The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status

NCT04576845 | Unknown

• 1 other identifier: NazliKubra2020
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Cow's milk allergy (CMA) is the most common Food Allergy (FA) in children, and the essential strategy in prevention is avoiding the allergens that may cause potentially life-threatening reactions. The primary developmental task of early childhood is the creation of healthy eating habits. The diagnosis of FA in this period can lead to permanent changes in the life of the child and her family. In early childhood, parents are often responsible for all aspects of FA management because children are too young to understand the complexity of avoiding allergens. Children often do not have the skills to implement FA management. Parents are advised to follow a special weaning diet, avoiding any type of cow's milk, usually at least 1 year old. However, depending on the clinical improvement, it can be recommended to continue this exclusion diet for much longer. Thus, many children have to exclude a large group of food from their diets, which is critical for their growth, development, and eating habits. This may raise mealtime behavioral anxiety in a child with a FA. Eating behavioral anxieties are also very common in healthy, typically developing children. Even 25% to 45% of normally developing children's parents report concerns about their child's nutritional and mealtime behaviors, including the destructive child behaviors (eg., refusal of foods, food selectivity, and getting off the table). In children with food allergies, monitoring long-term growth after the diet is another important issue. Growth problems were reported in 21% of children with FA diagnosed with malnutrition. Most studies focused on the effect of changes in eating behavior on growth during an elimination diet or in short term intervals. Its long-term effects have only been analyzed in a few studies. We aimed to investigate the eating behaviors, nutritional status, and growth of young children (ages of 2 to 6) who had a strict diet due to CMA in early childhood (ages of 0-2).

Conditions

Nutrient Deficiency; Eating Behavior; Cow Milk Allergy; Growth Disorders

Keywords

Cow's Milk Protein Allergy (CMA); Children's Eating Behavior Questionnaire (CEBQ); Elimination diet; Eating behavior; Food fussiness

Outcome Measures

Primary Outcomes (1)

• Eating behavior will be evaluated by CEBQ scoring system.

  The 8 subscales of CEBQ and their interpretation are: The sub-scales Satiety Responsiveness (SR) (7 items), Slowness in Eating (SE) (4 items), Emotional Under Eating (EUE) (4 items), and Food Fussiness (FF) (3 items) assess "food avoidance", while the sub-scales Food Responsiveness (FR) (5 items), Enjoyment of Food (EF) (5 items), Desire to Drink (DD) (3 items), and Emotional Overeating (EOE) (4 items) assess "food approach". Higher scores indicate a stronger display of food approach or food avoidance (except FF) behavior. In the Turkish version of the CEBQ, a lower score for FF means a stronger display for fussy eating. Therefore, while calculating the food avoidance total score, reversed items of FF were summed with SR, SE, and EUE. The food approach total score will be calculated by the summation of FR, EF, DD, and EOE.

  One day

Secondary Outcomes (5)

• BeBiS software version 7.2 will be used to calculate the daily intake of energy, macronutrients, micronutrients, and dairy products.

  (2 weekdays and 1 weekend day).

• The anthropometric evaluation of children respecting body weight.

  One day

• The anthropometric evaluation of children respecting height.

  One day

• The anthropometric evaluation of children with calculation of BMI.

  One day

• Z-score calculations of all participants using WHO ANTHRO program.

  One day

Study Arms (1)

Study Group

The study will be performed on Caucasian origin children who are among 2 to 6 years of age. The study group will be composed of children (n=31) who had CMA (Ig E-mediated and/or non-Ig E-mediated and/or mixed type) proved with oral food challenge tests in their early childhood (in ages of 0-2). The inclusion criteria to the study group will be to undergo a Cow's milk elimination (CME) diet or took a hypoallergenic formula in 0-2 years of age for at least 3 months or longer due to CMA allergy and improved afterward, and/or to eliminate other nutrients (e.g., eggs, potatoes, wheat flour, soybean, etc.) other than cow's milk between the ages of 0-2 for at least 3 months or longer, and/or to add these nutrients back to their diet in the last 3 months, and/or not receiving hypoallergenic formula for the last 3 months, not to be on the CME diet at present. Thus, no children in the study and control groups will be on a dietary restriction during the study.

