Food AllergyNCT01897506
Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
An observational study of Food Allergy and Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Food Allergy, Asthma, Allergic Rhinitis
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 20 Aug 2018
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Families with children who have allergy appointments at Arkansas Children's Hospital between 1-17 years of age. We will recruit 325 families with patients in the food allergy group and 325 families with patients in the without food allergy group.
Who may be able to join
- Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital between 1-17 years of age with allergic disease
Who cannot join
- Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. Children with immunodeficiency disease will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.
Read the detailed description
Specific Aim 1 To describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy.
Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy.
Specific Aim 3 To examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.
- Keywords
- Food insecurity, Health literacy, Quality of life
- Medical subject headings
- Food Hypersensitivity, Asthma, Rhinitis, Allergic, Dermatitis, Atopic, Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of food insecurity within an atopic population
The primary outcome variable of interest is the presence of food insecurity (patients with Low Food Security or Very Low Food Security). A chi-square test of independence will be used to test the association between food insecurity and food allergy.
Measured: 1.25 years
Secondary outcomes (1)
Health Literacy Rate
A logistic regression analysis will be done to test the effect of food allergy and food insecurity on the health illiteracy rates after adjusting for confounding variables such as demographics. Appropriate contrasts for the interaction effect between food allergy and food insecurity will also be used to compare health literacy rates.
Measured: 1.25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacie M Jones, MD, Principal investigator, University of Arkansas for Medical Sciences / Arkansas Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897506
- Sponsor's protocol ID
- 201920
- Status last verified
- Oct 2018
- First submitted
- 9 Jul 2013
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
- ClinicalTrials.gov ID
- NCT01897506
- Acronym / sponsor ID
- 201920
- Keywords
- Food insecurity, Health literacy, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 12 Jul 2013 (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.
Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.
Detailed description
Specific Aim 1 To describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy.
Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy.
Specific Aim 3 To examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Families with children who have allergy appointments at Arkansas Children's Hospital between 1-17 years of age. We will recruit 325 families with patients in the food allergy group and 325 families with patients in the without food allergy group.
Key inclusion criteria (1 listed)
- Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital between 1-17 years of age with allergic disease
Key exclusion criteria (1 listed)
- Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. Children with immunodeficiency disease will be excluded.
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
Presence of food insecurity within an atopic population
Time frame: 1.25 years
The primary outcome variable of interest is the presence of food insecurity (patients with Low Food Security or Very Low Food Security). A chi-square test of independence will be used to test the association between food insecurity and food allergy.
1 secondary outcome
Health Literacy Rate
Time frame: 1.25 years
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 15 Oct 2018.
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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.
Stacie M Jones, MD principal investigator
University of Arkansas for Medical Sciences / Arkansas Children's Hospital
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 Food Allergy and Asthma, run by Arkansas Children's Hospital Research Institute 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 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 15 Oct 2018. 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?
Presence of food insecurity within an atopic population (time frame: 1.25 years). 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 15 Oct 2018.