Health ImpairmentNCT03914573
High School Football and Adult Health
An observational study of Health Impairment and Pain, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The primary aim of the study is to determine the effect of playing high school football on self-rated health in late adulthood. This is an observational study that will use data from the Wisconsin Longitudinal Study, a longitudinal cohort of high school graduates from 1957, to compare graduates who played high school… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Impairment, Pain, Obesity
- How many people
- 3,355 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1957to Dec 2011
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Graduates of Wisconsin high schools in 1957. The data comes from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957.
Who may be able to join
- Male
Who cannot join
- No yearbook information available to determine football playing status
- Sports participation in yearbook was not recorded under senior photo or in an index
- Played a high contact sport other than football (e.g. hockey)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Observational Study of the Association of Participation in High School Football on Health in Late Adulthood
The primary aim of the study is to determine the effect of playing high school football on self-rated health in late adulthood. This is an observational study that will use data from the Wisconsin Longitudinal Study, a longitudinal cohort of high school graduates from 1957, to compare graduates who played high school football with comparable graduates who did not play football on self-rated health, pain, functional ability, and weight at the age of 65 years.
Read the detailed description
Data will be used from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957 to determine the association between participation in high-school football and self-rated health, pain, and obesity in late adulthood. The WLS is an optimal observational dataset to answer these hypotheses. WLS captures early-life exposures that are important predictors of health and well-being in later life such parental socioeconomic status, occupation, and education level, family structure, and race. It also captures whether study participants participated in high school football and contains detailed measurements of their health in adulthood. WLS provides a robust and longitudinal dataset, overcoming the limitations of prior cross-sectional studies, to compare the health in later adulthood of those who played high school football to those who did not, after carefully controlling for a potential confounders
A matched observational study will be conducted, in which football players and controls will be divided into smaller subgroups which are relatively homogeneous along a range of baseline covariates. The outcomes will be compared within each matched set, after adjusting for residual imbalances in the distribution of these baseline covariates between the football players and controls.
- Conditions
- Health Impairment, Pain, Obesity
- Keywords
- health, football, pain, obesity
- Medical subject headings
- Pain, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rated Health
Subjects reported whether their health was excellent, very good, good, fair, or poor. We dichotomized subjects' responses, coding "excellent", "very good", and "good" as 0 and coding "fair" and "poor" as 1
Measured: Collected in 2003-2005 when participants were aged 65
Secondary outcomes (3)
Pain that limits activities
Subjects reported whether during the past 4 weeks, how many of their activities were limited by pain or discomfort. We coded subject responses as 1 if they responded that some, most, or all of their activities were limited and 0 if they responded that none or a few activities were limited.
Measured: Collected in 2003-2005 when participants were aged 65
Difficulty in Activities of Daily Living
Subjects reported whether during the past 4 weeks, have they been able to eat, bathe, dress and use the toilet without difficulty. We coded 0 for no difficulty and 1 for any difficulty.
Measured: Collected in 2003-2005 when participants were aged 65
Maximum Lifetime Body Mass Index
Subjects reported their maximum lifetime weight and the age at which they weighed the most. From these responses, we computed the maximum adult BMI for each subject who reported that they reached their maximum weight when they were 18 years old or older.
Measured: Collected in the WLS mail survey in 2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startJan 1957
- Primary completionDec 2003
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ImpairmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Timothy Gaulton, MD, Principal investigator, University of PennsylvaniaSameer Deshpande, PhD, Principal investigator, Massachusetts Institute of TechnologyDylan Small, PhD, Principal investigator, University of PennsylvaniaMark D Neuman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914573
- Sponsor's protocol ID
- 833020
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Association of Participation in High School Football on Health in Late Adulthood
- ClinicalTrials.gov ID
- NCT03914573
- Acronym / sponsor ID
- 833020
- Conditions
- Health Impairment, Pain, Obesity
- Keywords
- health, football, pain, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,355 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Jan 1957 (actual)
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
The primary aim of the study is to determine the effect of playing high school football on self-rated health in late adulthood. This is an observational study that will use data from the Wisconsin Longitudinal Study, a longitudinal cohort of high school graduates from 1957, to compare graduates who played high school football with comparable graduates who did not play football on self-rated health, pain, functional ability, and weight at the age of 65 years.
Detailed description
Data will be used from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957 to determine the association between participation in high-school football and self-rated health, pain, and obesity in late adulthood. The WLS is an optimal observational dataset to answer these hypotheses. WLS captures early-life exposures that are important predictors of health and well-being in later life such parental socioeconomic status, occupation, and education level, family structure, and race. It also captures whether study participants participated in high school football and contains detailed measurements of their health in adulthood. WLS provides a robust and longitudinal dataset, overcoming the limitations of prior cross-sectional studies, to compare the health in later adulthood of those who played high school football to those who did not, after carefully controlling for a potential confounders
A matched observational study will be conducted, in which football players and controls will be divided into smaller subgroups which are relatively homogeneous along a range of baseline covariates. The outcomes will be compared within each matched set, after adjusting for residual imbalances in the distribution of these baseline covariates between the football players and controls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Graduates of Wisconsin high schools in 1957. The data comes from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957.
Key inclusion criteria (1 listed)
- Male
Key exclusion criteria (3 listed)
- No yearbook information available to determine football playing status
- Sports participation in yearbook was not recorded under senior photo or in an index
- Played a high contact sport other than football (e.g. hockey)
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
Self-rated Health
Time frame: Collected in 2003-2005 when participants were aged 65
Subjects reported whether their health was excellent, very good, good, fair, or poor. We dichotomized subjects' responses, coding "excellent", "very good", and "good" as 0 and coding "fair" and "poor" as 1
3 secondary outcomes
Pain that limits activities
Time frame: Collected in 2003-2005 when participants were aged 65
Difficulty in Activities of Daily Living
Time frame: Collected in 2003-2005 when participants were aged 65
Maximum Lifetime Body Mass Index
Time frame: Collected in the WLS mail survey in 2004
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 18 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Timothy Gaulton, MD principal investigator
University of Pennsylvania
Sameer Deshpande, PhD principal investigator
Massachusetts Institute of Technology
Dylan Small, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Impairment and Pain, run by University of Pennsylvania at 2 sites 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 1 inclusion and 3 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Self-rated Health (time frame: Collected in 2003-2005 when participants were aged 65). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.