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National Growth and Health Study (NGHS)

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ClinicalTrials.gov Identifier: NCT00005132
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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Brief Summary:
To determine if the Black-white differences in the development of obesity in pubescent females were due to differences in psychosocial, socioeconomic and other environmental factors. Also, to determine whether differences in the development of obesity led to Black-white differences in other coronary heart disease risk factors, such as blood pressure and serum lipids.

Condition or disease
Cardiovascular Diseases Heart Diseases Obesity Coronary Disease Hypertension

Detailed Description:

BACKGROUND:

Although not all scientists agree that obesity is an independent risk factor for coronary heart disease, it may be a strong univariate predictor of coronary heart disease, and impacts on coronary heart disease through at least some of its relationships with other risk factors: positive association with blood pressure, inverse association with high density lipoprotein cholesterol (HDLC), positive association with triglyceride and very low density lipoprotein cholesterol (VLDLC), and a positive association with hyperglycemia and diabetes. A number of these have been shown to be major coronary heart disease risk factors. Prevention of obesity, or weight reduction towards desirable body weight may reduce the incidence of coronary heart disease and some of its risk factors. There is evidence to suggest that once obesity begins and/or advances in childhood, it will track into adulthood, with a reasonably high level of certainty. Obesity becomes progressively more difficult to treat with maturation to adulthood. Thus, better understanding of the pathophysiology of obesity in late childhood and early adolescence should, in the long-run, provide the basis for effective prevention or intervention programs in order to have a long-range impact upon the consequence of obesity. The age group 9 and 10 at entry has been selected to assure that many of the individuals are enrolled prior to puberty, and followed through this transition period when obesity becomes more apparent among Black adolescent females than among white.

Support for this research grew out of recommendations made at the Working Conference on Coronary Heart Disease in Black Populations held in September 1983 and sponsored by the NHLBI. The group recommended this research to identify the physiological and/or behavioral factors which contribute to obesity in Black females. In addition, the 1981 Report of the Working Group on Arteriosclerosis of the NHLBI stated that research is needed to characterize the behaviors that create and maintain caloric imbalance. The initiative was approved by the September 1984 National Heart, Lung, and Blood Advisory Council and the Request for Proposals was released in November 1984.

The NGHS I was initiated in 1985 as a contract-supported program with three field centers and a coordinating center. Annual exams were conducted at baseline and through the years of follow-up. The study was renewed by means of the cooperative agreement mechanism in 1992 as the NGHS II to permit two additional years of follow-up exams. The study was again renewed in 1994 as NGHS III to continue annual examinations.

DESIGN NARRATIVE:

In this longitudinal study, there were a baseline examination and annual examinations. Data collected included: physical examination; anthropometric measurements; dietary information including food pattern and nutrient intake; physical activity; lipid, lipoprotein, and apolipoprotein profiles; family socioeconomic status; and psychosocial information. The study was renewed twice to continue the longitudinal investigation until the subjects reached the age of 19 to 20. Following the girls until that age allowed the documentation of the transition in risk factors when Black girls no longer have a cardiovascular risk advantage and to study the factors surrounding the transition. The longer follow-up also allowed for studies on the influence of smoking on body weight and the relationship of adolescent pregnancy to subsequent adiposity development, body fat patterning, blood pressure, and blood lipids.

Study Design
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Study Type : Observational
Study Start Date : September 1985
Study Completion Date : March 2000
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005132


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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OverallOfficial: Bruce Barton Maryland Medical Research Institute
OverallOfficial: Paul Canner Maryland Medical Research Institute
OverallOfficial: Stephen Daniels Children's Hospital & Medical Center
OverallOfficial: John Morrison University of Cincinnati
OverallOfficial: Z.I. Sabry University of California at Berkeley
OverallOfficial: George Schreiber Westat, Inc.
More Information
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Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: NGHS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Protocol  This link exits the ClinicalTrials.gov site
Study Forms  This link exits the ClinicalTrials.gov site

Publications:

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ClinicalTrials.gov Identifier: NCT00005132    
Other Study ID Numbers: 1002
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: January 2006
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Vascular Diseases
Myocardial Ischemia