Cardiovascular DiseasesNCT00005132
National Growth and Health Study (NGHS)
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 19 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1985to Mar 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Coronary Disease, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity, Coronary Disease, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1985
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Bruce Barton, Maryland Medical Research InstitutePaul Canner, Maryland Medical Research InstituteStephen Daniels, Children's Hospital & Medical CenterJohn Morrison, University of CincinnatiZ.I. Sabry, University of California at BerkeleyGeorge Schreiber, Westat, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005132
- Sponsor's protocol ID
- 1002
- Status last verified
- Jan 2006
- First submitted
- 25 May 2000
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
Schumann BC, Striegel-Moore RH, McMahon RP, Waclawiw MA, Morrison JA, Schreiber GB. Psychometric properties of the Self-Perception Profile for Children in a biracial cohort of adolescent girls: the NHLBI Growth and Health Study. J Pers Assess. 1999 Oct;73(2):260-75. doi: 10.1207/S15327752JPA7302_5.
PubMed 10624004Morrison JA, Sprecher DL, Barton BA, Waclawiw MA, Daniels SR. Overweight, fat patterning, and cardiovascular disease risk factors in black and white girls: The National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 1999 Oct;135(4):458-64. doi: 10.1016/s0022-3476(99)70168-x.
PubMed 10518079Kimm SY, Pasagian-Macaulay A, Aston CE, McAllister AE, Glynn NW, Kamboh MI, Ferrell RE. Correlates of lipoprotein(a) levels in a biracial cohort of young girls: the NHLBI Growth and Health Study. J Pediatr. 1999 Aug;135(2 Pt 1):169-76. doi: 10.1016/s0022-3476(99)70018-1.
PubMed 10431110Striegel-Moore RH, Morrison JA, Schreiber G, Schumann BC, Crawford PB, Obarzanek E. Emotion-induced eating and sucrose intake in children: the NHLBI Growth and Health Study. Int J Eat Disord. 1999 May;25(4):389-98. doi: 10.1002/(sici)1098-108x(199905)25:43.0.co;2-4.
PubMed 10202649Patterson ML, Stern S, Crawford PB, McMahon RP, Similo SL, Schreiber GB, Morrison JA, Waclawiw MA. Sociodemographic factors and obesity in preadolescent black and white girls: NHLBI's Growth and Health Study. J Natl Med Assoc. 1997 Sep;89(9):594-600.
PubMed 9302856Sprecher DL, Morrison JA, Simbartl LA, Schreiber GB, Sabry ZI, Biro FM, Barton BA. Lipoprotein and apolipoprotein differences in black and white girls. The National Heart, Lung, and Blood Institute Growth and Health Study. Arch Pediatr Adolesc Med. 1997 Jan;151(1):84-90. doi: 10.1001/archpedi.1997.02170380088014.
PubMed 9006534Daniels SR, Obarzanek E, Barton BA, Kimm SY, Similo SL, Morrison JA. Sexual maturation and racial differences in blood pressure in girls: the National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 1996 Aug;129(2):208-13. doi: 10.1016/s0022-3476(96)70244-5.
PubMed 8765617Kimm SY, Obarzanek E, Barton BA, Aston CE, Similo SL, Morrison JA, Sabry ZI, Schreiber GB, McMahon RP. Race, socioeconomic status, and obesity in 9- to 10-year-old girls: the NHLBI Growth and Health Study. Ann Epidemiol. 1996 Jul;6(4):266-75. doi: 10.1016/s1047-2797(96)00056-7.
PubMed 8876836Schreiber GB, Robins M, Striegel-Moore R, Obarzanek E, Morrison JA, Wright DJ. Weight modification efforts reported by black and white preadolescent girls: National Heart, Lung, and Blood Institute Growth and Health Study. Pediatrics. 1996 Jul;98(1):63-70.
PubMed 8668414Morrison JA, Sprecher D, McMahon RP, Simon J, Schreiber GB, Khoury PR. Obesity and high-density lipoprotein cholesterol in black and white 9- and 10-year-old girls: The National Heart, Lung, and Blood Institute Growth and Health Study. Metabolism. 1996 Apr;45(4):469-74. doi: 10.1016/s0026-0495(96)90221-8.
PubMed 8609833Biro FM, Daniels SR, Similo SL, Barton BA, Payne GH, Morrison JA. Differential classification of blood pressure by fourth and fifth Korotkoff phases in school-aged girls. The National Heart, Lung, and Blood Institute Growth and Health Study. Am J Hypertens. 1996 Mar;9(3):242-7. doi: 10.1016/0895-7061(95)00295-2.
PubMed 8695023Crawford PB, Obarzanek E, Schreiber GB, Barrier P, Goldman S, Frederick MM, Sabry ZI. The effects of race, household income, and parental education on nutrient intakes of 9- and 10-year-old girls. NHLBI Growth and Health Study. Ann Epidemiol. 1995 Sep;5(5):360-8. doi: 10.1016/1047-2797(95)00033-4.
PubMed 8653208Obarzanek E, Schreiber GB, Crawford PB, Goldman SR, Barrier PM, Frederick MM, Lakatos E. Energy intake and physical activity in relation to indexes of body fat: the National Heart, Lung, and Blood Institute Growth and Health Study. Am J Clin Nutr. 1994 Jul;60(1):15-22. doi: 10.1093/ajcn/60.1.15.
