NCT04558073: HEIDI-BP-HW

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

Completed NA Last updated 27 November 2023

What this trial tests

NA trial testing Body Project (BP) in Body Dissatisfaction in 40 participants. Completed in 12 July 2022.

Timeline

1 January 2021

Primary endpoint
30 May 2022

12 July 2022

Quick facts

Lead sponsor	School of Health Sciences Geneva
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	1 January 2021
Primary completion	30 May 2022
Estimated completion	12 July 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Body Project (BP)
• Healthy Weight Program (HW)

Conditions studied

• Body Dissatisfaction — all drugs for Body Dissatisfaction →

Sponsor

School of Health Sciences Geneva

Who can join

Adults 18 to 25, female only, with Body Dissatisfaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. 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;
2. There will be no differences between the BP and the HW on the primary and secondary outcomes;
3. The effects observed thanks to the interventions will be maintained after one month of follow-up.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized controlled trial to evaluate the acceptability and effectiveness of two eating disorders prevention interventions: the HEIDI BP-HW project.
   Carrard I, Cekic S, Bucher Della Torre S. · · 2023 · cited 2× · PMID 37612687 · DOI 10.1186/s12905-023-02607-6
2. A study protocol for a preliminary randomised controlled trial assessing the acceptability and effectiveness of two eating disorders prevention interventions in Switzerland: The HEIDI BP-HW project.
   Carrard I, Bucher Della Torre S. · · 2021 · cited 1× · PMID 34780528 · DOI 10.1371/journal.pone.0259796