HEIDI+ project: improving young women’s body image [Projet HEIDI+: améliorer l'image corporelle des jeunes femmes]

ISRCTN	ISRCTN10451254
DOI	https://doi.org/10.1186/ISRCTN10451254
Swiss National Clinical Trials Portal	SNCTP000006934
Sponsor	HES-SO University of Applied Sciences and Arts Western Switzerland
Funder	Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Submission date: 16/07/2026
Registration date: 17/07/2026
Last edited: 17/07/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Isabelle Carrard
Scientific, Principal investigator, Public

Filière Nutrition et diététique
Haute école de santé Genève (HES-SO)
Rue des Caroubiers 25
Carouge
1227
Switzerland

ORCID ID	0000-0002-2384-6696
Phone	+4122558 58 03
Email	isabelle.carrard@hesge.ch

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Prevention
Scientific title	HEIDI+: a pilot randomized controlled trial assessing feasibility, acceptability, and preliminary efficacy of a cognitive-dissonance intervention integrated with self-compassion elements in young women
Study acronym	HEIDI+
Study objectives	The intervention being evaluated is aimed at addressing body shame and body dissatisfaction, with the ultimate goal of preventing eating disorders. 1. The first objective of this pilot RCT has two distinct feasibility sub-objectives, each addressing a different question. 1.1. First, intervention feasibility concerns whether the new HEIDI+ intervention, which is an enhanced Body Project with self-compassion elements, can be delivered as designed and is acceptable to participants. 1.2. Second, trial feasibility concerns whether the evidence base and operational conditions justify proceeding to a definitive, adequately powered RCT. 2. A second objective concerns preliminary efficacy; consistent with best practice for pilot trials, this objective is estimation-focused and does not contribute to the go/no-go decision for a potential adequately powered RCT.
Ethics approval(s)	Approved 02/06/2026, Geneva Cantonal Ethics Committee for Research Involving Human Subjects [Commission Cantonale d'Ethique de la Recherche sur l'être humain (CCER) du canton de Genève] (Commission cantonale d'éthique de la recherche (CCER), Rue Adrien-Lachenal 8, Geneva, 1207, Switzerland; +41225465101; ccer@etat.ge.ch), ref: 2026-00448
Health condition(s) or problem(s) studied	Body shame, dissatisfaction, concerns and negative body image.
Intervention	The target population includes young people from the French-speaking community in Switzerland aged 18–30 who identify as women (including transgender women). Prior evidence suggests the Body Project does not produce robust effects in men. While recent studies have included transgender women, the Body Project efficacy in this population remains unexplored. As the Body Project was originally developed based on cisgender women’s experiences, differences in adherence or retention may emerge. Gender and sex assigned at birth will be recorded to descriptively examine potential recruitment or retention issues and inform more inclusive future interventions. Randomisation: This study will use an individual randomisation design, with participants as the units of randomisation. A random allocation sequence will be generated in R and implemented in REDCap. Restricted randomisation (blocked randomisation) will be used to ensure balanced allocation (1:1) between the two intervention groups. Block sizes will vary to protect allocation concealment. Groups will be formed as participants join (with a target of six participants per group), and intervention sessions will start once a group has reached sufficient size. Intervention HEIDI+(intervention group): Participants will attend four 90-minute sessions via a videoconferencing platform, in groups of up to six people. This intervention includes discussions and exercises focused on the beauty ideals promoted in our society and how to protect oneself from them. The approaches used are cognitive dissonance and self-compassion. Intervention Body Project (active control group): Participants will be required to attend four 90-minute sessions via a videoconferencing platform, in groups of up to six people. This program also includes discussions and exercises focused on the ideals of beauty that are valued in our society and how to protect oneself from them. The approach used in this intervention is mainly cognitive dissonance. Both the HEIDI+ and Body Project interventions cover the same discussion topics, but the intervention techniques used differ. HEIDI+ employs techniques of cognitive dissonance and self-compassion. The Body Project uses only cognitive dissonance techniques. Cognitive dissonance involves leading discussions and exercises designed to help participants reexamine their beliefs. Self-compassion involves speaking to, treating, and encouraging oneself as one would a good friend.
Intervention type	Behavioural
Primary outcome measure(s)	Body shame measured using the Body Shame subscale of the Objectified Body Consciousness (OBC-BS) questionnaire at pre-intervention, post-intervention and 1-month follow-up
Key secondary outcome measure(s)	Body dissatisfaction measured using the Body Shape Questionnaire 8C (BSQ-8C) at pre-intervention, post-intervention and 1-month follow-up Beauty-ideal internalization measured using the Sociocultural Attitudes Towards Appearance Questionnaire-4-Revised (SATAQ-4R) at pre-intervention, post-intervention and 1-month follow-up Eating disorder psychopathology measured using the Eating Disorder Examination Questionnaire (EDE-Q) at pre-intervention, post-intervention and 1-month follow-up Self-compassion measured using the Self-Compassion Scale-Short Form (SCS-SF) at pre-intervention, post-intervention and 1-month follow-up Personality, to assess assertiveness, politeness/social compliance, perfectionism, measured using items from the 100 Nuances of Personality (100NP) at pre-intervention, post-intervention and 1-month follow-up
Completion date	31/01/2028

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	30 Years
Sex	Female
Target sample size at registration	60
Key inclusion criteria	1. Identifing as a woman 2. Living or working in Switzerland 3. Aged 18-30 years 4. Self-reported body dissatisfaction 5. Sufficient level of French to actively participate in the intervention
Key exclusion criteria	1. Meeting a current diagnostic criteria for any eating disorder according to the DSM-5-TR 2. Meeting the diagnostic criteria for a mood disorder or anxiety disorder 3. Pregnancy or lactation 4. Refusal to have the intervention sessions audio-recorded
Date of first enrolment	01/10/2026
Date of final enrolment	30/11/2027

Locations

Countries of recruitment

Switzerland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	Following the publication of the main article, the coded data will be shared in an open registry in accordance with the FAIR principles and under a CC-BY license, as requested by the SNF, which funded the project.

Editorial Notes

16/07/2026: Study’s existence confirmed by the Geneva Cantonal Ethics Committee for Research Involving Human Subjects, Switzerland.