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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
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