Down SyndromeNCT07330128
Caregiver-Involved Nutrition Education in Down Syndrome
A study testing Caregiver-Involved Nutrition Education in people with Down Syndrome, run by Hülya YILMAZ ÖNAL at 1 site in Turkey (Türkiye).
Trial summary
This single-arm, quasi-experimental pre-post study evaluated an 8-week online nutrition education program for individuals with Down syndrome and their caregivers in Ataşehir, Istanbul, Türkiye. Thirty-one individuals with Down syndrome and 31 caregivers (n=62) completed the program. Read more about this study
- Who is it for?
- Ages 6 to 66 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Caregiver-Involved Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2024to 30 Jul 2024
- 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 6 to 66 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteered to participate and provided informed consent (caregiver/parent consent).
- Individuals with Down syndrome who were able to express their preferences. Caregivers/parents with sufficient digital knowledge and skills to participate in online procedures and training sessions.
Who cannot join
- Individuals with Down syndrome and/or caregivers/parents who did not have sufficient digital knowledge and skills to participate in online procedures.
- Individuals with Down syndrome and/or caregivers/parents who did not maintain continuity in the study (e.g., did not complete the intervention and/or pre-/post-assessments).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent/Caregiver-Involved Nutrition Education in Down Syndrome: A Single-Group Pre-Post Quasi-Experimental Study
This single-arm, quasi-experimental pre-post study evaluated an 8-week online nutrition education program for individuals with Down syndrome and their caregivers in Ataşehir, Istanbul, Türkiye. Thirty-one individuals with Down syndrome and 31 caregivers (n=62) completed the program. Dietary behaviors, 3-day dietary intake, anthropometric measurements, and caregiver nutrition literacy were assessed before and after the intervention.
Read the detailed description
Participants were recruited through the Turkey Down Syndrome Association (Ataşehir, Istanbul). Eligible participants were individuals with Down syndrome who could express preferences and caregivers with sufficient digital skills to complete online procedures. Although 39 individuals initially agreed to participate, the study was completed with 31 individuals with Down syndrome and their caregivers (n=62) after exclusions for eligibility and continuity.
Data were collected using a Down Syndrome Individual Information Form, the Nutrition Behavior Scale, a 3-day dietary intake record (including one weekend day; analyzed in BeBİS), a Caregiver Information Form, the Adult Nutrition Literacy Assessment Tool, and Down syndrome-specific growth charts (Zemel et al., 2015; 2-20 years).
The intervention consisted of an 8-week basic nutrition education program delivered via live video conferencing. Individuals with Down syndrome received weekly sessions of approximately 15 minutes focusing on food groups, healthy eating principles, reducing sugary/packaged foods, increasing daily physical activity, and adequate water intake. Caregivers received four modules of approximately 30 minutes covering healthy eating principles, food groups, physical activity, common comorbidities and metabolic changes in Down syndrome, and key considerations in nutrition therapy. Illustrated and graphical slide materials were shared during sessions and sent to caregivers afterward via online messaging.
- Conditions
- Down Syndrome
- Being tested
- Caregiver-Involved Nutrition Education
- Keywords
- Health Education, Nutritional Status, Anthropometry
- Medical subject headings
- Down Syndrome, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver-Involved Nutrition EducationBehavioural
An 8-week online nutrition education program delivered via live video conferencing with slide-based materials shared during sessions and sent afterward to caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education (Caregiver-Involved) | Experimental | Participants received an 8-week online nutrition education program. Individuals with Down syndrome attended weekly sessions (~15 minutes) focusing on understanding food groups, adopting healthy eating principles, reducing sugary/packaged foods, increasing daily physical activity, and emphasizing adequate daily water intake. Caregivers received four modules (~30 minutes each) covering healthy eating principles, food groups, physical activity, common comorbidities and metabolic changes in Down syndrome, and key considerations in nutrition therapy. Sessions were delivered via live video conferencing with slide-based materials shared during sessions and sent afterward via online messaging. Receives: Behavioral: Caregiver-Involved Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary behavior (Nutrition Behavior Scale score)
Change in dietary behavior score measured using the Nutrition Behavior Scale (total score range -14 to +14; converted to a 0-100% healthy consumption score).
Measured: Baseline (pre-intervention) and immediately after the 8-week education program.
Secondary outcomes (3)
Dietary intake from 3-day diet records (energy and selected nutrients)
Change in daily energy and nutrient intakes derived from 3-day dietary intake records (including one weekend day) and analyzed using the BeBİS nutrition analysis software (e.g., energy, protein, dietary fiber, selected vitamins/minerals, n-3 and n-6 fatty acids).
Measured: Baseline (pre-intervention) and immediately after the 8-week education program.
BMI
Change in body weight and BMI
Measured: Baseline (pre-intervention) and immediately after the 8-week education program.
Anthropometric measurements
Change in anthropometric measurements (e.g., age-appropriate interpretation using Down syndrome-specific growth charts where applicable).
