Cluster Randomised Control Trial of the BodyKind Body Image Programme

NCT06076993 | Unknown Phase 1

• 1 other identifier: UCDublin1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Body dissatisfaction, a primary risk factor for eating disorders, is prevalent among adolescents. Given increases in adolescent body dissatisfaction since the Covid-19 pandemic, there is a pressing need for universal body image interventions, particularly for older adolescents aged 15-17 years, as this is a peak time for the onset of adolescent body image concerns; however, currently there are no evidence-based body image programmes for this age group. This cluster randomised control trial will evaluate the effectiveness of BodyKind, a four session, teacher led, mixed gender body image intervention for older adolescents that incorporates empirically supported principles of self-compassion, cognitive dissonance and social justice. The version of BodyKind culturally adapted for the Irish context will be evaluated in adolescents aged 15-17 years in fourth year in post-primary schools in Ireland. Primary outcomes of body dissatisfaction, body appreciation and psychological wellbeing, in addition to secondary outcomes of body ideal internalisation, self-compassion and compassion for others will be assessed at pre, post and 2 month follow up in intervention groups (who receive the BodyKind programme) and waitlist controls.

Conditions

Body Image

Outcome Measures

Primary Outcomes (3)

• Body Appreciation

  Body Appreciation Scale-2 is a 10-item scale. Responses to items such "I feel good in my body" are indicated on a 5-point Likert Scale (1-5), with higher scores indicating higher levels of body appreciation (Min-Max: 10-50). BAS-2 demonstrates good validity and reliability among international adolescent samples

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

• Body Dissatisfaction

  Body Satisfaction Visual Analogue Scales Items from the appearance/weight subscales of the Eating Disorder Examination Questionnaire will be adapted as 10-point visual analogue scales (VAS) to assess state body satisfaction with various aspects of appearance. Participants will use a 10-point slider 0 (not at all satisfied) and 10 (very satisfied) to rate how satisfied they feel with their body shape, weight, and size. Participants will also rate their satisfaction with height, muscle mass/tone and overall appearance. A mean score from the six appearance dimensions will be calculated, with higher scores representing higher state body satisfaction. This approach has been shown to have good convergent validity with the Eating Disorder Inventory Body Dissatisfaction Subscale in adolescents (r = .62). Higher scores indicate higher body satisfaction. (Min-Max score: 6-60\]

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

• Psychological wellbeing

  The Five-Item World Health Organisation Wellbeing Index is a unidimensional scale that measures emotional wellbeing using five positively worded items. Participants indicate the extent to which positive feelings, such as "I have felt calm and relaxed" were experienced over the last two weeks, using 6-point Likert scales ranging from 0 (not present) to 5 (constantly present). Raw scores are transformed to a score from 0 (worst thinkable well-being) to 100 (best thinkable well-being) with scores \<50 suggesting poor emotional well-being.The WHO-5 has been validated for use with adolescents and has adequate validity as an outcome measure in clinical trials

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

Secondary Outcomes (4)

• Self-compassion

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

• Body ideal internalization

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

• Appearance related social media use

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

• Compassion towards others

  1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up

Other Outcomes (1)

• Teacher fidelity

  1 week post intervention

Study Arms (2)

BodyKind programme group

EXPERIMENTAL

The intervention group will receive the BodyKind body image programme. The four 50 minute lessons of the BodyKind programme will be delivered by teachers at a rate of 1 lesson per week over four consecutive weeks.

Behavioral: BodyKind programme

Waitlist control

NO INTERVENTION

The waitlist control group will engage in classes as usual and will receive the BodyKind programme after data is collected.

Interventions

BodyKind programme BEHAVIORAL

BodyKind is a four-session, teacher-led, school-based programme for adolescents aged 15-17 years. This programme was developed by a team of international experts in body image and incorporates empirically supported principles of cognitive dissonance (which involves publicly criticising body ideals) and self-compassion (which involves reappraising self-critical evaluations). BodyKind also contains a social activism component that aims to tackle appearance biases, discrimination and racism and promote greater inclusivity and compassion for others. Programme Outline Lesson 1. Appearance Bias Lesson 2. Self-compassion \& social media Lesson 3. Compassion for others Lesson 4. Becoming agents of change Learning Objectives * To cultivate skills in awareness, mindfulness, non-judgement, reflection, conscientiousness, compassion * To decrease levels of body dissatisfaction and self-criticism * To improve levels of self-compassion, positive body image, psychological wellbeing

BodyKind programme group

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schools will be eligible if
• they are a second-level school in Ireland that offers the Transition Year (TY) programme to students
• will deliver the intervention as part of their curriculum to students in TY
• teaching staff are willing to complete the 2.5-hour BodyKind teacher training programme.
• Students will be eligible if
• they are in TY in a second-level school in Ireland and are aged 15-17 years
• If their parent consents to their participation AND if they provide a signed assent form .
• Teachers will be eligible if
• They are qualified secondary school teacher
• They agree to complete the BodyKind teacher training
• Return a signed informed consent form

You may not qualify if:

