Prevention of Eating Disorders Through Optimization of Protective Factors

Eating Disorders Clinical Trial

Official title:

A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863598
• Other study ID #: 2022-01039
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: Karolinska Institutet
• Contact: Ata Ghaderi, PhD
• Phone: +46 8 524 832 48
• Email: ata.ghaderi[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder.

The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).

Description:

Research area and aims:

Eating disorders (EDs) are common and cause significant morbidity and mortality. Due to stigma, only 25% seek help and only 50% fully recover after receiving treatments. Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level. However, current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation. The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable, brief, and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design. A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization.

Research questions:

1. How effective is an internet-based prevention program, that reinforces protective factors against EDs, in reducing the onset of EDs 6, 12, 24, and 36 months post-intervention?

2. Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)?

3. Is prevention of EDs based on reinforcement of protective factors cost-effective?

4. How do the participant experience their participation in these two interventions?

Other research questions concern gender differences in enrollment and compliance, potential moderators of outcome, participation in booster sessions, and potential risk for stigma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 644
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

Inclusion Criteria: Youth and young people (15-20 years) with a subjective experience of body dissatisfaction.

Exclusion Criteria: Indications of depression, or suicidality, as well as presence of an eating disorder, or other conditions that may require medical attention, or conditions that makes it impossible to complete the intervention (e.g., not being able to read and write in Swedish).

Related Conditions & MeSH terms

• Body Dissatisfaction
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Enhancing protective factors
Participants will watch some short movies and infographics, and will be asked to argue for the importance of body image flexibility, body functionality appreciation, etc.
• Expressive writing
Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

Ahlen J, Hursti T, Tanner L, Tokay Z, Ghaderi A. Prevention of Anxiety and Depression in Swedish School Children: a Cluster-Randomized Effectiveness Study. Prev Sci. 2018 Feb;19(2):147-158. doi: 10.1007/s11121-017-0821-1. — View Citation

Andrew R, Tiggemann M, Clark L. The protective role of body appreciation against media-induced body dissatisfaction. Body Image. 2015 Sep;15:98-104. doi: 10.1016/j.bodyim.2015.07.005. Epub 2015 Aug 24. — View Citation

Atkinson MJ, Wade TD. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study. Int J Eat Disord. 2015 Nov;48(7):1024-37. doi: 10.1002/eat.22416. Epub 2015 Jun 6. — View Citation

Burychka D, Miragall M, Banos RM. Towards a Comprehensive Understanding of Body Image: Integrating Positive Body Image, Embodiment and Self-Compassion. Psychol Belg. 2021 Jul 27;61(1):248-261. doi: 10.5334/pb.1057. eCollection 2021. — View Citation

Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506. — View Citation

Homan KJ, Tylka TL. Self-compassion moderates body comparison and appearance self-worth's inverse relationships with body appreciation. Body Image. 2015 Sep;15:1-7. doi: 10.1016/j.bodyim.2015.04.007. Epub 2015 May 16. — View Citation

Koller KA, Thompson KA, Miller AJ, Walsh EC, Bardone-Cone AM. Body appreciation and intuitive eating in eating disorder recovery. Int J Eat Disord. 2020 Aug;53(8):1261-1269. doi: 10.1002/eat.23238. Epub 2020 Feb 5. — View Citation

Levine MP, Smolak L. The role of protective factors in the prevention of negative body image and disordered eating. Eat Disord. 2016;24(1):39-46. doi: 10.1080/10640266.2015.1113826. Epub 2015 Dec 7. No abstract available. — View Citation

Linardon J, Tylka TL, Fuller-Tyszkiewicz M. Intuitive eating and its psychological correlates: A meta-analysis. Int J Eat Disord. 2021 Jul;54(7):1073-1098. doi: 10.1002/eat.23509. Epub 2021 Mar 30. — View Citation

Mensinger JL, Granche JL, Cox SA, Henretty JR. Sexual and gender minority individuals report higher rates of abuse and more severe eating disorder symptoms than cisgender heterosexual individuals at admission to eating disorder treatment. Int J Eat Disord. 2020 Apr;53(4):541-554. doi: 10.1002/eat.23257. Epub 2020 Mar 13. — View Citation

