NCT04825184

Brief Summary

High prevalence of body and eating concerns in Brazilian populations is well-documented, with risk observed across the lifespan. Prevalence rates of body dissatisfaction range between 26.6 - 56% and 10.7- 36% for adolescent girls and boys, respectively (1, 2, 3). The prevalence of these disordered attitudes and behaviours are mirrored in older populations, and have shown to manifest within family units (6). Further, Brazilian consumer trends reflect these attitudes and behaviours, with it being the leading country in diet pill consumption and aesthetic surgeries, and second in the world for total aesthetic procedures (i.e., surgical and non-surgical), with 2.27 million procedures conducted annually (8). Despite the scope of body and eating concerns, few evidence-based interventions have been developed and tested for Brazilian populations and even fewer are accessible, scalable or cost-effective. Harnessing technology to deliver evidence-based care is a key focus for researchers. Micro-interventions (brief, low intensity, self-administered interventions), offer an alternative to traditional, intense interventions that may be unsuitable for milder concerns. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among women (9). To date, body image micro-interventions have been developed and evaluated among high-income, White, English-speaking samples, with little research exploring how this intervention model may cater to other cultures and countries. The aim of the present study is to conduct a randomised controlled trial (RCT) to evaluate the immediate and short-term impact of a chatbot on Brazilian adolescents' body image, affect and body image self-efficacy. Primary outcomes include immediate and short-term changes in state- and trait-based body image, respectively. Secondary outcomes include immediate changes in state-based affect and short-term changes in trait affect and body image self-efficacy. The chatbot intervention is designed to target sociocultural risk and protective factors for body image using eight, brief therapeutic techniques derived from several evidence-based theories, including media literacy, cognitive behaviour theory and positive body image. The chatbot was developed through a collaboration between Dove (Unilever), United Nations Children's Fund (UNICEF), The Centre for Appearance Research, and Talk 2 U. The comparison control condition will be assessment only. This is informed by a care as usual framework; whereby, Brazilian adolescents are not currently offered body image prevention or intervention resources at school or within the community. To undertake this project, 2800 adolescent girls and boys will be recruited through an external research agency. Participants will be randomised to either the chatbot or assessment only conditions. Those in the intervention condition, will be encouraged to engage with the chatbot over a 72-hour period, where they will be assessed on state-body satisfaction and affect immediately before and after completing an intervention technique. All participants will be assessed on trait body image, affect and body image self-efficacy at baseline, post-intervention (72-hours) and at one-week and one-month follow-ups. At completion of the one-month follow-up, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body and eating concerns. Those in the assessment only condition will be invited to engage with the chatbot; however, their engagement will not be monitored or assessed. Lastly, to compensate participants for their time, they will receive an electronic voucher to the value of approx. US$25 and US$21, for the intervention and control condition, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,715

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

November 18, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2021

Completed
Last Updated

February 3, 2022

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

November 18, 2020

Last Update Submit

February 2, 2022

Conditions

Keywords

Body imageAdolescentsBrazilPreventionMicro-intervention

Outcome Measures

Primary Outcomes (2)

  • Change in state body satisfaction

    Measured via a 11-point Likert scale (0 = not at all satisfied; 10 = very satisfied).

    Immediately pre-intervention and immediately post-intervention (change)

  • Change in trait body image

    Brazilian version of the Body Esteem Scale for Adolescents and Adults (BESAA; 13); a 23-item scale, comprising of three subscales: appearance esteem, weight esteem and attribution. Responses are scored on a 5-point Likert scale (1 = never to 5 = always).

    Baseline, post-intervention (72-hours following baseline assessment), one-week follow-up (7-days following post-intervention assessment) and one-month follow-up (28-days following post-intervention assessment).

Secondary Outcomes (5)

  • Change in state affect

    Immediately pre-intervention and immediately post-intervention (change)

  • Change in trait affect

    Baseline, post-intervention (72-hours following baseline assessment), one-week follow-up (7-days following post-intervention assessment) and one-month follow-up (28-days following post-intervention assessment).

