Body Image Clinical Trial
Official title:
A Randomised Control Trial Evaluating a Comic-based School Intervention to Promote Body Confidence and Related Outcomes Among Adolescents in India
Verified date | April 2023 |
Source | University of the West of England |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Body dissatisfaction is a leading concern for young people and can have serious health consequences. Emerging approaches for improving body image are effective among adolescents in the school setting. However, the majority of trials are conducted in high-income westernised countries, despite body dissatisfaction being increasingly recognised as a global concern. As such, it is important to develop and disseminate interventions to promote body confidence among adolescents in in low-to-middle income countries, too. One country where body image concerns are becoming an increasing issue is India. The investigators recently finished developing and evaluating a body image programme among adolescents in New Delhi, India; which found immediate and 3-month improvements in body image, disordered eating, self-esteem, and other related outcomes. Whilst these findings offer an effective body image programme for school students in urban areas of India, this may not be feasible for schools in more rural and lower socio-economic areas in India. The aim of the present study is therefore to conduct an acceptability study, followed by a randomised controlled trial (RCT), of a comics-based body image programme among adolescents in a semi-rural area of India (Rajasthan), in order to understand its acceptability, feasibility, and preliminary efficacy. This comic-based programme will be based on Dove Confident Me, which was found to be effective among adolescents in Delhi, India. To assess the acceptability of the comic-book-based programme, interviews and focus groups will be conducted with students and teachers. This in-depth feedback will be used to optimise the programme. Next, an RCT will compare body image and well-being of students who take part in the programme to students who do not take part (classes as usual) to examine the programme's efficacy. The investigators will recruit students and teachers from schools in a rural and lower socio-economic area of India (Rajasthan). Students will complete questionnaire assessments of body image and well-being before and after the 6-session intervention (across 4 weeks), and again at 3-month follow-up to assess longer-term benefits. It is hypothesised that students who receive the intervention will have better body image and wellbeing relative to the control group at both post-intervention and follow-up.
Status | Completed |
Enrollment | 2631 |
Est. completion date | December 15, 2022 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 14 Years |
Eligibility | Inclusion criteria for schools: - Co-educational - Located in semi-rural areas of Rajasthan - Hindi-medium (i.e., Hindi should be the main medium of instruction) - Include Classes 6-8 (students aged 11 to 14 years). Exclusion criteria for schools: - Single gender schools - Located in urban areas of Rajasthan - English medium - Does not include Classes 6-8 (students aged 11 to 14 years). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Appearance Research, University of the West of England | Bristol |
Lead Sponsor | Collaborator |
---|---|
University of the West of England | BBC, UNICEF, Unilever R&D |
United Kingdom,
Diedrichs PC, Atkinson MJ, Garbett KM, Leckie G. Evaluating the "Dove Confident Me" Five-Session Body Image Intervention Delivered by Teachers in Schools: A Cluster Randomized Controlled Effectiveness Trial. J Adolesc Health. 2021 Feb;68(2):331-341. doi: — View Citation
Garbett KM, Lewis-Smith H, Chaudhry A, Shroff H, Dhillon M, White P, Diedrichs PC. Acceptability and preliminary efficacy of a school-based body image intervention in urban India: A pilot randomised controlled trial. Body Image. 2021 Jun;37:282-290. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Skin colour dissatisfaction: Purpose-built single-item measure developed for the study | Assessment of skin colour dissatisfaction using a single-item measure ('How satisfied or dissatisfied are you with the colour of your skin?'), score range 1-5. This item will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Other | Body hair dissatisfaction: Purpose-built single-item measure developed for the study. | Assessment of body hair dissatisfaction using a single-item measure ('How satisfied or dissatisfied are you with the amount of hair on your body?'), score range 1-5. This item will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Other | Appearance-based teasing: Single-item measure adapted from a previous body image intervention evaluation (Diedrichs et al, 2012). | Assessment of appearance-based teasing using an item adapted from a previous body image intervention evaluation ('How often have you been teased about the way you look?'), score range 1-5. This item will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Other | Endorsement of traditional gender roles: A 10-item purpose built scale developed for the study and based on previous scales (Mills et al., 2012; Pulerwitz & Barker, 2008; Zeyneloglu & Terzioglu, 2011). | Assessment of endorsement of traditional gender roles using a purpose-built measure based on previous scales. 10 items, mean score range 1-5. Scores are averaged, with higher scores indicating greater endorsement of traditional gender roles. This measure will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Other | ADDITIONAL: Body size satisfaction: Child Figure Rating Scale (Tiggemann & Wilson-Barrett, 1998) | Visual-based assessment of body shape satisfaction, using discrepancy score between "ideal" and "perceived" figure (9 figures of varying body size). This measure will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Other | ADDITIONAL: Skin colour satisfaction: Purpose-built single-item measure developed for the study. | Visual-based assessment of body shape satisfaction, using discrepancy score between "ideal" and "perceived" skin shade (9 varying skin shades from darker to lighter).This measure will be in Hindi. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Primary | Body esteem: Validated Hindi language version of the Body Esteem Scale for adolescents & adults: Appearance and Weight subscales (Mendelson, Mendelson & White, 2001). | Assessment of body esteem using the Appearance and Weight subscales from the Body Esteem Scale for adolescents & adults, 5-point Likert-type scale. Once the appropriate items are reverse coded, scores on all items are averaged; with lower scores indicating lower body esteem. This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Secondary | Eating pathology: Validated Hindi language version of the Eating Disorder Examination Questionnaire (Fairburn & Wilson, 1993) | Assessment of eating disorder pathology using the Eating Disorder Examination Questionnaire, 22 items, 7-point Likert-type scale. Scores on all items are averaged; with higher scores indicating greater eating pathology. This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Secondary | Internalisation of appearance ideals: Validated Hindi language version of the Sociocultural Attitudes Towards Appearance Questionnaire-3 (SATAQ-3): Internalisation-General subscale (Thompson et al., 2004) | Assessment of internalisation of appearance ideals using the Internalisation-General subscale from the Sociocultural Attitudes Towards Appearance Questionnaire-3 (SATAQ-3):9 items, mean score range 1-5. Scores are averaged, with higher scores indicating higher internalisation. This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Secondary | Life disengagement due to body image concerns: Validated Hindi language version of the Body Image Life Disengagement Questionnaire (Atkinson & Diedrichs, 2021) | Assessment of the extent to which worries or feeling bad about one's appearance has stopped the individual or is likely to stop them from engaging in life activities (e.g., going to a social event, doing physical activity, giving an opinion, going to school), 10 items, mean score range 1-4. Scores on all items are averaged; with higher scores indicating greater avoidance of activities due to appearance concerns.This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Secondary | Mood: Validated Hindi language version of the Positive and Negative Affect Scale - Children (Laurent et al., 1999) | Assessment of both positive and negative mood using the Positive and Negative Affect Schedule - Children, 10 items, mean score range 1-5. Scores on the five items for the Positive Affect and Negative Affect subscales are averaged; with higher scores indicating greater negative affect and positive affect. This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up | |
Secondary | Self-esteem: Validated Hindi language version of the Rosenberg Self-Esteem Scale (Rosenberg, 1965) | Assessment of self-esteem using the Short-Form Rosenberg Self-Esteem scale, 10 items, mean score range 1-4. Scores are averaged, with higher scores indicating greater self-esteem. This measure is currently undergoing validation among Indian adolescents and in Hindi language. | Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up |
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