PubMed 8017331Morrison JA, Barton B, Biro FM, Sprecher DL, Falkner F, Obarzanek E. Sexual maturation and obesity in 9- and 10-year-old black and white girls: the National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 1994 Jun;124(6):889-95. doi: 10.1016/s0022-3476(05)83176-2.
PubMed 8201472Crawford PB, Obarzanek E, Morrison J, Sabry ZI. Comparative advantage of 3-day food records over 24-hour recall and 5-day food frequency validated by observation of 9- and 10-year-old girls. J Am Diet Assoc. 1994 Jun;94(6):626-30. doi: 10.1016/0002-8223(94)90158-9.
PubMed 8195550
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Growth and Health Study (NGHS)
- ClinicalTrials.gov ID
- NCT00005132
- Acronym / sponsor ID
- 1002
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Coronary Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1985
- Study completion
- Mar 2000
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Who may qualify
- Ages
- 9 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 10624004Schumann BC, Striegel-Moore RH, McMahon RP, Waclawiw MA, Morrison JA, Schreiber GB. Psychometric properties of the Self-Perception Profile for Children in a biracial cohort of adolescent girls: the NHLBI Growth and Health Study. J Pers Assess. 1999 Oct;73(2):260-75. doi: 10.1207/S15327752JPA7302_5.
- Background: PubMed 10518079Morrison JA, Sprecher DL, Barton BA, Waclawiw MA, Daniels SR. Overweight, fat patterning, and cardiovascular disease risk factors in black and white girls: The National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 1999 Oct;135(4):458-64. doi: 10.1016/s0022-3476(99)70168-x.
- Background: PubMed 10431110Kimm SY, Pasagian-Macaulay A, Aston CE, McAllister AE, Glynn NW, Kamboh MI, Ferrell RE. Correlates of lipoprotein(a) levels in a biracial cohort of young girls: the NHLBI Growth and Health Study. J Pediatr. 1999 Aug;135(2 Pt 1):169-76. doi: 10.1016/s0022-3476(99)70018-1.
- Background: PubMed 10202649Striegel-Moore RH, Morrison JA, Schreiber G, Schumann BC, Crawford PB, Obarzanek E. Emotion-induced eating and sucrose intake in children: the NHLBI Growth and Health Study. Int J Eat Disord. 1999 May;25(4):389-98. doi: 10.1002/(sici)1098-108x(199905)25:43.0.co;2-4.
- Background: PubMed 9302856Patterson ML, Stern S, Crawford PB, McMahon RP, Similo SL, Schreiber GB, Morrison JA, Waclawiw MA. Sociodemographic factors and obesity in preadolescent black and white girls: NHLBI's Growth and Health Study. J Natl Med Assoc. 1997 Sep;89(9):594-600.
- Background: PubMed 9006534Sprecher DL, Morrison JA, Simbartl LA, Schreiber GB, Sabry ZI, Biro FM, Barton BA. Lipoprotein and apolipoprotein differences in black and white girls. The National Heart, Lung, and Blood Institute Growth and Health Study. Arch Pediatr Adolesc Med. 1997 Jan;151(1):84-90. doi: 10.1001/archpedi.1997.02170380088014.
- Background: PubMed 8765617Daniels SR, Obarzanek E, Barton BA, Kimm SY, Similo SL, Morrison JA. Sexual maturation and racial differences in blood pressure in girls: the National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 1996 Aug;129(2):208-13. doi: 10.1016/s0022-3476(96)70244-5.
- Background: PubMed 8876836Kimm SY, Obarzanek E, Barton BA, Aston CE, Similo SL, Morrison JA, Sabry ZI, Schreiber GB, McMahon RP. Race, socioeconomic status, and obesity in 9- to 10-year-old girls: the NHLBI Growth and Health Study. Ann Epidemiol. 1996 Jul;6(4):266-75. doi: 10.1016/s1047-2797(96)00056-7.
- Background: PubMed 8668414Schreiber GB, Robins M, Striegel-Moore R, Obarzanek E, Morrison JA, Wright DJ. Weight modification efforts reported by black and white preadolescent girls: National Heart, Lung, and Blood Institute Growth and Health Study. Pediatrics. 1996 Jul;98(1):63-70.
- Background: PubMed 8609833Morrison JA, Sprecher D, McMahon RP, Simon J, Schreiber GB, Khoury PR. Obesity and high-density lipoprotein cholesterol in black and white 9- and 10-year-old girls: The National Heart, Lung, and Blood Institute Growth and Health Study. Metabolism. 1996 Apr;45(4):469-74. doi: 10.1016/s0026-0495(96)90221-8.
- Background: PubMed 8695023Biro FM, Daniels SR, Similo SL, Barton BA, Payne GH, Morrison JA. Differential classification of blood pressure by fourth and fifth Korotkoff phases in school-aged girls. The National Heart, Lung, and Blood Institute Growth and Health Study. Am J Hypertens. 1996 Mar;9(3):242-7. doi: 10.1016/0895-7061(95)00295-2.
- Background: PubMed 8653208Crawford PB, Obarzanek E, Schreiber GB, Barrier P, Goldman S, Frederick MM, Sabry ZI. The effects of race, household income, and parental education on nutrient intakes of 9- and 10-year-old girls. NHLBI Growth and Health Study. Ann Epidemiol. 1995 Sep;5(5):360-8. doi: 10.1016/1047-2797(95)00033-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Barton
Maryland Medical Research Institute
Paul Canner
Maryland Medical Research Institute
Stephen Daniels
Children's Hospital & Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005132, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.