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

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.

Study Overview

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

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

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

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

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

  • 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stacie M Jones, MD, University of Arkansas for Medical Sciences / Arkansas Children's Hospital

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

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

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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