Caregiver-Involved Nutrition Education in Down Syndrome

January 8, 2026 updated by: Hülya YILMAZ ÖNAL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition Education (Caregiver-Involved)
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.
Behavioral: Caregiver-Involved Nutrition Education
An 8-week online nutrition education program delivered via live video conferencing with slide-based materials shared during sessions and sent afterward to caregivers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (pre-intervention) and immediately after the 8-week education program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake from 3-day diet records (energy and selected nutrients)
Time Frame: Baseline (pre-intervention) and immediately after the 8-week education program.
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).
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.
Change in body weight and BMI
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.
Change in anthropometric measurements (e.g., age-appropriate interpretation using Down syndrome-specific growth charts where applicable).
Baseline (pre-intervention) and immediately after the 8-week education program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hülya YILMAZ ÖNAL

Investigators

  • Principal Investigator: Hülya Yılmaz Önal, Assoc. Prof., stanbul Medeniyet University, Department of Nutrition and Dietetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/1, dated 23 January 2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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