Measured: Baseline (pre-intervention) and immediately after the 8-week education program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start27 Feb 2024
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pre-post design (one group assessed before and after an 8-week online nutrition education program)
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hülya YILMAZ ÖNAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hülya YILMAZ ÖNAL, Istanbul Medeniyet University
- Investigators
- Hülya Yılmaz Önal, Assoc. Prof., Principal investigator, stanbul Medeniyet University, Department of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330128
- Sponsor's protocol ID
- 2024/1, dated 23 January 2024
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent/Caregiver-Involved Nutrition Education in Down Syndrome: A Single-Group Pre-Post Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07330128
- Acronym / sponsor ID
- 2024/1, dated 23 January 2024
- Conditions
- Down Syndrome
- Keywords
- Health Education, Nutritional Status, Anthropometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hülya YILMAZ ÖNALUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Jan 2026 (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.
This single-arm, quasi-experimental pre-post study evaluated an 8-week online nutrition education program for individuals with Down syndrome and their caregivers in Ataşehir, Istanbul, Türkiye. Thirty-one individuals with Down syndrome and 31 caregivers (n=62) completed the program. Dietary behaviors, 3-day dietary intake, anthropometric measurements, and caregiver nutrition literacy were assessed before and after the intervention.
Detailed description
Participants were recruited through the Turkey Down Syndrome Association (Ataşehir, Istanbul). Eligible participants were individuals with Down syndrome who could express preferences and caregivers with sufficient digital skills to complete online procedures. Although 39 individuals initially agreed to participate, the study was completed with 31 individuals with Down syndrome and their caregivers (n=62) after exclusions for eligibility and continuity.
Data were collected using a Down Syndrome Individual Information Form, the Nutrition Behavior Scale, a 3-day dietary intake record (including one weekend day; analyzed in BeBİS), a Caregiver Information Form, the Adult Nutrition Literacy Assessment Tool, and Down syndrome-specific growth charts (Zemel et al., 2015; 2-20 years).
The intervention consisted of an 8-week basic nutrition education program delivered via live video conferencing. Individuals with Down syndrome received weekly sessions of approximately 15 minutes focusing on food groups, healthy eating principles, reducing sugary/packaged foods, increasing daily physical activity, and adequate water intake. Caregivers received four modules of approximately 30 minutes covering healthy eating principles, food groups, physical activity, common comorbidities and metabolic changes in Down syndrome, and key considerations in nutrition therapy. Illustrated and graphical slide materials were shared during sessions and sent to caregivers afterward via online messaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pre-post design (one group assessed before and after an 8-week online nutrition education program)
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education (Caregiver-Involved) | Experimental | Behavioral: Caregiver-Involved Nutrition EducationParticipants received an 8-week online nutrition education program. Individuals with Down syndrome attended weekly sessions (~15 minutes) focusing on understanding food groups, adopting healthy eating principles, reducing sugary/packaged foods, increasing daily physical activity, and emphasizing adequate daily water intake. Caregivers received four modules (~30 minutes each) covering healthy eating principles, food groups, physical activity, common comorbidities and metabolic changes in Down syndrome, and key considerations in nutrition therapy. Sessions were delivered via live video conferencing with slide-based materials shared during sessions and sent afterward via online messaging. |
Who may qualify
- Ages
- 6 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteered to participate and provided informed consent (caregiver/parent consent).
- Individuals with Down syndrome who were able to express their preferences. Caregivers/parents with sufficient digital knowledge and skills to participate in online procedures and training sessions.
Key exclusion criteria (2 listed)
- Individuals with Down syndrome and/or caregivers/parents who did not have sufficient digital knowledge and skills to participate in online procedures.
- Individuals with Down syndrome and/or caregivers/parents who did not maintain continuity in the study (e.g., did not complete the intervention and/or pre-/post-assessments).
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 |
|---|---|---|
| Caregiver-Involved Nutrition EducationAn 8-week online nutrition education program delivered via live video conferencing with slide-based materials shared during sessions and sent afterward to caregivers. | Behavioural | Nutrition Education (Caregiver-Involved) |
Primary outcome
Dietary behavior (Nutrition Behavior Scale score)
Time frame: Baseline (pre-intervention) and immediately after the 8-week education program.
Change in dietary behavior score measured using the Nutrition Behavior Scale (total score range -14 to +14; converted to a 0-100% healthy consumption score).
3 secondary outcomes
Dietary intake from 3-day diet records (energy and selected nutrients)
Time frame: Baseline (pre-intervention) and immediately after the 8-week education program.
BMI
Time frame: Baseline (pre-intervention) and immediately after the 8-week education program.
Anthropometric measurements
Time frame: Baseline (pre-intervention) and immediately after the 8-week education program.
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 9 Jan 2026.
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Down Syndrome
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.
Hülya Yılmaz Önal, Assoc. Prof. principal investigator
stanbul Medeniyet University, Department of Nutrition and Dietetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver-Involved Nutrition Education in people with Down Syndrome, run by Hülya YILMAZ ÖNAL 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 2 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 9 Jan 2026. 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?
Dietary behavior (Nutrition Behavior Scale score) (time frame: Baseline (pre-intervention) and immediately after the 8-week education program.). 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 9 Jan 2026.