

The meeting of the NIH Special Emphasis Panel on Intervention Studies in Children and Adolescents to Prevent Cardiovascular Disease was convened on September 8-9, 1997, at 8:20 a.m., at the Holiday Inn, Old Town, Alexandria, Virginia. In accordance with Public Law 92-463, the meeting was open to the public, from 8:20 a.m. on September 8 to adjournment at 11:45 a.m. on September 9. Dr. Ronald Lauer presided as Chair.

PANEL MEMBERS PRESENT

Ronald Lauer, M.D. (Chair), Claude Bouchard, M.D.; Yvonne Bronner Sc.D., R.D.; William H. Dietz, M.D., M.P.H.; Laura Hayman, Ph.D., F.A.A.N.; Martha N. Hill, R.N., Ph.D.; Peter O. Kwiterovich, Jr., M.D.; Russell R. Pate, Ph.D.; Ronald J. Prineas, M.D., Ph.D.; James Sallis, Ph.D.; Linda Van Horn, Ph.D., R.D.; Matthew W. Gillman, M.D., S.M.

MEMBERS OF THE PUBLIC PRESENT

Ellen Beck, Health Care News Server; Shiriki Kumanyika, Ph.D., M.P.H., National Heart, Lung, and Blood Advisory Council (NHLBAC) representative; Judith H. LaRosa, Ph.D., R.N., National Advisory Council for Nursing Research (NACNR) representative; Rick Petosa, Ph.D., CHES., Ohio State University; Reginald L. Washington, M.D., NHLBAC representative

FEDERAL EMPLOYEES PRESENT

Denise G. Simons-Morton, M.D., Ph.D. (Co-Executive Secretary, NHLBI); Hilary D. Sigmon, Ph.D., R.N. (Co-Executive Secretary, NINR); Lawton Cooper, M.D. (NHLBI); Jeffrey A. Cutler, M.D., M.P.H. (NHLBI); Darrell L. Ellsworth, Ph.D. (NHLBI); Abby Ershow, Ph.D. (NHLBI); Marguerite Evans, M.S., R.D. (NHLBI); Michael Horan, M.D. (NHLBI); Eva Obarzanek, Ph.D., R.D. (NHLBI); Gail Pearson, M.D., Sc.D. (NHLBI); Beth Schucker (NHLBI); Dan S. Sharp, Ph.D. (NHLBI); Mario Stylianou (NHLBI); Elaine J. Stone, Ph.D., M.P.H. (NHLBI); Carolyn Voorhees, Ph.D. (NHLBI); Ed Wagner, M.D. (OD/NIH).

OPEN MEETING

I. Call to Order

Dr. Simons-Morton called the meeting to order by stating the purpose of the meeting, which was to (a) recommend future directions for NHLBI and NINR research on intervention studies in children and adolescents to prevent cardiovascular disease, (b) review potential initiatives, and (c) identify additional or alternative topics for study.

II. Review of Confidentiality and Conflict of Interest Procedures

Dr. Simons-Morton reviewed the policies and procedures regarding confidentiality and avoidance of conflict-of-interest situations. The panel members signed the requisite form.

III. Discussion of Research Needs and Proposed Initiatives

The panel discussed six research areas under two main topics, as follows: I. Primary Prevention Through Clinical Treatment of Elevated Risk Factors (Medication Treatment for Dyslipidemia and Hypertension, Delivery of Clinical Preventive Services); II. Primordial and Primary Prevention Relevant to Public Health (Obesity Prevention, Prevention of Hypertension, Intervention Approaches for Improving Diet and Increasing Physical Activity, Other Issues: Nutrition and Diet).

In its discussions, the panel specifically reviewed the timeliness and design of five proposed initiatives for intervention research. The presentations and discussions of research areas and initiatives were preceded by a review of the influences and preventive interventions possible throughout the natural history of cardiovascular disease (CVD) and brief reports on NHLBI- and NINR-supported studies relevant to preventing CVD in children and adolescents. The panel also addressed the current status of intervention studies in this population and considered gene environment interactions for hypertension, dyslipidemia, and obesity.

The panel agreed that CVD is influenced by genetic, environmental, and behavioral influences that can begin at conception and develop throughout life. They also noted that interventions in adults have been shown to prevent or reduce these influences and thereby reduce the morbidity and mortality associated with CVD. However, whether prevention or reduction of CVD risk factors results in prevention of the onset or reduction of the development of CVD in children or adolescents is not known. Whether interventions during childhood and adolescence can prevent the development or progression of CVD in adults also is not known. Existing data from observational and intervention studies suggest that longitudinal multidisciplinary and multifactor interventions that incorporate genetic, biological, and behavioral perspectives could be effective in preventing or reducing subsequent CVD in children and adolescents and may yield long-term benefits.

