Cystic Fibrosis in ChildrenNCT06109675
Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status
A study testing Nutrition Education in people with Cystic Fibrosis in Children, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2021to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?
- Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education?
- 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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Nutrition Education
- Keywords
- cystic fibrosis, nutrition education, nutritional status
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Not described Receives: Behavioral: Nutrition Education |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Beginning of the study, 1st and 3rd months of the study
Secondary outcomes (1)
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.
Measured: Beginning of the study, 1st and 3rd months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start2 Sep 2021
- Primary completion2 Sep 2022
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Pehlivan, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109675
- Sponsor's protocol ID
- CyfNutEdu
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status
- ClinicalTrials.gov ID
- NCT06109675
- Acronym / sponsor ID
- CyfNutEdu
- Conditions
- Cystic Fibrosis in Children
- Keywords
- cystic fibrosis, nutrition education, nutritional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?
- Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: Nutrition Education |
| Control group | No intervention | – |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition EducationAll 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. | Behavioural | Education group |
Primary outcome
Malnutrition rate in children with cystic fibrosis
Time frame: Beginning of the study, 1st and 3rd months of the study
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.
Malnutrition rate in children with cystic fibrosis
Time frame: Beginning of the study, 1st and 3rd months of the study
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.
1 secondary outcome
The rate at which macronutrient and micronutrient consumption of children participating in the study meets the Recommended Dietary Allowance (RDA).
Time frame: Beginning of the study, 1st and 3rd months of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Cystic Fibrosis in Children, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition rate in children with cystic fibrosis (time frame: Beginning of the study, 1st and 3rd months of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.