Cystic FibrosisFINCT03318328
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Dixie Durham.
Trial summary
A survey of adults and parents of children with cystic fibrosis on food insecurity Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- survey
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Mar 2015
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adults and parents of children with cystic fibrosis
Who may be able to join
None listed.
Who cannot join
- NA
About this study
A survey of adults and parents of children with cystic fibrosis on food insecurity
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- survey
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate food insecurity incidence in CF patients
Using a survey, determine the number of people who report food insecurity
Measured: one time questionnaire administered during a clinic visit
Secondary outcomes (2)
Determine if food insecurity leads to worse lung function in CF patients
Using a survey, report the current FEV1 and the number of people who report food insecurity to determine if there is a correlation
Measured: one time questionnaire administered during a clinic visit
Determine if food insecurity leads to worse BMI in CF patients
using a survey, report the current BMI and the number of people who report food insecurity to see if there is a correlation
Measured: one time questionnaire administered during a clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Aug 2013
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dixie Durham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dixie Durham, St. Luke's Health System, Boise, Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318328
- Sponsor's protocol ID
- 2017Food
- Acronym
- FI
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2017
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03318328
- Acronym / sponsor ID
- FI / 2017Food
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Dixie DurhamUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 23 Oct 2017 (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.
A survey of adults and parents of children with cystic fibrosis on food insecurity
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adults and parents of children with cystic fibrosis
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey | Other | – |
Primary outcome
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
2 secondary outcomes
Determine if food insecurity leads to worse lung function in CF patients
Time frame: 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.
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 30 Nov 2023.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Dixie Durham.
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 0 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate food insecurity incidence in CF patients (time frame: one time questionnaire administered during a clinic visit). 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 30 Nov 2023.