Ignite Creation Date:
2024-05-06 @ 12:25 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01571830
Status:
COMPLETED
Last Update Posted:
2015-08-06
First Post:
2012-04-03
Brief Title:
Improving Nutrient Intake and Growth in Children With Multiple Food Allergies
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Improving Nutrient Intake and Growth in Children With Multiple Food Allergies
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis 1 Food allergies are associated with poor growth which can be corrected with nutrition intervention
More than 10 of children with multiple food allergies will have a weight-for-age z-score less than - 2 at diagnosis The z-score is a measure of the distance from the mean value or 50th percentile on the growth chart A z-score of less than - 2 indicates that the child is underweight
Growth parameters of children with multiple food allergies will improve after intervention by a team that includes a dietitian and an allergist
Hypothesis 2 Food allergies are associated with low micronutrient intake which can be corrected with nutrition intervention
o More than 30 of children with multiple food allergies will consume less than 67 of the Dietary Reference Intake for at least one macronutrient or micronutrient at diagnosis
Macronutrient and micronutrient intake will increase after intervention by a team that includes a dietitian and an allergist
o
Hypothesis 3 Food allergies are related to behavioral feeding problems which can be corrected with nutrition intervention
At least 25 of children with multiple food allergies will have behavioral feeding problems at diagnosis
Prevalence of behavioral feeding problems will decrease after nutrition intervention
More than 10 of children with multiple food allergies will have a weight-for-age z-score less than - 2 at diagnosis The z-score is a measure of the distance from the mean value or 50th percentile on the growth chart A z-score of less than - 2 indicates that the child is underweight
Growth parameters of children with multiple food allergies will improve after intervention by a team that includes a dietitian and an allergist
Hypothesis 2 Food allergies are associated with low micronutrient intake which can be corrected with nutrition intervention
o More than 30 of children with multiple food allergies will consume less than 67 of the Dietary Reference Intake for at least one macronutrient or micronutrient at diagnosis
Macronutrient and micronutrient intake will increase after intervention by a team that includes a dietitian and an allergist
o
Hypothesis 3 Food allergies are related to behavioral feeding problems which can be corrected with nutrition intervention
At least 25 of children with multiple food allergies will have behavioral feeding problems at diagnosis
Prevalence of behavioral feeding problems will decrease after nutrition intervention
Detailed Description:
This is a prospective observational study with repeated measure design All participants aged 6 months to 6 years diagnosed with two or more food allergies will be invited to participate in the research study At least one of the two food allergies must be milk egg wheat or soy which are nutritionally important food allergies Inclusion criteria include diagnosis of two or more food allergies confirmed with skin prick testing or serum specific IgE SIgEtesting Participants aged 12 months or older will be invited to participate in the Mealtime Behavior Questionnaire MBQ and Feeding Strategies Questionnaire FSQ Participants with developmental delay genetic syndromes or other chronic medical conditions will be excluded from the study Participants with two or more food allergies that do not have at least one nutritionally important food allergy milk egg wheat soy will not be invited to participate in the study We will also exclude participants with a history of digestive surgery non English-speaking patients and patients currently receiving nutrition support enteral or parenteral nutrition Patients will be excluded if they received greater than one week of oral steroids in the previous three months Exclusively breastfed infants will be excluded from the study as their nutrient intake cannot accurately assessed must consume at least some foods or formulas We will include patients if they have asthma eczema or both There will be no control group recruited for the study as comparisons will be made within the study population
Subjects will be recruited from the Asthma Allergy Immunology Clinic at the main campus of Childrens Hospital of Wisconsin At the first visit with the dietitian subjects will be enrolled and consent will be obtained Height weight and head circumference until 2 YO will be measured and recorded using standard procedures The Mealtime Behavior Questionnaire MBQ and Feeding Strategies Questionnaire FSQ will be filled out by the parent or guardian Demographic data and medical history will be obtained Heightlength weight and head circumference from the first allergist visit will be obtained from the medical record and recorded for use in the study A multiple-pass 24-hour recall will be completed In addition they will receive standardized nutrition intervention to include nutrition assessment food allergy education and general nutrition education
The participant will attend a second visit with the dietitian Height weight and head circumference will be measured and recorded using standard procedures A multiple-pass 24-hour recall will be completed The participants parent or guardian will complete the MBQ and FSQ Follow-up nutrition intervention will include nutrition reassessment food allergy education as needed and general nutrition education as needed
All aspects of this study with the exception of MBQ and FSQ are the current standard of care in the Asthma Allergy and Immunology clinic for patients with multiple food allergies
Subjects will be recruited from the Asthma Allergy Immunology Clinic at the main campus of Childrens Hospital of Wisconsin At the first visit with the dietitian subjects will be enrolled and consent will be obtained Height weight and head circumference until 2 YO will be measured and recorded using standard procedures The Mealtime Behavior Questionnaire MBQ and Feeding Strategies Questionnaire FSQ will be filled out by the parent or guardian Demographic data and medical history will be obtained Heightlength weight and head circumference from the first allergist visit will be obtained from the medical record and recorded for use in the study A multiple-pass 24-hour recall will be completed In addition they will receive standardized nutrition intervention to include nutrition assessment food allergy education and general nutrition education
The participant will attend a second visit with the dietitian Height weight and head circumference will be measured and recorded using standard procedures A multiple-pass 24-hour recall will be completed The participants parent or guardian will complete the MBQ and FSQ Follow-up nutrition intervention will include nutrition reassessment food allergy education as needed and general nutrition education as needed
All aspects of this study with the exception of MBQ and FSQ are the current standard of care in the Asthma Allergy and Immunology clinic for patients with multiple food allergies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None