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Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2016

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ClinicalTrials.gov Identifier: NCT01031160
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Tracking Information
First Submitted Date December 11, 2009
First Posted Date December 14, 2009
Last Update Posted Date March 22, 2021
Actual Study Start Date February 17, 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: February 6, 2019)
Identify the trajectories of adolescent health and health behaviors, including diet and physical activity, substance use, driving, dating violence, and health status. [ Time Frame: baseline ]
Identify the trajectories of adolescent health and health behaviors, including diet and physical activity, substance use, driving, dating violence, and health status.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 6, 2019)
Identify genetic, individual, family, school, social, and other environmental factors that promote or sustain positive health, positive health behaviors and mental health. [ Time Frame: ongoing ]
Identify genetic, individual, family, school, social, and other environmental factors that promote or sustain positive health, positive health behaviors and mental health.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2016
Official Title Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2016
Brief Summary

NEXT is a seven-year longitudinal assessment of a representative sample of U.S. adolescent and young adults starting at grade 10. The goals of the NEXT longitudinal study include: to identify the trajectory of adolescent health status and health behaviors from mid-adolescence through the post high school years; to examine individual predictors of the onset of key adolescent risk behaviors and risk indicators during this period; to identify genetic, personal, family, school, and social/environmental factors that promote or sustain positive health behaviors; to identify transition points in health risk and risk behaviors and changes in family, school, and social/environmental precursors to these transitions, and to examine the role of potential gene-environment interactions in the development of health status and health behaviors. .

This study collects reliable and valid data on health behaviors and health indicators and their social, environmental, and biological contexts beginning with a nationally representative probability cohort of 10th-grade children in the U.S in 2009 and following them through 2016. Measures are collected annually for seven years beginning in the 2009-2010 school year and ending in the 2016-2017 school year. African-American youth are oversampled to provide better population estimates of this group and to provide an adequate sample to examine racial/ethnic differences in longitudinal predictors of health, health behaviors, and health behavior change. Hispanic youth do 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 are collected by in-school and online surveys. Anthropometric data, genetic information, and neighborhood characteristics are gathered on all participants as well. The study also incorporates an Administrator Survey and other data sources to obtain related information on school-level health programs and community-level contextual data. The NEXT Generation Health Study data support NICHD, National Heart, Lung and Blood Institute (NHLBI), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Maternal and Child Health Branch of the Health Resources and Services Administration (HRSA/MCHB) in fulfillment of program requirements that address supportive health environments for adolescents and young adults. In addition, a representative subsample of overweight and normal weight adolescents has been identified: additional data on behavioral risk factors and biological markers and risk factors are gathered on these adolescents. Driving performance will also be evaluated in 150 young adults.

Detailed Description

NEXT is a seven-year longitudinal assessment of a representative sample of U.S. adolescent and young adults starting at grade 10. The goals of the NEXT longitudinal study include: to identify the trajectory of adolescent health status and health behaviors from mid-adolescence through the post high school years; to examine individual predictors of the onset of key adolescent risk behaviors and risk indicators during this period; to identify genetic, personal, family, school, and social/environmental factors that promote or sustain positive health behaviors; to identify transition points in health risk and risk behaviors and changes in family, school, and social/environmental precursors to these transitions, and to examine the role of potential gene-environment interactions in the development of health status and health behaviors. .

This study collects reliable and valid data on health behaviors and health indicators and their social, environmental, and biological contexts beginning with a nationally representative probability cohort of 10th-grade children in the U.S in 2009 and following them through 2016. Measures are collected annually for seven years beginning in the 2009-2010 school year and ending in the 2016-2017 school year. African-American youth are oversampled to provide better population estimates of this group and to provide an adequate sample to examine racial/ethnic differences in longitudinal predictors of health, health behaviors, and health behavior change. Hispanic youth do 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 are collected by in-school and online surveys. Anthropometric data, genetic information, and neighborhood characteristics are gathered on all participants as well. The study also incorporates an Administrator Survey and other data sources to obtain related information on school-level health programs and community-level contextual data. The NEXT Generation Health Study data support NICHD, National Heart, Lung and Blood Institute (NHLBI), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Maternal and Child Health Branch of the Health Resources and Services Administration (HRSA/MCHB) in fulfillment of program requirements that address supportive health environments for adolescents and young adults. In addition, a representative subsample of overweight and normal weight adolescents has been identified: additional data on behavioral risk factors and biological markers and risk factors are gathered on these adolescents. Driving performance will also be evaluated in 150 young adults.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study will include two phases. Phase 1 will include a secondary data analysis with emerging adults and peer driving data acquired from the NEXT Longitudinal Study collected by the National Institute of Child Health and Human Development (NICHD) at the NIH. Phase 2 will include conducting qualitative data collection through 4-5 focus groups on University of Maryland College Park (UMCP) campus with undergraduate students (age 18-22) to understand the influential factors associated with social norms on distracted driving
Condition Adolescent Health
Intervention Not Provided
Study Groups/Cohorts U.S. high school students
U.S. high school students who were in 10th grade in the 2009-2010 school year.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
4902
Original Estimated Enrollment
 (submitted: December 11, 2009)
2700
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

Both boys and girls will be recruited for participation in the study. African American youth will be over-sampled to improve population estimates

Study Inclusion Criteria:

All participants previously recruited in the NEXT Generation Health Study are eligible for inclusion in the future assessments.

Next Plus Inclusion Criteria:

Participants are included in the NEXT Plus if they met the criteria for and completed the NEXT survey in Wave 1 and the Wave 1 in-school assessments of height and weight and they and their parents completed the NEXT Plus consent and assent forms.

EXCLUSION CRITERIA:

Survey Exclusion Criteria:

Participants are excluded from participating in the study for any of the following:

  • No informed consent from parent(s),
  • No informed assent/consent (depending on age) from the participant, or
  • Developmental limitations that affect the participant s ability to understand or provide age appropriate responses to the questions posed

Home Visit Exclusion Criteria:

Participants are excluded from participating in NEXT Plus for any of the following:

  • No informed consent from parent(s),
  • No informed assent/consent from the child,
  • Developmental limitations that affect the child s ability to understand or provide age appropriate responses to the questions posed, or
  • A blood condition that increases the risk of bleeding.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01031160
Other Study ID Numbers 999909231
09-CH-N231
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Denise L Haynie, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 15, 2020