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National Growth and Health Study (NGHS)

13 de abril de 2016 actualizado por: National Heart, Lung, and Blood Institute (NHLBI)
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.

Descripción general del estudio

Descripción detallada

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 de estudio

De observación

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

9 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

No eligibility criteria

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • 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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 1985

Finalización del estudio

1 de marzo de 2000

Fechas de registro del estudio

Enviado por primera vez

25 de mayo de 2000

Primero enviado que cumplió con los criterios de control de calidad

25 de mayo de 2000

Publicado por primera vez (Estimar)

26 de mayo de 2000

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de abril de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

13 de abril de 2016

Última verificación

1 de enero de 2006

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1002

Plan de datos de participantes individuales (IPD)

Datos del estudio/Documentos

  1. Conjunto de datos de participantes individuales
    Identificador de información: NGHS
    Comentarios de información: 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. Protocolo de estudio
  3. Formularios de estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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