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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06109675
Enrollment
46
Registered
2023-10-31
Start date
2021-09-02
Completion date
2023-08-02
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis in Children

Keywords

cystic fibrosis, nutrition education, nutritional status

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.

Interventions

BEHAVIORALNutrition Education

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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Malnutrition rate in children with cystic fibrosisBeginning of the study, 1st and 3rd months of the studyAccording 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.

Secondary

MeasureTime frameDescription
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 studyRecommended 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026