Diet and Activity in Cerebral Palsy | NCT02175108

Studies
Diet and Activity in Cerebral Palsy

NCT02175108

Sponsor

Shirley Ryan AbilityLab

Status

Completed

Last Update Posted

Jul 18, 2017Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jun 22, 2014

First Submission Date that Met QC Criteria

Jun 25, 2014

First Posted Date

Jun 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2017

Last Update Posted Date

Jul 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christina Marciniak, Professor, Northwestern University and Attending Physician Shirley Ryan AbilityLab, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Shirley Ryan AbilityLabOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

89 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Adolescents (16-17) and adults with cerebral palsy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shirley Ryan AbilityLab		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D009043	Motor Activity
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided