An interventional study of Nutrition Education in Cystic Fibrosis in Children, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Medipol University · Not applicable, Interventional, and Supportive care
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.
1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's enrollment of 46 is above the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Medipol University is the lead sponsor of 320 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Behavioral: 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.
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.
Time frame: 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.
Time frame: Beginning of the study, 1st and 3rd months of the study
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.
Time frame: Beginning of the study, 1st and 3rd months of the study
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Plan to share: No
Ran from Sep 2021 to primary completion in Sep 2022, 12 months.
Of 213 non-industry interventional studies with no phase under Cystic Fibrosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 49. This study's 12 months is below that.
Counting every sponsor, half of 226 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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