Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005132
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2000-05-25
Brief Title:
National Growth and Health Study NGHS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 andor 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
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 andor 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 andor 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: