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Prevention of Eating Disorders Through Optimization of Protective Factors

Primary Purpose

Body Dissatisfaction, Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhancing protective factors
Expressive writing
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Dissatisfaction focused on measuring eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Enhancing protective factors

    Expressive writing

    Arm Description

    Participants will learn to improve their body image through body appreciation tasks, body image flexibility and focus on body functionality appreciation. They also learn to focus on important life values, be more accepting of themselves, and learn to eat regularly and with attention to bodily needs and signals. This is don in interactive ways, and by using a cognitive dissonance frame.

    Participants will be instructed to write about any thoughts, feelings, images, memories, interceptions, ideas or emotions related to their body for the same during as the active intervention (i.e., 40 minutes/week across four consecutive weeks).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 17, 2023
    Sponsor
    Karolinska Institutet
    Collaborators
    Uppsala University, Linkoeping University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05863598
    Brief Title
    Prevention of Eating Disorders Through Optimization of Protective Factors
    Official Title
    A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2027 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Uppsala University, Linkoeping University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    Detailed 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: 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? Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)? Is prevention of EDs based on reinforcement of protective factors cost-effective? 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Dissatisfaction, Eating Disorders
    Keywords
    eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is randomized controlled trials. Participants will be randomized to the active prevention program, or to a placebo (expressive writing). The intervention is brief (four weeks only). Recruitment of the participants (n=644) will take one year (anticipated)After the intervention, they will receive a booster session and will be followed up every 6 months, for 36 months post-intervention.
    Masking
    Outcomes Assessor
    Masking Description
    Randomization will be conducted using a randomization list. As soon as a participant is eligible after providing baseline data and a clinical interview, the assessment staff will ask the coordinator to check what condition the participant should be assigned to based on the randomization list. The participants will be informed. At follow-ups, the assessors will not be aware of the intervention condition of each participants.
    Allocation
    Randomized
    Enrollment
    644 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhancing protective factors
    Arm Type
    Experimental
    Arm Description
    Participants will learn to improve their body image through body appreciation tasks, body image flexibility and focus on body functionality appreciation. They also learn to focus on important life values, be more accepting of themselves, and learn to eat regularly and with attention to bodily needs and signals. This is don in interactive ways, and by using a cognitive dissonance frame.
    Arm Title
    Expressive writing
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be instructed to write about any thoughts, feelings, images, memories, interceptions, ideas or emotions related to their body for the same during as the active intervention (i.e., 40 minutes/week across four consecutive weeks).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhancing protective factors
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expressive writing
    Intervention Description
    Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.
    Primary Outcome Measure Information:
    Title
    Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).
    Description
    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.
    Time Frame
    Baseline to 36 months post-intervention
    Secondary Outcome Measure Information:
    Title
    Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    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)
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    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).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Title
    Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).
    Description
    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.
    Time Frame
    From baseline, up to 36 months post-intervention
    Other Pre-specified Outcome Measures:
    Title
    Moderators of outcomes: Sex, Age, Socio-economic status.
    Description
    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.
    Time Frame
    Baseline assessment
    Title
    Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect
    Description
    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study
    Time Frame
    Post-intervention (i.e., 5 weeks after the start of intervention)
    Title
    Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
    Description
    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
    Time Frame
    6-months post-intervention
    Title
    Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
    Description
    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
    Time Frame
    12-months post-intervention
    Title
    Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
    Description
    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
    Time Frame
    24-months post-intervention
    Title
    Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
    Description
    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
    Time Frame
    36-months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ata Ghaderi, PhD
    Phone
    +46 8 524 832 48
    Email
    ata.ghaderi@ki.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Parling, PhD
    Phone
    +46 8 524 800 00
    Email
    thomas.parling@ki.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ata Ghaderi, PhD
    Organizational Affiliation
    PI employed at Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32551736
    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.
    Results Reference
    background
    PubMed Identifier
    26311661
    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.
    Results Reference
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    PubMed Identifier
    26052831
    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.
    Results Reference
    background
    PubMed Identifier
    34394951
    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.
    Results Reference
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    PubMed Identifier
    25978272
    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.
    Results Reference
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    PubMed Identifier
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    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.
    Results Reference
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    PubMed Identifier
    33786858
    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.
    Results Reference
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    PubMed Identifier
    32167198
    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.
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    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.
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    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.
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    Prevention of Eating Disorders Through Optimization of Protective Factors

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