Moffitt RL, Neumann DL, Williamson SP. Comparing the efficacy of a brief self-esteem and self-compassion intervention for state body dissatisfaction and self-improvement motivation. Body Image. 2018 Dec;27:67-76. doi: 10.1016/j.bodyim.2018.08.008. Epub 2018 Aug 23. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderators of outcomes: Sex, Age, Socio-economic status.	Data on sex (Male or Female), age (15-20) and socioeconomic status (level of education) will be used to investigate whether they moderated the rate of enrollment, compliance (how many modules of the program they complete), and outcome.	Baseline assessment
Other	Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect	Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study	Post-intervention (i.e., 5 weeks after the start of intervention)
Other	Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.	Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.	6-months post-intervention
Other	Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.	Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.	12-months post-intervention
Other	Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.	Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.	24-months post-intervention
Other	Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.	Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.	36-months post-intervention
Primary	Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).	The Eating disorders examination interview is the gold standard to establish diagnoses of eating disorders and will be used at baseline and to investigate the incidence of eating disorders (ED) during the follow-up period (36 months post intervention). Diagnostic status will be specified based on specific criteria for each ED diagnosis.	Baseline to 36 months post-intervention
Secondary	Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).	The Body Shape questionnaire (Brief version: 8 items) measures body dissatisfaction. It has good psychometric properties. Items are scored on a Likert-type scale from 1 (Never) to 6 (Always). Higher scores indicate more body dissatisfaction.	From baseline, up to 36 months post-intervention
Secondary	Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).	The Drive for Muscularity Scale (15 items) measures one of the risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 6. Higher scores indicate stronger drive for muscularity.	From baseline, up to 36 months post-intervention
Secondary	Change in the internalization of thin ideal through the Ideal Body Stereotype Scale-Revised (IBSS-R: Stice et al, 2008, J Consult Clin Pschol, 76, 329-340)	The Body Stereotype Scale-Revised (6 items) measures the internalization of the current thinness ideal, which is a risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate more internalization of the thin ideal.	From baseline, up to 36 months post-intervention
Secondary	Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).	The Brunnsviken Quality of Life Scale is a brief instrument (12 items) developed in Sweden with good psychometrics to measure quality of life. The items are rated on a scale from 0 to 4. Higher scores indicate stronger satisfaction with life.	From baseline, up to 36 months post-intervention
Secondary	Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).	The Body Appreciation Scale (10 items) has good psychometrics. The items are scored on a scale from 1 to 5. Higher scores indicate more body appreciation.	From baseline, up to 36 months post-intervention
Secondary	Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).	The Functionality Appreciation Scale (7 items) has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate higher appreciation of body functionality.	From baseline, up to 36 months post-intervention
Secondary	Change in body image flexibility through the Body Image Acceptance and Action Questionnaire (BI-AAQ-5: Sandoz et al, 2013, J Cont Behav Science, 2, 39-48).	The Body Image Acceptance and Action Questionnaire measures body image flexibility (5 items), which is another protective factor. Items are rated on a scale from 1 to 7. Higher scores indicate more body image flexibility.	From baseline, up to 36 months post-intervention
Secondary	Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).	The Intuitive Eating Scale (23 items) is an established measure of intuitive eating. It has good psychometric properties. Items are rated on a scale from 1 to 5. Higher scores indicate more intuitive eating.	From baseline, up to 36 months post-intervention
Secondary	Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).	The Self-Compassion Scale (Brief version: 12 items) has good psychometrics. It provides information on an important protective factor. Items are rated on a scale from 1 to 5. Higher scores indicate higher self-compassion.	From baseline, up to 36 months post-intervention
Secondary	Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).	The Bull's-Eye Values Survey helps to ascertain what ares in life (i.e., personal values) seem important to each participant. It has been adapted by providing the instructions through a brief instructional video instead of lengthy text. The importance of life directions are rated on a scale from 0 to 7. Higher scores indicate more importance. The proximity to life values is rated on a scale from 1 to 7. Higher scores indicate more proximity, where 7 is the bull's eye.	From baseline, up to 36 months post-intervention