The panel reviewed five potential initiatives. Each initiative was viewed favorably and further clarification or modification was suggested in areas of recruitment, target population and eligibility, intervention, measurement, and/or outcomes. The proposed intervention studies are focused on specific CVD risk factors and are targeted either to children and adolescents already at risk for CVD, to those at risk for developing CVD risk factors, or to a broader general population to prevent development of CVD factors. The topics are as follows:

• Cholesterol and Hypertension Intervention in Youth Program: to evaluate the efficacy and safety of lipid-lowering and antihypertensive drugs
  
  
• Obesity Prevention Approaches in African-American Girls: to test the effectiveness of intervention approaches to prevent excessive weight gain during the high-risk transitional period from pre-puberty through puberty in African-American girls who are at risk for developing obesity
  
  
• Prevention of High Blood Pressure by Diet in Infancy: to test whether diet in infancy affects blood pressure in infancy as well as later in childhood and adolescence
  
  
• Prevention of High Blood Pressure in African-American Young Adults: to test the effectiveness of a combination of lifestyle recommendations on preventing the rise in blood pressure with age in order to prevent hypertension in African-American young adults
  
  
• Prevention of Physical Activity Decline in Adolescent Girls: to test the combination of school and community agency interventions to reduce the decline in physical activity levels among adolescent girls. Inclusion of boys was also discussed.
  

The overall aim of these intervention studies is to identify safe and effective interventions to prevent or reduce CVD risk factors in children and adolescents. In addition to these studies, the panel suggested other research topics that are needed which could be developed into initiatives. These were as follows:

• Prevention and reduction of early cardiovascular pathology in children at very high risk of CVD
  
  
• Strategies to enhance dietary and physical activity interventions by physicians and other health care providers in clinical practice settings
  
  
• Effects of vitamin supplementation on homocysteine levels
  
  
• Effects of macronutrients and micronutrients on blood pressure levels after infancy
  

The panel also identified several broad issues for further research. These included:

• Measurement and intervention methods. Topics include evaluating the optimal balance between population-based and intensive, individual interventions; identifying subclinical and functional measures of early CVD pathology; and developing and refining the methodology (and markers) for measuring diet and physical activity.
  
  
• Diet and physical activity as risk factors for CVD. Topics include identifying the determinants (especially environmental determinants) of individuals' dietary behaviors and physical activity levels (through observational studies); studying the tracking of individuals' diet and physical activity behaviors; assessing the effects of fat-modified foods on individuals' nutritional status and individual's adherence to lower-fat diets; and evaluating the influence of a mother's nutrition on her offspring's cardiovascular risk.
  
  
• High-risk behaviors in high-risk groups. Topics include identifying the determinants of high-risk, lifestyle behaviors of adolescents and young adults, especially in minority (e.g., African-Americans, Hispanics) populations of various socioeconomic levels and lower socioeconomic status populations.
  
  
• Gene environment interactions. Topics include incorporating genetic issues (e.g., measurement of genotypes) into intervention studies and examining effects of environmental determinants on individuals with different genetic profiles and predispositions.
  

Regarding research support strategies, the panel encouraged several considerations. These include:

• Funding longer-term studies to examine the lasting effects of preventive interventions.
  
  
• Funding intervention development.
  
  
• Funding a broader range of study designs for testing environmental interventions.
  
• Convening a workshop on the state of the science of measures of early subclinical and functional pathology in atherosclerosis.
  
  
• Using Small Business Innovation Research (SBIR) awards to re-form and package intervention materials (e.g., smoking cessation information) for application in communities and health care settings.
  
  
• Funding studies to test approaches for disseminating effective programs.

The meeting was adjourned at 11:45 a.m. on September 9, 1997.

CERTIFICATION

I hereby certify that the foregoing minutes are accurate and complete.

Ronald Lauer, M.D.
Chair
Special Emphasis Panel

Denise G. Simons-Morton, M.D.
Co-Executive Secretary
Special Emphasis Panel

Hilary D. Sigmon, Ph.D., R.N.
Co-Executive Secretary
Special Emphasis Panel

Last Updated April 2011