Body DissatisfactionHEIDI-BP-HWNCT04558073
Evaluation of Two Eating Disorders Prevention Interventions in At-Risk Female Students With Body Dissatisfaction
A study testing Body Project (BP) and Healthy Weight Program (HW) in people with Body Dissatisfaction, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Dissatisfaction
- What is being tested?
- Body Project (BP) and Healthy Weight Program (HW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female student;
- Aged between 18 and 25 years old;
- BMI between 18.5 and 30 kg/m2;
- French-speaking (or understand French sufficiently to participate in the intervention) and having lived in Switzerland for at least six months;
- Suffering from body dissatisfaction and obtain a score of at least 26 on the Body Shape Questionnaire 8-item (BSQ-8C) which represents a moderate concern with her body image;
- Accepting the use of a collaborative platform to participate in the intervention group, which implies that her name may be revealed, and accept that the sessions be recorded.
Who cannot join
- Eating disorder according to the Diagnostic and Statistical Manuel of Mental Disorders 5th edition (DSM-5) diagnostic criteria (past or current);
- Diagnosis of mood disorder or anxiety disorder;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
School of Health Sciences (HES-SO Geneva)
Geneva, Carouge, 1227
About this study
Official title: Prevention of Eating Disorders in At-Risk Female Students: Adaptation and Evaluation of Two Interventions in French-Speaking Switzerland
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.
Read more
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:
- The two interventions BP and HW will have an effect on body dissatisfaction (primary outcome) as well as on the thin-ideal internalization, dietary restraint, negative affect, and eating disorders psychopathology (secondary outcomes), compared to the waiting list;
- There will be no differences between the BP and the HW on the primary and secondary outcomes;
- The effects observed thanks to the interventions will be maintained after one month of follow-up.
- Conditions
- Body Dissatisfaction
- Being tested
- Body Project (BP), Healthy Weight Program (HW)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Project (BP)Behavioural
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.
Healthy Weight Program (HW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Project (BP) | Experimental | 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. Receives: Behavioral: Body Project (BP) |
| Healthy Weight Program (HW) | Experimental | 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. Receives: Behavioral: Healthy Weight Program (HW) |
| Waiting-list (WL) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month (Month 1)
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one month (Month 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jan 2021
- Primary completion30 May 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body DissatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Carrard, PhD, Principal investigator, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558073
- Sponsor's protocol ID
- 99021
- Acronym
- HEIDI-BP-HW
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Carrard I, Cekic S, Bucher Della Torre S. A randomized controlled trial to evaluate the acceptability and effectiveness of two eating disorders prevention interventions: the HEIDI BP-HW project. BMC Womens Health. 2023 Aug 23;23(1):446. doi: 10.1186/s12905-023-02607-6.
PubMed 37612687
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Eating Disorders in At-Risk Female Students: Adaptation and Evaluation of Two Interventions in French-Speaking Switzerland
- ClinicalTrials.gov ID
- NCT04558073
- Acronym / sponsor ID
- HEIDI-BP-HW / 99021
- Conditions
- Body Dissatisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The two interventions BP and HW will have an effect on body dissatisfaction (primary outcome) as well as on the thin-ideal internalization, dietary restraint, negative affect, and eating disorders psychopathology (secondary outcomes), compared to the waiting list;
- There will be no differences between the BP and the HW on the primary and secondary outcomes;
- The effects observed thanks to the interventions will be maintained after one month of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Body Project (BP) | Experimental | Behavioral: Body Project (BP)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. |
| Healthy Weight Program (HW) | Experimental | Behavioral: Healthy Weight Program (HW)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. |
| Waiting-list (WL) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female student;
- Aged between 18 and 25 years old;
- BMI between 18.5 and 30 kg/m2;
- French-speaking (or understand French sufficiently to participate in the intervention) and having lived in Switzerland for at least six months;
- Suffering from body dissatisfaction and obtain a score of at least 26 on the Body Shape Questionnaire 8-item (BSQ-8C) which represents a moderate concern with her body image;
Key exclusion criteria (3 listed)
- Eating disorder according to the Diagnostic and Statistical Manuel of Mental Disorders 5th edition (DSM-5) diagnostic criteria (past or current);
- Diagnosis of mood disorder or anxiety disorder;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Project (BP)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. | Behavioural | Body Project (BP) |
| Healthy Weight Program (HW)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. | Behavioural | Healthy Weight Program (HW) |
Primary outcome
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
Time frame: one month (Month 1)
Mean change in Body Dissatisfaction after interventions in comparison with waiting-list
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Time frame: one month (Month 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 37612687Carrard I, Cekic S, Bucher Della Torre S. A randomized controlled trial to evaluate the acceptability and effectiveness of two eating disorders prevention interventions: the HEIDI BP-HW project. BMC Womens Health. 2023 Aug 23;23(1):446. doi: 10.1186/s12905-023-02607-6.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Carrard, PhD principal investigator
School of Health Sciences Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Project (BP) and Healthy Weight Program (HW) in people with Body Dissatisfaction, run by School of Health Sciences Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: one month (Month 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.