NCT04289272

Brief Summary

Body image is one of the leading concerns for young people. Such concerns can have serious health consequences, including unhealthy weight control and exercise behaviours, depression and self-harm, low self-esteem and substance abuse. Emerging approaches for improving body image are effective among adolescent girls and boys in the school setting. However, the vast majority of trials in this area are conducted in high-income westernised countries, despite body image concerns increasingly being recognised as a global concern. As such, it is important to develop and disseminate interventions to promote positive body image among adolescents in in low-to-middle income countries, too. 'Confident Me' has been found to be effective in improving body image and related outcomes among adolescent girls and boys in the UK up to 12-months later, and thus, could undergo adaptations for the Indian context. The aim of the present study is two-fold:

  • To conduct a small-scale acceptability study of a 'Confident Me', a body image intervention, among 11-13-year olds in New Delhi, India, to understand its acceptability, feasibility, and preliminary efficacy in a metropolitan area of India.
  • To refine 'Confident Me' based on the acceptability study, and to conduct a randomised controlled trial to evaluate its efficacy at improving body image and related outcomes among 11-13-year olds in New Delhi, India. The first aim will be fulfilled by recruiting two schools, of which one will be randomised to the intervention and the other to the control arm. We will compare the body image and well-being of students who take part in the programme to students in the control group. The investigators will also gather in-depth feedback from students, teachers and the interventionist via focus groups and interviews, in order to inform future improvement of the programme. The second aim will be fulfilled by randomising six schools to either the revised body image programme (3 schools) or the control arm (3 schools). Students will complete questionnaire assessments of body image and well-being before and after the 5-week programme period, and again 12 weeks later to assess longer-term benefits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration 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

Study Start

First participant enrolled

February 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

February 5, 2020

Last Update Submit

July 3, 2020

Conditions

Keywords

body imageschoolinterventionadolescenceself-esteem

Outcome Measures

Primary Outcomes (1)

  • Change in body esteem over time: Body Esteem Scale for adolescents & adults (Mendelson, Mendelson & White, 2001).

    Assessment of body esteem using Body Esteem Scale for adolescents \& adults,18 items, 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.

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

Secondary Outcomes (5)

  • Change in eating pathology over time: Eating Disorder Examination Questionnaire (Fairburn & Beglin, 2008)

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

  • Internalisation of appearance ideals: The Sociocultural Attitudes Towards Appearance scale-3 (SATAQ-3): General Subscale (Thompson, Van Den Berg, Roehrig, Guarda, & Heinberg, 2004).

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

  • Life engagement Scale (Atkinson & Diedrichs, Manuscript in Preparation)

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

  • Positive and Negative Affect: The Positive and Negative Affect Scale (Crawford & Henry, 2004)

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

  • Self-Esteem: The Self-Esteem Scale (Rosenberg, 1965)

    Baseline, post-intervention (6-weeks post baseline), 10-week follow-up

Study Arms (2)

Dove Confident Me

EXPERIMENTAL

Dove Confident Me body image intervention to be delivered to students 1 lesson per week for 5 weeks (5 x 45 minute lessons).

Behavioral: Dove Confident Me

Control

NO INTERVENTION

Students receive lessons-as-usual.

Interventions

Dove Confident Me is a school-based intervention co-created by researchers at La Trobe University (Australia), the Centre for Appearance Research UWE, teachers, students, and education experts, and the Dove Self-Esteem Project (the social mission for personal care brand Dove). The five-session intervention is aimed at adolescents aged between 11-13 years, and targets recognised risk factors for body dissatisfaction, by addressing societal appearance ideals (Session 1), media literacy (Session 2), appearance comparisons (Session 3), appearance-related conversations and teasing (Session 4), and promoting 'body activism' (Session 5). The intervention consists of classroom-based discussion and small group activities, and uses audio-visual materials and worksheets to facilitate learning.

