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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate at which macronutrient and micronutrient consumption of children participating in the study meets the Recommended Dietary Allowance (RDA). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol Unıversity | Istanbul | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2021 | Oct 19, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Beginning of the study, 1st and 3rd months of the study |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |