NCT04317755

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,631

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 5, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

February 5, 2020

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

  • 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

  • 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

Other Outcomes (6)

  • Skin colour dissatisfaction: Purpose-built single-item measure developed for the study

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

  • Body hair dissatisfaction: Purpose-built single-item measure developed for the study.

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

  • Appearance-based teasing: Single-item measure adapted from a previous body image intervention evaluation (Diedrichs et al, 2012).

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

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Comic-based body image programme

Behavioral: AdhaFULL body image comics

Control

NO INTERVENTION

Schools lessons as usual

Interventions

The comics were co-created with the expertise of four stakeholders: the investigators, UNICEF, BBC Media Action, and the Dove Self-Esteem Project. There are six different comics, which target issues relating to gender stereotypes and appearance concerns amongst adolescents in rural India. Based on 'Dove Confident Me', each comic tells a story which targets a specific established risk factor for body dissatisfaction. Specifically, they focus on gender prejudice (Comic 1), societal appearance ideals (Comic 2), media literacy (Comic 3), appearance comparisons (Comic 4), appearance-related conversations and teasing (Comic 5), and promoting 'body activism' (Comic 6). In each session, students will read the respective comic as a class. At the end of each comic, the teacher will facilitate one or two activities with the students based on the key learnings from the comics. These activities will encourage students to think critically about what they have read and consolidate their learning.

Intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Single gender schools
  • Located in urban areas of Rajasthan
  • English medium
  • Does not include Classes 6-8 (students aged 11 to 14 years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Appearance Research, University of the West of England

Bristol, BS16 1QY, United Kingdom

Location

Related Publications (4)

  • 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: 10.1016/j.bodyim.2021.02.011. Epub 2021 Apr 1.

  • 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: 10.1016/j.jadohealth.2020.10.001. Epub 2020 Nov 24.

  • Lewis-Smith H, Ahuja L, Hasan F, Gentili C, White P, Diedrichs PC. A comic-based body image intervention for adolescents in semi-rural Indian schools: A randomised controlled trial. Int J Clin Health Psychol. 2025 Jan-Mar;25(1):100546. doi: 10.1016/j.ijchp.2025.100546. Epub 2025 Jan 26.

  • Ahuja L, Hasan F, Diedrichs PC, Lewis-Smith H. Comics as a body image intervention among adolescents in Indian Hindi medium schools: insights from an acceptability study. Glob Ment Health (Camb). 2022 Sep 29;9:460-469. doi: 10.1017/gmh.2022.50. eCollection 2022.

Study Officials

  • Phillippa C Diedrichs, PhD

    University of the West of England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking not possible for participants within design, but investigators and outcome assessors will not know what condition participants are assigned to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel 2-arm cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

March 23, 2020

Study Start

March 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations