- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318328
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis (FI)
November 27, 2023 updated by: Dixie Durham
A survey of adults and parents of children with cystic fibrosis on food insecurity
Study Overview
Detailed Description
A survey of adults and parents of children with cystic fibrosis to determine any correlation between food insecurity and BMI or food insecurity and FEV1, and to determine what level of food insecurity is present.
Study Type
Observational
Enrollment (Actual)
87
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
adults and parents of children with cystic fibrosis
Description
Inclusion Criteria: have CF and are willing to complete a questionnaire during a routine clinic visit
-
Exclusion Criteria:
- NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate food insecurity incidence in CF patients
Time Frame: one time questionnaire administered during a clinic visit
|
Using a survey, determine the number of people who report food insecurity
|
one time questionnaire administered during a clinic visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine if food insecurity leads to worse lung function in CF patients
Time Frame: one time questionnaire administered during a clinic visit
|
Using a survey, report the current FEV1 and the number of people who report food insecurity to determine if there is a correlation
|
one time questionnaire administered during a clinic visit
|
Determine if food insecurity leads to worse BMI in CF patients
Time Frame: one time questionnaire administered during a clinic visit.
|
using a survey, report the current BMI and the number of people who report food insecurity to see if there is a correlation
|
one time questionnaire administered during a clinic visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2013
Primary Completion (Actual)
March 31, 2015
Study Completion (Actual)
March 31, 2015
Study Registration Dates
First Submitted
October 16, 2017
First Submitted That Met QC Criteria
October 18, 2017
First Posted (Actual)
October 23, 2017
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017Food
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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