Other: Survey

Interventions

Survey OTHER

The children's eating behavior will be evaluated with Turkish validated Children's Eating Behavior Questionnaire - (CEBQ) by interviewing mothers face to face. The CEBQ is a Likert type, parent-report rating scale measuring the variation in eating behavior in children. The CEBQ consists of 35 items comprising eight subscales, each containing 3 to 6 items. Parents will be asked to rate their child's eating behavior on a five-point scale (never, rarely, sometimes, often, always; 1-5, respectively).

Also known as: The children's eating behavior will be evaluated with Turkish validated Children's Eating Behavior Questionnaire - (CEBQ)

Study Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The children eligible for the study group will be enrolled from the pediatric allergy and immunology outpatient unit. The control group children will be selected from the health visitor clinics of Pediatrics. All children will be enrolled in the study will be Caucasian origin between 2 to 6 years of age. The study group will be composed of children (n=31) who had CMA (Ig E-mediated and/or non-Ig E-mediated and/or mixed type) proved by oral food challenge test in their early childhood (in ages of 0-2). The control group (n=31) will include healthy children who had never been on a diet throughout their lives.

You may qualify if:

• to undergo a Cow's milk elimination (CME) diet or took a hypoallergenic formula in 0-2 years of age for at least 3 months or longer due to CMA allergy
• improvement of CMA after receiving CME diet,
• to eliminate other nutrients (e.g., eggs, potatoes, wheat flour, soybean, etc.) other than cow's milk between the ages of 0-2 for at least 3 months or longer,
• to add other nutrients (as mentioned in criterion 3) back to their diet in the last 3 months,
• not receiving hypoallergenic formula for the last 3 months,
• not to be on the CME diet at present.

You may not qualify if:

• Children with any disease that may affect eating behavior, nutritional status, and growth.
• The children with a diagnosis of a disease mentioned below will be excluded from the study.
• Children with a diagnosis of chronic infection / inflammatory diseases,
• cystic fibrosis,
• congenital heart disease,
• chronic kidney failure,
• diabetes,
• gastroesophageal reflux,
• dysfunction of swallowing,
• anatomical, cognitive and/or impairment of speech,
• autoimmune diseases (SLE, RA, thyroid, etc.),
• congenital genetic diseases,
• immune deficiency,
• autism,
• attention deficit hyperactivity,

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Gülhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (4)

• Maslin K, Grundy J, Glasbey G, Dean T, Arshad SH, Grimshaw K, Oliver E, Roberts G, Venter C. Cows' milk exclusion diet during infancy: Is there a long-term effect on children's eating behaviour and food preferences? Pediatr Allergy Immunol. 2016 Mar;27(2):141-6. doi: 10.1111/pai.12513. Epub 2016 Jan 21.

  PMID: 26592369 RESULT

• Meyer R, Rommel N, Van Oudenhove L, Fleming C, Dziubak R, Shah N. Feeding difficulties in children with food protein-induced gastrointestinal allergies. J Gastroenterol Hepatol. 2014 Oct;29(10):1764-9. doi: 10.1111/jgh.12593.

  PMID: 24720353 RESULT

• Mukkada VA, Haas A, Maune NC, Capocelli KE, Henry M, Gilman N, Petersburg S, Moore W, Lovell MA, Fleischer DM, Furuta GT, Atkins D. Feeding dysfunction in children with eosinophilic gastrointestinal diseases. Pediatrics. 2010 Sep;126(3):e672-7. doi: 10.1542/peds.2009-2227. Epub 2010 Aug 9.

  PMID: 20696733 RESULT

• Ercan N, Tel Adiguzel K. Effect of early childhood cow's milk elimination diet on eating behaviours, nutrition and growth status at age 2-6 years. J Hum Nutr Diet. 2022 Apr;35(2):300-309. doi: 10.1111/jhn.12914. Epub 2021 Jun 16.

  PMID: 33974304 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Milk Hypersensitivity; Growth Disorders; Food Fussiness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Nazli ERCAN, MD

CONTACT

+905319957255; drnazliercan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Allergy and Immunology specialist, MD

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 6, 2020
• Study Start: October 12, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)