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Evaluation of Two Eating Disorders Prevention Interventions in At-Risk Female Students With Body Dissatisfaction (HEIDI-BP-HW)

Primary Purpose

Body Dissatisfaction

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Body Project (BP)
Healthy Weight Program (HW)
Sponsored by
School of Health Sciences Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Dissatisfaction

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • School of Health Sciences (HES-SO Geneva)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Body Project (BP)

Healthy Weight Program (HW)

Waiting-list (WL)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
September 4, 2020
Last Updated
July 13, 2022
Sponsor
School of Health Sciences Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04558073
Brief Title
Evaluation of Two Eating Disorders Prevention Interventions in At-Risk Female Students With Body Dissatisfaction
Acronym
HEIDI-BP-HW
Official Title
Prevention of Eating Disorders in At-Risk Female Students: Adaptation and Evaluation of Two Interventions in French-Speaking Switzerland
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
School of Health Sciences Geneva

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dissatisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The participants and the collaborators performing the interventions will not be blinded to the conditions. In order to minimize bias, the main statistical analyses aimed at evaluating the hypotheses will be performed by a statistician blinded to the participants' allocation.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body Project (BP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Weight Program (HW)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting-list (WL)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body Project (BP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Weight Program (HW)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Mean change in Body Dissatisfaction after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Secondary Outcome Measure Information:
Title
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
Description
Mean change in thin-ideal internalization after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Title
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
Description
Mean change in Dietary Restraint after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Title
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
Description
Mean change in Anxiety after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Title
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
Description
Mean change in Depression after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Title
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
Description
Mean change in Eating Disorders Psychopathology after interventions in comparison with waiting-list
Time Frame
one month (Month 1)
Title
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
Description
Mean change in Body Dissatisfaction between post-intervention and follow-up
Time Frame
one month (Month 2)
Title
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
Description
Mean change in Thin-Ideal Internalization between post-intervention and follow-up
Time Frame
one month (Month 2)
Title
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
Description
Mean change in Dietary Restraint between post-intervention and follow-up
Time Frame
one month (Month 2)
Title
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
Description
Mean change in Anxiety between post-intervention and follow-up
Time Frame
one month (Month 2)
Title
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
Description
Mean change in Depression between post-intervention and follow-up
Time Frame
one month (Month 2)
Title
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
Description
Mean change in Eating Disorders Psychopathology between post-intervention and follow-up
Time Frame
one month (Month 2)
Other Pre-specified Outcome Measures:
Title
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
Description
Mean of satisfaction with BP and HW assessed with four Likert scales after interventions
Time Frame
Month 1 or Month 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Carrard, PhD
Organizational Affiliation
School of Health Sciences Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Sciences (HES-SO Geneva)
City
Genève
State/Province
Carouge
ZIP/Postal Code
1227
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Evaluation of Two Eating Disorders Prevention Interventions in At-Risk Female Students With Body Dissatisfaction

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