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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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 9 anni a 19 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

No eligibility criteria

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • 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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 1985

Completamento dello studio

1 marzo 2000

Date di iscrizione allo studio

Primo inviato

25 maggio 2000

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2000

Primo Inserito (Stima)

26 maggio 2000

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 aprile 2016

Ultimo verificato

1 gennaio 2006

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1002

Piano per i dati dei singoli partecipanti (IPD)

Dati/documenti di studio

  1. Set di dati del singolo partecipante
    Identificatore informazioni: NGHS
    Commenti informativi: 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. Protocollo di studio
  3. Moduli di studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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