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

Not Applicable

Completed

• Conditions: Cystic Fibrosis in Children
• Interventions: Behavioral: Nutrition Education

• Registration Number: NCT06109675
• Lead Sponsor: Medipol University

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. Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?

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. 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?

Mothers of children diagnosed with cystic fibrosis will participate in the study as a result of the call of the Cystic Fibrosis Association in Turkey. Mothers participating in the study will be divided into 2 groups. While the mothers in the first group will be given nutrition education 3 times a week, 1 hour a day, no education session will be given to the mothers in the control group. The nutritional status and nutrient consumption of children in the training group and the control group will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Primary Completion: 2022-09-02
• Study Completion: 2023-08-02
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education group	Nutrition Education	-

Primary Outcome Measures

Name	Time	Method
Malnutrition rate in children with cystic fibrosis	Beginning of the study, 1st and 3rd months of the study	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.

Secondary Outcome Measures

Name	Time	Method
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	Recommended Dietary Allowance (RDA): Average daily level of intake sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals; often used to plan nutritionally adequate diets for individuals.The macro and micronutrient RDA is determined by the Food and Nutrition Board of the National Academies of Sciences Engineering, and Medicine.

Trial Locations

Locations (1)

Istanbul Medipol Unıversity; 🇹🇷 Istanbul, Turkey