Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status

NCT06109675 | Completed

• 1 other identifier: CyfNutEdu
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to assess the nutritional status of children diagnosed with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition education given to the mothers of the patients on the nutritional status of the children and the nutritional knowledge of the mothers, and to compare them with the control group.. The main questions it aims to answer are:

1. 1.Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?
2. 2.Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education?
3. 3.Will the nutrition knowledge test scores of mothers of children with cystic fibrosis in education group on "Nutrition in Cystic Fibrosis" increase after nutrition education?

Conditions

Cystic Fibrosis in Children

Keywords

cystic fibrosis; nutrition education; nutritional status

Outcome Measures

Primary Outcomes (2)

• Malnutrition rate in children with cystic fibrosis

  According to the World Health Organisations (WHO) standarts; children who are more than 2 SD below the reference median are considered to be malnourished to be stunted, wasted or to be underweight. Children with measurements below 3 SD (a Z-Score of less than-3) are considered to be severely malnourished.

  Beginning of the study, 1st and 3rd months of the study

• Malnutrition rate in children with cystic fibrosis

  All children will also be evaluated according to the percentile recommendations in the guide of the European Cystic Fibrosis Society (ECFS). According to the ECFS guideline, those with height for age and BMI for age below the 50th percentile are classified as undernourished.

  Beginning of the study, 1st and 3rd months of the study

Secondary Outcomes (1)

• The rate at which macronutrient and micronutrient consumption of children participating in the study meets the Recommended Dietary Allowance (RDA).

  Beginning of the study, 1st and 3rd months of the study

Study Arms (2)

Education group

EXPERIMENTAL

Behavioral: Nutrition Education

Control group

NO INTERVENTION

Interventions

Nutrition Education BEHAVIORAL

All mothers in this group will be given 3 nutrition education sessions including detailed informations on Nutrition Therapy in Cystic Fibrosis. In addition to the education sessions, an informational booklet and a high-energy sample recipe booklet will be given.

Education group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mothers included in the research must have responded to the KIFDER (Cystic Fibrosis Association in Turkey) call.
• Children of mothers included in the research must have been officially diagnosed with cystic fibrosis.
• Mothers included in the research mustn't receive any nutrition education beforehand.
• Children of mothers included in the research mustn't be regularly followed by a dietitian.

You may not qualify if:

• Children of mothers included in the research mustn't have a feeding tube.
• Children of mothers included in the research mustn't be diagnosed with any other disease known to affect growth.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol Unıversity

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd(c)

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 31, 2023
• Study Start: September 2, 2021
• Primary Completion: September 2, 2022
• Study Completion: August 2, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)