  • Change in body image self-efficacy

    Baseline, post-intervention (72-hours following baseline assessment), one-week follow-up (7-days following post-intervention assessment) and one-month follow-up (28-days following post-intervention assessment).

  • Total acceptability of the intervention

    Through intervention completion, over the course of 72-hours.]

  • Total intervention adherence

    Through intervention completion, over the course of 72-hours.

Study Arms (2)

Body image chatbot

EXPERIMENTAL

The artificial intelligence chatbot, Topity, is designed to target sociocultural risk and protective factors for body image using eight therapeutic techniques derived from several evidence-based theories, including media literacy, cognitive behaviour theory and positive body image. The intervention aims to engage users in techniques that teaches users how to 1) Critically analyse and evaluate media content to reduce vulnerability to negative media influences (i.e., media literacy theory; 10); 2) Identify and challenge unhelpful thinking styles and behaviours that perpetuate body image distress (i.e., cognitive behaviour theory; 11); and 3) Appreciating the features, functions and health of the body, beyond it's appearance (i.e., positive body image theory; 12). Users will be assessed on state body satisfaction and affect before and after engaging with a technique to assess the immediate impact of the micro-intervention.

Behavioral: Body image chatbot

Assessment only

NO INTERVENTION

The comparison control condition will be assessment only. This is informed by a care as usual framework; whereby, Brazilian adolescents are not currently offered online body image prevention or intervention resources at school or within the community.

Interventions

See arm/group description.

Also known as: Topity
Body image chatbot

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Those aged 13-18 years old; Portuguese speaking; Brazilian resident; and, have access to Facebook Messenger.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toluna

São Paulo, Brazil

Location

Related Publications (19)

  • Amaral ACS, Stice E, Ferreira MEC. A controlled trial of a dissonance-based eating disorders prevention program with Brazilian girls. Psicol Reflex Crit. 2019 Jun 17;32(1):13. doi: 10.1186/s41155-019-0126-3.

    PMID: 32026167BACKGROUND
  • Moehlecke M, Blume CA, Cureau FV, Kieling C, Schaan BD. Self-perceived body image, dissatisfaction with body weight and nutritional status of Brazilian adolescents: a nationwide study. J Pediatr (Rio J). 2020 Jan-Feb;96(1):76-83. doi: 10.1016/j.jped.2018.07.006. Epub 2018 Aug 9.

    PMID: 30098939BACKGROUND
  • Santana ML, Silva Rde C, Assis AM, Raich RM, Machado ME, de J Pinto E, de Moraes LT, Ribeiro Junior Hda C. Factors associated with body image dissatisfaction among adolescents in public schools students in Salvador, Brazil. Nutr Hosp. 2013 May-Jun;28(3):747-55. doi: 10.3305/nh.2013.28.3.6281.

    PMID: 23848099BACKGROUND
  • Leal GVDS, Philippi ST, Alvarenga MDS. Unhealthy weight control behaviors, disordered eating, and body image dissatisfaction in adolescents from Sao Paulo, Brazil. Braz J Psychiatry. 2020;42(3):264-270. doi: 10.1590/1516-4446-2019-0437. Epub 2020 Jan 31.

    PMID: 32022158BACKGROUND
  • Silva SUD, Barufaldi LA, Andrade SSCA, Santos MAS, Claro RM. Nutritional status, body image, and their association with extreme weight control behaviors among Brazilian adolescents, National Adolescent Student Health Survey 2015. Rev Bras Epidemiol. 2018 Nov 29;21(suppl 1):e180011. doi: 10.1590/1980-549720180011.supl.1. English, Portuguese.

    PMID: 30517462BACKGROUND
  • Abdalla S, Buffarini R, Weber AM, Cislaghi B, Costa JC, Menezes AMB, Goncalves H, Wehrmeister FC, Meausoone V, Victora CG, Darmstadt GL. Parent-Related Normative Perceptions of Adolescents and Later Weight Control Behavior: Longitudinal Analysis of Cohort Data From Brazil. J Adolesc Health. 2020 Jan;66(1S):S9-S16. doi: 10.1016/j.jadohealth.2019.09.007.

