An interventional study of Body Project (BP) and Healthy Weight Program (HW) in Body Dissatisfaction, sponsored by School of Health Sciences Geneva. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by School of Health Sciences Geneva · Not applicable, Interventional, and Prevention
Eating disorders are psychopathologies with serious repercussions on the somatic, psychological and social level. Currently available treatments are unfortunately for now not fully efficient, therefore researchers have recommended to develop prevention initiatives. Until now, no study has been carried out in Switzerland to evaluate the efficacy of an intervention for the prevention of eating disorders.
The goal of the present study is to evaluate two eating disorders prevention intervention that have been largely validated in the US, called the Body Project (BP) and the Healthy Weight Program (HW). Both interventions target body dissatisfaction, which is a well-identified risk factor of eating disorders. They will be compared to a one-month waiting list. Because of the pandemic situation due to the Severe Acute Respiratory Syndrome coronavirus (COVID-19), both interventions will be delivered virtually via a collaborative platform. The sessions will be recorded to carry out a quality control.
To compare the BP and HW interventions to a waiting list, a three-arm randomized controlled study will be carried out, including female students from French-speaking Switzerland. Recruitment will include 90 participants. Participants will be randomly assigned to one of the three arms of the study. They will be evaluated before (T0) and after (T1) the interventions or the waiting list. Following the interventions, the participants will have one month of follow-up before a final evaluation (T2). Participants on the waiting list will receive the BP following the one-month waiting period and will then be evaluated (T2).
After having signed the consent form, the participant will be randomized to one of the three study arms, with a 1: 1: 1 allocation ratio. Interventions will be given in groups of six participants. Randomization will be blocked to ensure groups of equal size, and that groups of six participants for each arm are regularly formed. The blocks will be of variable size (3, 6, 9) to protect the concealment.
The hypotheses are as follows:
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
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Exclusion Criteria:
The BP intervention includes four one-hour sessions given over a month by two facilitators. The sessions will be held on a collaborative platform in groups of six people.
Behavioral: Body Project (BP)
The HW intervention includes four one-hour sessions given over a month by two facilitators. The sessions will be held on a collaborative platform in groups of six people.
Behavioral: Healthy Weight Program (HW)
The waiting list will consist of two assessments each separated by a one-month interval. Following this waiting time, participants will receive the BP intervention.
The BP intervention offers discussions and exercises to make participants realize the cost of pursuing social ideals valuing thinness. This produces "cognitive dissonance", a cognitive discomfort due to a contradiction between speech and beliefs, which motivates to modify one's beliefs. The curriculum includes discussions on techniques of the advertising industry and the unique ideal of beauty promoted worldwide, as well as on the costs of pursuing the thin-ideal. Participants are also challenged to try behaviours they avoid because their appearance bother them. Societal activism actions are also discussed.
The HW intervention allows participants to make personalized changes in their diet and physical activity each week gradually, to aim for a health-ideal rather than a thin-ideal. The intervention is based on small changes, based on behavioural change techniques. Advice is given on what types of changes introduce to promote health, and how to implement changes sustainably. Difficulties are discussed in the group with a problem-solving approach. The last session introduces a long-term view of lifestyle change.
Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from baseline to post-intervention or post-waiting
Mean change in Body Dissatisfaction after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from baseline to post-intervention or post-waiting
Mean change in thin-ideal internalization after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from baseline to post-intervention or post-waiting
Mean change in Dietary Restraint after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from baseline to post-intervention or post-waiting
Mean change in Anxiety after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from baseline to post-intervention or post-waiting
Mean change in Depression after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from baseline to post-intervention or post-waiting
Mean change in Eating Disorders Psychopathology after interventions in comparison with waiting-list
Time frame: one month (Month 1)
Mean Change in Body Dissatisfaction on the Body Shape Questionnaire 8C (score ranging from 8 to 48, with higher scores indicating higher body dissatisfaction) from post-intervention to follow-up
Mean change in Body Dissatisfaction between post-intervention and follow-up
Time frame: one month (Month 2)
Mean Change in Thin-Ideal Internalization on the Socio-Cultural Attitudes Towards Appearance Questionnaire (score ranging from 1 to 5 with higher scores indicating higher thin-ideal internalization) from post-intervention to follow-up
Mean change in Thin-Ideal Internalization between post-intervention and follow-up
Time frame: one month (Month 2)
Mean Change in Dietary Restraint on the Dutch Eating Behaviour Questionnaire (score ranging from 1 to 5 with higher scores indicating higher dietary restraint) from post-intervention to follow-up
Mean change in Dietary Restraint between post-intervention and follow-up
Time frame: one month (Month 2)
Mean Change in Anxiety on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher anxiety) from post-intervention to follow-up
Mean change in Anxiety between post-intervention and follow-up
Time frame: one month (Month 2)
Mean Change in Depression on the Hospital Anxiety and Depression Scale (score ranging from 0 to 21 with higher scores indicating higher depression) from post-intervention to follow-up
Mean change in Depression between post-intervention and follow-up
Time frame: one month (Month 2)
Mean Change in Eating Disorders Psychopathology on the Eating Disorders Examination-Questionnaire (score ranging from 0 to 6 with higher scores indicating higher eating disorders psychopathology) from post-intervention to follow-up
Mean change in Eating Disorders Psychopathology between post-intervention and follow-up
Time frame: one month (Month 2)
Mean of four 5-point Likert scales assessing program usefullness, help, understandability, usefulness of exercises (score from 1 to 5 with 5 indicating higher satisfaction) after interventions
Mean of satisfaction with BP and HW assessed with four Likert scales after interventions
Time frame: Month 1 or Month 2
Plan to share: Yes — At the end of the study, the data will be stored in a repository which guarantees archiving and data sharing in accordance with Findability, Accessibility, Interoperability, and Reuse of digital assets (FAIR) principles.
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