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Clinical Trials/NCT04317755
NCT04317755CompletedNot Applicable

A Randomised Control Trial Evaluating a Comic-based School Intervention to Promote Body Confidence and Related Outcomes Among Adolescents in India

University of the West of England1 site in 1 country2,631 target enrollmentStarted: March 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,631
Locations
1
Primary Endpoint
Body esteem: Validated Hindi language version of the Body Esteem Scale for adolescents & adults: Appearance and Weight subscales (Mendelson, Mendelson & White, 2001).

Study Overview

Brief Summary

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.

Detailed Description

Background:

Body image is a significant and prevalent concern for adolescents in high-income countries such as the UK, the USA, and Australia. For example, a national survey of nearly 22,000 young people in Australia found that 3 in 10 adolescent boys and girls are concerned about their appearance. This high prevalence of body image concerns is worrisome, given their serious negative physical and psychological health consequences, including unhealthy weight loss behaviours, eating disorders, depression and self-harm, substance use, and lower levels of academic engagement.

There is increasing recognition that body dissatisfaction is a global issue. For example, in India, 57% of adolescents report being concerned with their appearance. Further, girls across different regions of India have expressed concerns in relation to their weight and report dieting behaviours. Skin colour has also been indicated as an additional source of appearance concern among young people in India. Indeed, research indicated that 19% of Indian undergraduate students had used a skin lightening product in the previous 12 months, strongly suggesting dissatisfaction with their natural skin tone, which may be pertinent to younger groups.

Collectively, these findings indicate the importance of developing and disseminating interventions to promote positive body image among adolescents in India. The investigators recently finished developing and evaluating a school-based body image programme, 'Dove Confident Me', among adolescents in New Delhi, India. Immediate and 3-month follow-up improvements were found 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, where there is limited electricity and computers.

Therefore, the aim of the present study is to conduct an acceptability study followed by a randomised controlled trial of a comic-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-book-based programme will be based on 'Dove Confident Me'.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Masking not possible for participants within design, but investigators and outcome assessors will not know what condition participants are assigned to.

Eligibility Criteria

Ages
11 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

Control

No Intervention

Schools lessons as usual

Intervention

Experimental

Comic-based body image programme

Intervention: AdhaFULL body image comics (Behavioral)

Outcomes

Primary Outcomes

Body esteem: Validated Hindi language version of the Body Esteem Scale for adolescents & adults: Appearance and Weight subscales (Mendelson, Mendelson & White, 2001).

Time Frame: Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up

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.

Secondary Outcomes

  • Self-esteem: Validated Hindi language version of the Rosenberg Self-Esteem Scale (Rosenberg, 1965)(Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up)
  • 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)(Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up)
  • Life disengagement due to body image concerns: Validated Hindi language version of the Body Image Life Disengagement Questionnaire (Atkinson & Diedrichs, 2021)(Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up)
  • Eating pathology: Validated Hindi language version of the Eating Disorder Examination Questionnaire (Fairburn & Wilson, 1993)(Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up)
  • Mood: Validated Hindi language version of the Positive and Negative Affect Scale - Children (Laurent et al., 1999)(Baseline, post-intervention (4-weeks post baseline), 12-weeks follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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