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Completed

NCT Number: NCT07330128

Caregiver-Involved Nutrition Education in Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Adherence Interventions Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Health Behavior Health Education Intellectual Disability Medication Adherence Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

6 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey Down Syndrome Association (

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Caregiver-Involved Nutrition Education

Behavioral

An 8-week online nutrition education program delivered via live video conferencing with slide-based materials shared during sessions and sent afterward to caregivers.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. BMI

    Time frame: Baseline (pre-intervention) and immediately after the 8-week education program.

    Change in body weight and BMI

  3. 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).

Sponsors and collaborators

Lead sponsor

Hülya YILMAZ ÖNAL

Other

Registry information

Official study title

Parent/Caregiver-Involved Nutrition Education in Down Syndrome: A Single-Group Pre-Post Quasi-Experimental Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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