Assessing Risk of Food Insecurity Within Households of Children With Food Allergy

Asthma Clinical Trial

Official title:

Assessing Risk of Food Insecurity Within Households of Children With Food Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897506
• Other study ID #: 201920
• Status: Completed
• Start date: June 2013
• Est. completion date: August 20, 2018

Study information

• Verified date: October 2018
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: August 20, 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eosinophilic Esophagitis
• Esophagitis
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life of families with food allergic members	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
Primary	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.	1.25 years
Secondary	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.	1.25 years