Adolescent HealthNCT01031160
Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2016
An observational study of Adolescent Health, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Adolescent Health
- How many people
- 4,902 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Adolescent Health
- Keywords
- Health Indicators, Health Behaviors, Health Study, Natural History, Substance Abuse, Adolescence, Obesity
- Medical subject headings
- Health Behavior, Substance-Related Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| U.S. high school students | U.S. high school students who were in 10th grade in the 2009-2010 school year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start17 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adolescent HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Leah M Lipsky, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031160
- Sponsor's protocol ID
- 999909231
- Other IDs
- 09-CH-N231
- Status last verified
- 20 Jul 2026
- First submitted
- 11 Dec 2009
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol does not indicate plans on IPD availability.
Publications
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.
PubMed 19177947HEALTHY 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.
PubMed 19623188Yu J, Goldstein RB, Haynie DL, Luk JW, Fairman BJ, Patel RA, Vidal-Ribas P, Maultsby K, Gudal M, Gilman SE. Resilience Factors in the Association Between Depressive Symptoms and Suicidality. J Adolesc Health. 2021 Aug;69(2):280-287. doi: 10.1016/j.jadohealth.2020.12.004. Epub 2021 Jan 9.
PubMed 33431248Luk JW, Sita KR, Lewin D, Simons-Morton BG, Haynie DL. Sexual Orientation and Sleep Behaviors in a National Sample of Adolescents Followed Into Young Adulthood. J Clin Sleep Med. 2019 Nov 15;15(11):1635-1643. doi: 10.5664/jcsm.8030.
PubMed 31739854Haynie DL, Lewin D, Luk JW, Lipsky LM, O'Brien F, Iannotti RJ, Liu D, Simons-Morton BG. Beyond Sleep Duration: Bidirectional Associations Among Chronotype, Social Jetlag, and Drinking Behaviors in a Longitudinal Sample of US High School Students. Sleep. 2018 Feb 1;41(2):zsx202. doi: 10.1093/sleep/zsx202.
PubMed 29237053Lipsky LM, Nansel TR, Haynie DL, Liu D, Li K, Pratt CA, Iannotti RJ, Dempster KW, Simons-Morton B. Diet quality of US adolescents during the transition to adulthood: changes and predictors. Am J Clin Nutr. 2017 Jun;105(6):1424-1432. doi: 10.3945/ajcn.116.150029. Epub 2017 Apr 26.
PubMed 28446498
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior in School-Age Children: NEXT Longitudinal Study 2009-2016
- ClinicalTrials.gov ID
- NCT01031160
- Acronym / sponsor ID
- 999909231
- Conditions
- Adolescent Health
- Keywords
- Health Indicators, Health Behaviors, Health Study, Natural History, Substance Abuse, Adolescence, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,902 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 17 Feb 2010 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. high school students | – | –U.S. high school students who were in 10th grade in the 2009-2010 school year. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- Both boys and girls will be recruited for participation in the study. African American youth will be over-sampled to improve population estimates
- All participants previously recruited in the NEXT Generation Health Study are eligible for inclusion in the future assessments.
- 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.
Key exclusion criteria (11 listed)
- 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
- No informed consent from parent(s),
- No informed assent/consent from the child,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 19177947Pratt 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.
- Background: PubMed 19623188HEALTHY 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.
- Derived from this study: PubMed 33431248Yu J, Goldstein RB, Haynie DL, Luk JW, Fairman BJ, Patel RA, Vidal-Ribas P, Maultsby K, Gudal M, Gilman SE. Resilience Factors in the Association Between Depressive Symptoms and Suicidality. J Adolesc Health. 2021 Aug;69(2):280-287. doi: 10.1016/j.jadohealth.2020.12.004. Epub 2021 Jan 9.
- Derived from this study: PubMed 31739854Luk JW, Sita KR, Lewin D, Simons-Morton BG, Haynie DL. Sexual Orientation and Sleep Behaviors in a National Sample of Adolescents Followed Into Young Adulthood. J Clin Sleep Med. 2019 Nov 15;15(11):1635-1643. doi: 10.5664/jcsm.8030.
- Derived from this study: PubMed 29237053Haynie DL, Lewin D, Luk JW, Lipsky LM, O'Brien F, Iannotti RJ, Liu D, Simons-Morton BG. Beyond Sleep Duration: Bidirectional Associations Among Chronotype, Social Jetlag, and Drinking Behaviors in a Longitudinal Sample of US High School Students. Sleep. 2018 Feb 1;41(2):zsx202. doi: 10.1093/sleep/zsx202.
- Derived from this study: PubMed 28446498Lipsky LM, Nansel TR, Haynie DL, Liu D, Li K, Pratt CA, Iannotti RJ, Dempster KW, Simons-Morton B. Diet quality of US adolescents during the transition to adulthood: changes and predictors. Am J Clin Nutr. 2017 Jun;105(6):1424-1432. doi: 10.3945/ajcn.116.150029. Epub 2017 Apr 26.
- Individual participant dataSharing planned: No. Protocol does not indicate plans on IPD availability.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah M Lipsky principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Health, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031160, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.