Caregiver-Involved Nutrition Education in Down Syndrome

NCT ID: NCT07330128

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2024-07-30

Brief Summary

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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

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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

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Down Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm pre-post design (one group assessed before and after an 8-week online nutrition education program)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Caregiver-Involved Nutrition Education

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hülya YILMAZ ÖNAL

OTHER

Sponsor Role lead

Responsible Party

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Hülya YILMAZ ÖNAL

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hülya Yılmaz Önal, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

stanbul Medeniyet University, Department of Nutrition and Dietetics

Locations

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Turkey Down Syndrome Association (

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/1, dated 23 January 2024

Identifier Type: -

Identifier Source: org_study_id

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