Viewing Study NCT04665557



Ignite Creation Date: 2024-05-06 @ 3:33 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04665557
Status: COMPLETED
Last Update Posted: 2023-07-25
First Post: 2020-09-29

Brief Title: Evaluating Dove Confident Me Single Session in Indonesia
Sponsor: University of the West of England
Organization: University of the West of England

Study Overview

Official Title: Evaluating Dove Confident Me Indonesia A School-Based Single Session Intervention to Improve Body Image and Wellbeing Among Indonesian Adolescents
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Negative body image is an important public health concern for young people due to its prevalence and detrimental impact on young peoples health education and social life Encouragingly a number of interventions have been designed to improve adolescent body image in school settings with promising results However the vast majority of studies testing these interventions are conducted in high-income English speaking countries despite increasingly recognition that negative body image is a global concern As such it is important to develop and disseminate interventions to foster positive body image among adolescents in low-to-middle income countries too

Research indicates high prevalence rates of negative body image among adolescents in many Asian countries Indonesia - the focus of the present research - is an emerging middle-income country in South East Asia A recent U-Report Poll UNICEF 2020 found almost 80 of the young people surveyed wanted to change something about their appearance suggesting a degree of body dissatisfaction and approximately 50 stopped themselves from doing something that was important to them because of appearance concerns Moreover according to the same poll over 90 of Indonesian adolescents surveyed reported to wanting to learn ways to improve their body image in school or online

To date no body image interventions have been adapted and trialled in Indonesia Therefore this project aims to evaluate the effectiveness as well as the acceptability and feasibility of a specially adapted version of Dove Confident Me Single Session among Indonesian adolescents that will be integrated into UNICEFs Life Skills Education curriculum Notably the session has been designed to be feasible to deliver in low-resource schools eg that do not access to the internet or facilities to show videos or PowerPoint slides

To assess the acceptability feasibility and effectiveness of the intervention the study will compare the body image and well-being of students who take part in the programme to students who do not take part in any programme classes as usual Investigators will also gather in-depth feedback from students and teachers via focus groups and surveys in order to inform future improvement of the programme for wider implementation

To undertake this project the investigators will recruit students and teachers from approximately 10 state junior secondary schools in Indonesia via a local research agency Students will complete questionnaire assessments of body image and well-being before and after programme period and again 8 weeks later to assess longer-term benefits

COVID response In light of the ongoing pandemic some research activities will take place online Decisions on delivery format online in-person hybrid were made on the basis of continued risk assessments and considerations of local government guidelines
Detailed Description: Detailed COVID Response Description Though the intervention was specifically designed to be delivered in person and avoided the use of technology to make it accessible to as many Indonesian adolescents as possible circumstances with COVID-19 have meant that aspects of trial need to be conducted online to minimise undue harm and the spread of infection Decisions on delivery format were based on regular risk assessments and considerations of local government guidelines Accordingly the internal pilot was conducted entirely online as most schools were exclusively offering remote learning and the risk in the area was high In contrast shortly following the commencement of the main trial schools in Surabaya returned to 100 in person teaching January 2022 Consequently some research activities including the lesson took place in school while sticking to health and safety measures eg social distancing wearing masks etc

Teacher training will include self-directed learning via UNICEFs teacher training e-module for Life Skills Curriculum which includes the intervention of focus on body image Teachers will then attend two online training sessions with a member of the research team who is trained in delivering the intervention These sessions will run through background knowledge about body image propose how we expect the lesson to look give the opportunity for teachers to ask questions and explore common questionsstatements from students

Schools will be recruited for the study via email correspondence from the research agency in Indonesia and information sheets will be sent out to parentsguardians Parentsguardians will provide informed consent to the school Students will provide informed consent to the school and during the baseline assessment Students will complete the surveys across three time points via Qualtrics on personal devices at home or at school The acceptability focus groups with teachers and students from the intervention condition will take place via a video conferencing platform such as Zoom The intervention will be delivered online via video conferencing platform

To ensure this method of the trial is feasible we need to ensure students have access to a device laptop or iPad have a stable internet connection and are familiar with video conferencing platforms for learning To meet these demands we will recruit in higher SES areas

Further given that we did not initially plan to conduct any aspects of the trial online we ran an internal acceptability pilot That is we tested the feasibility and acceptability of key study elements - ie administering the surveys online across three timepoints and delivering the intervention online with two classes Additionally we conducted small focus groups with students to access their feedback on the intervention If the data quality from the pilot is poor and the engagement in the lesson is low we will suspend the trial until schools resume face to face learning and the COVID-19 risk is much lower eg when there is widespread uptake of the vaccine

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HAS-HSS-18-098 OTHER University of the West of England PASS reference None