Caregiver-Involved Nutrition Education in Down Syndrome

NCT07330128 | Completed

• 1 other identifier: 2024/1, dated 23 January 2024
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. Dietary behaviors, 3-day dietary intake, anthropometric measurements, and caregiver nutrition literacy were assessed before and after the intervention.

Conditions

Down Syndrome

Keywords

Health Education; Nutritional Status; Anthropometry

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

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

• BMI

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

• Anthropometric measurements

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

Study Arms (1)

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.

Behavioral: Caregiver-Involved Nutrition Education

Interventions

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.

Nutrition Education (Caregiver-Involved)

Eligibility Criteria

• Age: 6 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hülya YILMAZ ÖNAL: lead

Study Sites (1)

Turkey Down Syndrome Association (

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down Syndrome; Health Education

Condition Hierarchy (Ancestors)

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

Study Officials

• Hülya Yılmaz Önal, Assoc. Prof.

  stanbul Medeniyet University, Department of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-arm pre-post design (one group assessed before and after an 8-week online nutrition education program)

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: February 27, 2024
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

TU (1)