Dove Confident Me

Eligibility Criteria

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

You may qualify if:

  • Co-educational secondary schools in New Delhi
  • Middle income schools or private schools
  • have sufficient proficiency in speaking, reading and writing in Hinglish

You may not qualify if:

  • single-sex schools
  • low-income schools
  • do not have sufficient proficiency in speaking, reading or writing in Hinglish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the West of England

Bristol, Avon, BS161QY, United Kingdom

Location

Related Publications (13)

  • Al Sabbah H, Vereecken CA, Elgar FJ, Nansel T, Aasvee K, Abdeen Z, Ojala K, Ahluwalia N, Maes L. Body weight dissatisfaction and communication with parents among adolescents in 24 countries: international cross-sectional survey. BMC Public Health. 2009 Feb 6;9:52. doi: 10.1186/1471-2458-9-52.

    PMID: 19200369BACKGROUND
  • Fay K, Lerner RM. Weighing in on the issue: a longitudinal analysis of the influence of selected individual factors and the sports context on the developmental trajectories of eating pathology among adolescents. J Youth Adolesc. 2013 Jan;42(1):33-51. doi: 10.1007/s10964-012-9844-x. Epub 2012 Oct 31.

    PMID: 23111843BACKGROUND
  • Wichstrom L, von Soest T. Reciprocal relations between body satisfaction and self-esteem: A large 13-year prospective study of adolescents. J Adolesc. 2016 Feb;47:16-27. doi: 10.1016/j.adolescence.2015.12.003. Epub 2015 Dec 20.

    PMID: 26713411BACKGROUND
  • Neumark-Sztainer D, Paxton SJ, Hannan PJ, Haines J, Story M. Does body satisfaction matter? Five-year longitudinal associations between body satisfaction and health behaviors in adolescent females and males. J Adolesc Health. 2006 Aug;39(2):244-51. doi: 10.1016/j.jadohealth.2005.12.001.

    PMID: 16857537BACKGROUND
  • Yager Z, Diedrichs PC, Ricciardelli LA, Halliwell E. What works in secondary schools? A systematic review of classroom-based body image programs. Body Image. 2013 Jun;10(3):271-81. doi: 10.1016/j.bodyim.2013.04.001. Epub 2013 May 14.

    PMID: 23683611BACKGROUND
  • Muehlenkamp JJ, Brausch AM. Body image as a mediator of non-suicidal self-injury in adolescents. J Adolesc. 2012 Feb;35(1):1-9. doi: 10.1016/j.adolescence.2011.06.010. Epub 2011 Jul 20.

    PMID: 21777971BACKGROUND
  • Singh MM, Ashok L, Binu VS, Parsekar SS, Bhumika TV. Adolescents and Body Image: A Cross Sectional Study. Indian J Pediatr. 2015 Dec;82(12):1107-11. doi: 10.1007/s12098-015-1768-5. Epub 2015 May 8.

    PMID: 25947266BACKGROUND
  • Som N, Mishra SK, Mukhopadhyay S. Weight concerns and food habits of adolescent girls in two contrasting ecological regions: A comparative study in India. Eat Behav. 2016 Jan;20:21-6. doi: 10.1016/j.eatbeh.2015.11.006. Epub 2015 Nov 12.

    PMID: 26599837BACKGROUND
  • Peltzer K, Pengpid S, James C. The globalization of whitening: prevalence of skin lighteners (or bleachers) use and its social correlates among university students in 26 countries. Int J Dermatol. 2016 Feb;55(2):165-72. doi: 10.1111/ijd.12860. Epub 2015 Oct 15.

    PMID: 26472662BACKGROUND
  • 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.

    PMID: 33243723BACKGROUND
  • Schrick, B. H., Sharp, E. A., Zvonkovic, A., & Reifman, A. (2012). Never let them see you sweat: Silencing and striving to appear perfect among US college women. Sex Roles, 67(11-12), 591-604.

    BACKGROUND
  • Ramseyer Winter, V., Kennedy, A. K., & O'Neill, E. (2017). Adolescent Tobacco and Alcohol Use: The Influence of Body Image. Journal of Child & Adolescent Substance Abuse, 26(3), 219-228.

    BACKGROUND
  • Dhillon, M., & Deepak, S. (2017). A body-image based media literacy intervention for Indian adolescent females. Journal of Indian Association for Child & Adolescent Mental Health, 13(1).

    BACKGROUND

Related Links

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
masking not possible for participants within design, but outcome assessors do not know which condition participants are in
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

February 28, 2020

Study Start

February 1, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations