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

Adolescent Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031160
• Other study ID #: 999909231
• Secondary ID: 09-CH-N231
• Status: Completed
• Start date: February 17, 2010

Study information

• Verified date: October 24, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4902
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 22 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Adolescent Health

Locations

Country	Name	City	State
United States	National Institute of Child Health and Human Development (NICHD), 9000 Rockville	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

HEALTHY Study Group; Hirst K, Baranowski T, DeBar L, Foster GD, Kaufman F, Kennel P, Linder B, Schneider M, Venditti EM, Yin Z. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S4-20. doi: 10.1038/ijo.2009.112. — View Citation

Pratt C, Webber LS, Baggett CD, Ward D, Pate RR, Murray D, Lohman T, Lytle L, Elder JP. Sedentary activity and body composition of middle school girls: the trial of activity for adolescent girls. Res Q Exerc Sport. 2008 Dec;79(4):458-67. doi: 10.1080/02701367.2008.10599512. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the trajectories of adolescent health and health behaviors, including diet and physical activity, substance use, driving, dating violence, and health status.	Identify the trajectories of adolescent health and health behaviors, including diet and physical activity, substance use, driving, dating violence, and health status.	baseline
Secondary	Identify genetic, individual, family, school, social, and other environmental factors that promote or sustain positive health, positive health behaviors and mental health.	Identify genetic, individual, family, school, social, and other environmental factors that promote or sustain positive health, positive health behaviors and mental health.	ongoing