Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 11, 2009 | ||||
| Last Updated Date | April 25, 2013 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01031160 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013 | ||||
| Official Title ICMJE | Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2013 | ||||
| Brief Summary | NEXT is a four-year longitudinal assessment of a representative sample of U.S. school children starting at grade 10 The goals of the U.S. NEXT longitudinal study include: to identify the trajectory of adolescent health status and health behaviors from mid-adolescent through the post high school year ;to examine individual predictors o f the on set of key adolescent risk behaviors and risk indicators during this period; to identify family, school, and social / environment factors that promote or sustain positive health behaviors and to identify transition points in health risk and risk behaviors and changes in family, school ,and social / environment precursors to the set transitions. This study will collect reliable and valid data on health behaviors and their social and environmental contexts from students in a four-year longitudinal, nationally-representative Probability sample of l0th-grade children in the U.S. Measures will be collected annually for four years beginning in the 2009-2010 school year. Hispanic and African - American youth will be over sampled to provide better population estimates of these groups and to provide an adequate sample to examine racial/ ethnic differences in longitudinal predictors o f health, health behaviors and health behavior change. Self-reports of health status health behaviors and health attitudes will be collected by in-school and online surveys. Anthropometic data, genetic information, and neighborhood characteristics will be gathered on all participants as well. The study will also incorporate an Administrator Survey and other data files to obtain related information on school-level health programs and community-level on textual data to support NICHD and the Maternal and Child Health Branch of the Health Resources and Services Administration ( HRSA/NICHB) in program requirements that address supportive health environments for adolescents. In. addition, a representative sub sample of overweight and normal weight adolescents will be identified: additional data on behavioral risk factors and biological markers and risk factors will be gathered on these adolescents. |
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| Detailed Description | NEXT is a four-year longitudinal assessment of a representative sample of U.S. school children starting at grade 10 The goals of the U.S. NEXT longitudinal study include: to identify the trajectory of adolescent health status and health behaviors from mid-adolescent through the post high school year ;to examine individual predictors o f the on set of key adolescent risk behaviors and risk indicators during this period; to identify family, school, and social / environment factors that promote or sustain positive health behaviors and to identify transition points in health risk and risk behaviors and changes in family, school ,and social / environment precursors to the set transitions. This study will collect reliable and valid data on health behaviors and their social and environmental contexts from students in a four-year longitudinal, nationally-representative probability sample of l0th-grade children in the U.S. Measures will be collected annually for four years beginning in the 2009-2010 school year. African - American youth will be over sampled to provide better population estimates of these groups and to provide an adequate sample to examine racial/ ethnic differences in longitudinal predictors o f health, health behaviors and health behavior change. Hispanic yout will not require oversampling because they currently represent a sufficient proportion of the population of adolescents to provide an adequate sample to examine racial/ethnic differences. Self-reports of health status health behaviors and health attitudes will be collected by in-school and online surveys. Anthropometic data, genetic information, and neighborhood characteristics will be gathered on all participants as well. The study will also incorporate an Administrator Survey and other data files to obtain related information on school-level health programs and community-level on textual data to support NICHD and the Maternal and Child Health Branch of the Health Resources and Services Administration ( HRSA/NICHB) in program requirements that address supportive health environments for adolescents. In addition, a representative sub sample of overweight and normal weight adolescents will be identified: additional data on behavioral risk factors and biological markers and risk factors will be gathered on these adolescents. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 9400 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE |
Survey Inclusion Criteria -Students are included in the survey if they are attending 10th grade in public or private schools in the U.S., can read and understand English, and they and their parents have completed informed consent/assent to participate in the study. Home Visit Inclusion Criteria -Children are included in the home visit if they have met the criteria for and have completed the in-school survey and the in-school assessments of height and weight and they and their parents have completed the in-home study consent and assent forms. EXCLUSION CRITERIA: Survey Exclusion Criteria Children are excluded from participating in the survey for any of the following:
Home Visit Exclusion Criteria
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| Gender | Both | ||||
| Ages | 13 Years to 22 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01031160 | ||||
| Other Study ID Numbers ICMJE | 999909231, 09-CH-N231 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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