NCT02175108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

June 22, 2014

Last Update Submit

July 13, 2017

Conditions

Cerebral Palsy

Keywords

Cerebral palsyAdolescentsAdultsDietActivityMetabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Calories per day

    Subjects will complete dietary recall and total calories per day will be calculated

    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.

    24 hour

Eligibility Criteria

Age16 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adolescents (16-17) and adults with cerebral palsy

You may qualify if:

  • Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cerebral PalsyMotor ActivityMetabolic Syndrome

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Northwestern University and Attending Physician Shirley Ryan AbilityLab

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 26, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 18, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)