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

NCT ID: NCT06109675

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2023-08-02

Brief Summary

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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

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Conditions

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Cystic Fibrosis in Children

Keywords

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cystic fibrosis nutrition education nutritional status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Education group

Group Type EXPERIMENTAL

Nutrition Education

Intervention Type 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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Merve Pehlivan

Phd(c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol Unıversity

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CyfNutEdu

Identifier Type: -

Identifier Source: org_study_id