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National Growth and Health Study (NGHS)

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

No eligibility criteria

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Stephen Daniels, Children's Hospital & Medical Center
  • George Schreiber, Westat, Inc.
  • Bruce Barton, Maryland Medical Research Institute
  • Paul Canner, Maryland Medical Research Institute
  • John Morrison, University of Cincinnati
  • Z.I. Sabry, University of California at Berkeley

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 1985

Studieafslutning

1. marts 2000

Datoer for studieregistrering

Først indsendt

25. maj 2000

Først indsendt, der opfyldte QC-kriterier

25. maj 2000

Først opslået (Skøn)

26. maj 2000

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. april 2016

Sidst verificeret

1. januar 2006

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1002

Plan for individuelle deltagerdata (IPD)

Studiedata/dokumenter

  1. Individuelt deltagerdatasæt
    Informations-id: NGHS
    Oplysningskommentarer: 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.
  2. Studieprotokol
  3. Studieformularer

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjertesygdomme

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