    PMID: 31866039BACKGROUND
  • Trindade AP, Appolinario JC, Mattos P, Treasure J, Nazar BP. Eating disorder symptoms in Brazilian university students: a systematic review and meta-analysis. Braz J Psychiatry. 2019 Mar-Apr;41(2):179-187. doi: 10.1590/1516-4446-2018-0014. Epub 2018 Oct 11.

    PMID: 30328965BACKGROUND
  • International Association for Aesthetic/Cosmetic Surgery. (2017). ISAPS International Survey on Aesthetic/Cosmetic Procedures Performed in 2017. ISAPS. https://www.isaps.org/wpcontent/uploads/2019/03/ISAPS_2017_International_Study_Cosmetic_Procedures_NEW.pdf

    BACKGROUND
  • Fuller-Tyszkiewicz, M., Richardson, B., Lewis, V., Linardon, J., Mills, J., Juknaitis, K., ... & Ware, A. (2019). A randomized trial exploring mindfulness and gratitude exercises as eHealth-based micro-interventions for improving body satisfaction. Computers in Human Behavior, 95, 58-65.

    BACKGROUND
  • Aufderheide, P. (1993). Media Literacy. A Report of the National Leadership Conference on Media Literacy. Aspen Institute, Communications and Society Program, 1755 Massachusetts Avenue, NW, Suite 501, Washington, DC 20036.7

    BACKGROUND
  • Cash, T. F. (2002). Body image: Cognitive behavioral perspectives on body image. Body images: A handbook of theory, research, and clinical practice, 38-46.

    BACKGROUND
  • Menzel, J. E., & Levine, M. P. (2011). Embodying experiences and the promotion of positive body image: The example of competitive athletics.

    BACKGROUND
  • Mendelson BK, Mendelson MJ, White DR. Body-esteem scale for adolescents and adults. J Pers Assess. 2001 Feb;76(1):90-106. doi: 10.1207/S15327752JPA7601_6.

    PMID: 11206302BACKGROUND
  • Damásio, B. F., Pacico, J. C., Poletto, M., & Koller, S. H. (2013). Refinement and psychometric properties of the eight-item Brazilian positive and negative affective schedule for children (PANAS-C8). Journal of Happiness Studies, 14(4), 1363-1378.

    BACKGROUND
  • Bandura, A. (1982). Self-efficacy mechanism in human agency. American psychologist, 37(2), 122.

    BACKGROUND
  • McCusker J, Lambert SD, Cole MG, Ciampi A, Strumpf E, Freeman EE, Belzile E. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention. Health Educ Behav. 2016 Dec;43(6):716-725. doi: 10.1177/1090198116637601. Epub 2016 May 13.

    PMID: 27179288BACKGROUND
  • Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care. 1998 Oct;21(10):1644-51. doi: 10.2337/diacare.21.10.1644.

    PMID: 9773724BACKGROUND
  • Matheson EL, Smith HG, Amaral ACS, Meireles JFF, Almeida MC, Linardon J, Fuller-Tyszkiewicz M, Diedrichs PC. Using Chatbot Technology to Improve Brazilian Adolescents' Body Image and Mental Health at Scale: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Jun 19;11:e39934. doi: 10.2196/39934.

  • Matheson EL, Smith HG, Amaral ACS, Meireles JFF, Almeida MC, Mora G, Leon C, Gertner G, Ferrario N, Suarez Battan L, Linardon J, Fuller-Tyszkiewicz M, Diedrichs PC. Improving body image at scale among Brazilian adolescents: study protocol for the co-creation and randomised trial evaluation of a chatbot intervention. BMC Public Health. 2021 Nov 20;21(1):2135. doi: 10.1186/s12889-021-12129-1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysts will be blinded to condition allocation (dummy coded) when conducting statistical analyses on primary and secondary trait outcomes; however, blind analyses cannot be conducted on primary and secondary state measures due to the within-group design. Two datasets will be created one for between group analyses with dummy coding, and a second dataset for within group analyses without dummy coding.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

April 1, 2021

Study Start

April 6, 2021

Primary Completion

August 8, 2021

Study Completion

August 8, 2021

Last Updated

February 3, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations