Cerebral PalsyNCT02175108
Diet and Activity in Cerebral Palsy
An observational study of Cerebral Palsy, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population. Read more about this study
- Who is it for?
- Ages 16 to 89 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2017
- 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 16 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescents (16-17) and adults with cerebral palsy
Who may be able to join
- Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy
Who cannot join
- Concurrent severe neurologic or other medical diagnosis that is likely to be contributing to the subject's functional impairment, as determined by the study investigators. For example, associated spinal cord injury.
- Subjects with major limb amputations
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIET, ACTIVITY AND MEDICAL CO-MORBIDITIES IN ADOLESCENTS and ADULTS WITH CEREBRAL PALSY: WHAT ARE THE EFFECTS ON THE METABOLIC PROFILE?
This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Adolescents, Adults, Diet, Activity, Metabolic Syndrome
- Medical subject headings
- Cerebral Palsy, Motor Activity, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories per day
Subjects will complete dietary recall and total calories per day will be calculated
Measured: 24 hour dietary recall
Total saturated fats per day
24 hour dietary recall will be performed, and total saturated fats ingested over 24 hours will be calculated.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Marciniak, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175108
- Sponsor's protocol ID
- STU00093759
- Status last verified
- Oct 2016
- First submitted
- 22 Jun 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIET, ACTIVITY AND MEDICAL CO-MORBIDITIES IN ADOLESCENTS and ADULTS WITH CEREBRAL PALSY: WHAT ARE THE EFFECTS ON THE METABOLIC PROFILE?
- ClinicalTrials.gov ID
- NCT02175108
- Acronym / sponsor ID
- STU00093759
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Adolescents, Adults, Diet, Activity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Jun 2014 (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.
This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents (16-17) and adults with cerebral palsy
Key inclusion criteria (1 listed)
- Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy
Key exclusion criteria (3 listed)
- Concurrent severe neurologic or other medical diagnosis that is likely to be contributing to the subject's functional impairment, as determined by the study investigators. For example, associated spinal cord injury.
- Subjects with major limb amputations
- Pregnant or lactating females
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
Calories per day
Time frame: 24 hour dietary recall
Subjects will complete dietary recall and total calories per day will be calculated
Total saturated fats per day
Time frame: 24 hour
24 hour dietary recall will be performed, and total saturated fats ingested over 24 hours will be calculated.
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 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cerebral Palsy, run by Shirley Ryan AbilityLab 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 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 Jul 2017. 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?
Calories per day (time frame: 24 hour dietary recall). The study lists 2 primary outcomes in all. 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 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.