Clinical trial NCT06109675: Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status
Official title: Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: cystic fibrosis
nutrition education
nutritional status
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Malnutrition rate in children with cystic fibrosis
timeFrame: Beginning of the study, 1st and 3rd months of the study
measure: Malnutrition rate in children with cystic fibrosis
timeFrame: Beginning of the study, 1st and 3rd months of the study
Secondary outcomes:
measure: The rate at which macronutrient and micronutrient consumption of children participating in the study meets the Recommended Dietary Allowance (RDA).
timeFrame: Beginning of the study, 1st and 3rd months of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol Unıversity
Study officials:
References: