- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897506
Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1.25 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Literacy Rate
Time Frame: 1.25 years
|
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.
|
1.25 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life of families with food allergic members
Time Frame: 1.25 years
|
The average quality of life score taken across all six items in the quality of life questionnaire will be the outcome variable of interest.
The mean average quality of life score between the food secure households with food allergy and the food insecure households with food allergy will be compared between the two groups using an ANCOVA method.
|
1.25 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stacie M Jones, MD, University of Arkansas for Medical Sciences / Arkansas Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Esophageal Diseases
- Nose Diseases
- Leukocyte Disorders
- Eosinophilia
- Hypersensitivity
- Dermatitis
- Rhinitis
- Rhinitis, Allergic
- Eosinophilic Esophagitis
- Esophagitis
- Food Hypersensitivity
Other Study ID Numbers
- 201920
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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