NCT07741500

Brief Summary

1\. Introduction This 3-week single case intervention study is funded by the Horizon Europe Research Program and is part of the VIPPSTAR project (Project 101156763 - VIPPSTAR "Visually Impaired children and adolescents: bridging the gap with Personalized Prevention Strategies, Tools, Approaches, and Resources). Within this project, the Belgian consortium will focus on the development of body image in relation to the social media use of children (10-11 years old) and adolescents (12-18 years old) with visual impairment (VI). This intervention study builds upon the insights done in earlier studies within the project, a focus group study and daily diary study. In the intervention study, children and adolescents with visual impairment will complete digital body image exercises through the first version of VIPPSTAR app. It is important to note that the data collection for this particular study will be limited to Flanders, Belgium, and will not extend to the other countries involved in the VIPPSTAR project. Furthermore, the ethical approval obtained for this study is specifically for collecting data from Flemish participants only, ensuring compliance with local ethical guidelines and regulations.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started May 2027

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 3, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 25, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Visual impairmentCerebral visual impairmentDigital intervention

Outcome Measures

Primary Outcomes (8)

  • State body satisfaction

    Today, I felt satisfied with my appearance. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true.

    8 weeks, asked 16 times

  • State self-esteem

    Today, I have high self-esteem. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true

    8 weeks, asked 16 times

  • State body surveillance

    Item 1: Today, I compared how I look with how other people look. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true. Item 2: Throughout the day, I thought about how I look many times. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true.

    8 weeks, asked 16 times

  • State functionality appreciation

    Item 1: I appreciate my body for what it is capable of doing. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true. Item 2: I am grateful that my body enables me to engage in activities that I enjoy or find important. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true. Item 3: I respect my body for the functions it performs. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true.

    8 weeks, asked 16 times

  • Social media use

    Did you use social media today? 1=Yes, 2=No

    8 weeks, asked 16 times

  • State social media physical appearance comparisons

    Item 1: When using social media, I compare my physical appearance to the physical appearance of others. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true Item 2: When using social media, I compare how Ia m dressed to how other people are dressed. 1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true Item 3: When using social media, I sometimes compare my figure to the figures of other people.1=not true at all, 2=not true, 3=sometimes not true, sometimes true, 4=true, 5=completely true

    8 weeks, asked 16 times

  • State cognitive social media literacy

    If you used social media today and saw posts/stories of other people, how critically did you think about the appearance of the people in those posts/stories? For example, did you think about if something was edited, if this person looked realistic, which effects the post could have on others, how much this person wanted to get likes and comments on their post. 1=Not critically at all, 2=not critically, 3=neutral, 4=critically, 5=very critically

    8 weeks, asked 16 times

  • State affective social media literacy

    Item 1: Did you have a negative feeling due to using social media today? For example feeling jealous or angry about your body and appearance by the things you saw or did on social media. 1=Yes (follow up question) 2=no (no question) Item 2: When you did not feel good about yourself, did you do anything to change that and make yourself feel better? For example closing social media, unfollowing people, looking at profiles that give you a positive feeling about yourself and your appearance, or talking to someone about how you feel. 1=Not critically at all, 2=not critically, 3=neutral, 4=critically, 5=very critically

    8 weeks, measured 16 times

Study Arms (1)

(C)VI

EXPERIMENTAL

Body image intervention

Behavioral: Body image intervention

Interventions

Digital body image and social media literacy intervention

(C)VI

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with (C)VI
  • Participants should be aged between 10-18 years old
  • Participants should be able to understand Dutch sufficiently
  • Participants should be cognitively able to comprehend the questions
  • A completed ICF by the parent if the participant is under 18 years of age and a completed assent form by the participant

You may not qualify if:

  • Intellectual disability of such severity that they are unable to respond to the questions (as indicated by parents)
  • Non-Dutch Speaking (as indicated by parents)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty Social Sciences KU Leuven, Leuven, 3000

Leuven, 3000, Belgium

Location

UZ Leuven, Leuven, 3000

Leuven, Belgium

Location

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Related Links

MeSH Terms

Conditions

Vision DisordersBlindness, Cortical

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBlindness

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single case experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

August 3, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

August 3, 2026

Record last verified: 2026-06

Locations