• Schools will be excluded if
• they are not a second-level school in Ireland or if they do not offer the TY programme to students
• will not deliver the intervention as part of their curriculum to students in TY
• teaching staff are not willing to complete the 2.5-hour BodyKind teacher training programme.
• Students will be excluded if
• they are not in TY in a second-level school and are not aged 15-17 years
• If parental consent has not been obtained OR if they fail to sign a participant assent .
• Teachers will be excluded if
• They are not qualified secondary school teacher
• They do not agree to complete the BodyKind teacher training
• Do not return a signed informed consent form

Sponsors & Collaborators

• University College Dublin: lead
• Jigsaw, The National Centre for Youth Mental Health, Ireland: collaborator
• Irish Research Council: collaborator
• Be Real USA NFP: collaborator

Study Sites (1)

University College Dublin

Dublin, Ireland

RECRUITING

Related Publications (14)

• Roy A, Bhaumik DK, Aryal S, Gibbons RD. Sample size determination for hierarchical longitudinal designs with differential attrition rates. Biometrics. 2007 Sep;63(3):699-707. doi: 10.1111/j.1541-0420.2007.00769.x.

  PMID: 17825003 BACKGROUND

• Blom-Hoffman J, Leff SS, Franko DL, Weinstein E, Beakley K, Power TJ. Consent Procedures and Participation Rates in School-Based Intervention and Prevention Research: Using a Multi-Component, Partnership-Based Approach to Recruit Participants. School Ment Health. 2009 Mar 1;1(1):3-15. doi: 10.1007/s12310-008-9000-7.

  PMID: 19834586 BACKGROUND

• Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.

  PMID: 25462882 BACKGROUND

• Durkin SJ, Paxton SJ. Predictors of vulnerability to reduced body image satisfaction and psychological wellbeing in response to exposure to idealized female media images in adolescent girls. J Psychosom Res. 2002 Nov;53(5):995-1005. doi: 10.1016/s0022-3999(02)00489-0.

  PMID: 12445589 BACKGROUND

• Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

  PMID: 25831962 BACKGROUND

• Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3.

  PMID: 32125190 BACKGROUND

• Thompson JK, van den Berg P, Roehrig M, Guarda AS, Heinberg LJ. The sociocultural attitudes towards appearance scale-3 (SATAQ-3): development and validation. Int J Eat Disord. 2004 Apr;35(3):293-304. doi: 10.1002/eat.10257.

  PMID: 15048945 BACKGROUND

• Gordon CS, Rodgers RF, Slater AE, McLean SA, Jarman HK, Paxton SJ. A cluster randomized controlled trial of the SoMe social media literacy body image and wellbeing program for adolescent boys and girls: Study protocol. Body Image. 2020 Jun;33:27-37. doi: 10.1016/j.bodyim.2020.02.003. Epub 2020 Feb 18.

  PMID: 32086189 BACKGROUND

• Choukas-Bradley S, Nesi J, Widman L, Galla BM. The Appearance-Related Social Media Consciousness Scale: Development and validation with adolescents. Body Image. 2020 Jun;33:164-174. doi: 10.1016/j.bodyim.2020.02.017. Epub 2020 Mar 17.

  PMID: 32193170 BACKGROUND

• Henje E, Rindestig FC, Gilbert P, Dennhag I. Psychometric validity of the Compassionate Engagement and Action Scale for Adolescents: a Swedish version. Scand J Child Adolesc Psychiatr Psychol. 2020 Jul 18;8:70-80. doi: 10.21307/sjcapp-2020-007. eCollection 2020.

  PMID: 33520779 BACKGROUND

• Walton H, Spector A, Tombor I, Michie S. Measures of fidelity of delivery of, and engagement with, complex, face-to-face health behaviour change interventions: A systematic review of measure quality. Br J Health Psychol. 2017 Nov;22(4):872-903. doi: 10.1111/bjhp.12260. Epub 2017 Aug 1.

  PMID: 28762607 BACKGROUND

• Gattario KH, Frisen A. From negative to positive body image: Men's and women's journeys from early adolescence to emerging adulthood. Body Image. 2019 Mar;28:53-65. doi: 10.1016/j.bodyim.2018.12.002. Epub 2018 Dec 21.

  PMID: 30583277 BACKGROUND

• Kurz M, Rosendahl J, Rodeck J, Muehleck J, Berger U. School-Based Interventions Improve Body Image and Media Literacy in Youth: A Systematic Review and Meta-Analysis. J Prev (2022). 2022 Feb;43(1):5-23. doi: 10.1007/s10935-021-00660-1. Epub 2021 Dec 28.

  PMID: 34962632 BACKGROUND

• Mahon C, Hamburger D, Webb JB, Yager Z, Howard E, Booth A, Fitzgerald A. Protocol of a cluster randomised trial of BodyKind: a school-based body image programme for adolescents. BMC Public Health. 2023 Nov 14;23(1):2246. doi: 10.1186/s12889-023-17002-x.

  PMID: 37964252 DERIVED

Study Officials

• Ciara Mahon, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciara Mahon, PhD

CONTACT

+353 1 716 8333; ciara.mahon@ucd.ie

Amanda Fitzgerald, PhD

CONTACT

+353 1 7168541; Amanda.fitzgerald@ucd.ie

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel two-arm cluster randomized controlled effectiveness trial. This pragmatic trial will be conducted in settings similar to the "real world" which will include use of a school setting, teacher-led delivery during classroom time, no strict exclusion criteria for students and comparison to routine lessons-as-usual.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 11, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)