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. 2019 Jan 30;20(1):91.
doi: 10.1186/s13063-018-3161-y.

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium

Stephanie Bauer  1 , Sally Bilić  2 , Christina Reetz  2 , Fikret Ozer  2 , Katja Becker  3 , Heike Eschenbeck  4 , Michael Kaess  5   6 , Christine Rummel-Kluge  7 , Hans-Joachim Salize  8 , Silke Diestelkamp  9 , Markus Moessner  2 ; ProHEAD Consortium
Collaborators, Affiliations

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium

Stephanie Bauer et al. Trials. .

Abstract

Background: The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The present trial evaluates the efficacy and cost-effectiveness of two new interventions (based on dissonance theory and principles of cognitive behavioral therapy (CBT)) that are implemented as add-ons to the existing Internet-based ED prevention program ProYouth.

Methods: The trial is one of five sub-projects of the German multicenter consortium ProHEAD. It is a three-arm, parallel, randomized controlled superiority trial. Participants will be randomized to (1) the online program ProYouth (active control condition) or (2) ProYouth plus a structured dissonance-based module or (3) ProYouth plus a CBT-based chat group intervention. As part of ProHEAD, a representative school-based sample of N = 15,000 students (≥ 12 years) will be screened for mental health problems. N = 309 participants at risk for ED (assessed with the Weight Concerns Scale (WCS) and the Short Evaluation of Eating Disorders (SEED)) will be included in the present trial. Online assessments will be conducted at baseline, at end of intervention (6 weeks), at 6 months follow-up, and - as part of ProHEAD - at 12 and 24 months follow-up. The primary outcome is ED-related impairment (assessed with the Child version of the Eating Disorder Examination-Questionnaire (ChEDE-Q)) at the end of the intervention. Secondary outcomes include ED-related symptomatology at follow-up, ED-related stigma, ED-related help-seeking, and acceptance of and compliance with the interventions. For the health economic evaluation data on costs of the interventions, healthcare utilization and health-related quality of life will be assessed.

Discussion: This is the first study augmenting a flexible prevention approach such as ProYouth with structured evidence-based modules in order to overcome some of the key limitations in the current practice of ED prevention.

Trial registration: German Clinical Trials Register (DRKS), DRKS00014679 . Registered on 25 April 2018.

Keywords: CBT; Dissonance; Eating disorders; Internet; Prevention; ProHEAD.

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Conflict of interest statement

Ethics approval and consent to participate

The ProHEAD Consortium including the present trial was reviewed and approved by the ethics committee of the University Hospital Heidelberg, on April, 19 (reference number: S-086/2018). Subsequently, ethical approval is sought at all other study sites recruiting participants (Hamburg, Leipzig, Marburg, Schwäbisch Gmünd).

The trial will follow the Declaration of Helsinki and the Guidelines for Good Clinical Practice (ICH-GCP) in their latest revision. Written informed consent and assent will be obtained from all participating C&A and from at least one of their primary caregivers. The Internet-based platforms to assess data and to deliver the interventions will follow latest regulations concerning data security. All collected information will be confidential and held in accordance with ICH-GCP. Participants will be free to withdraw consent from the study at any time without stating reasons.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow diagram. Notes: C&A children and adolescents, BMI body mass index, WCS Weight Concerns Scale, SP2 sub-project 2, SP1 sub-project 1 [29], CP ProHEAD central project
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments. Notes: –t1 prior to participation, Sociodemograph. sociodemographic characteristics, WCS Weight Concerns Scale, EDE-Q (Child version of the) Eating Disorder Examination-Questionnaire, SEED Short Evaluation of Eating Disorders, GHSQ General Help-Seeking Questionnaire, USS Universal Stigma Scale, SATAQ-G German version of the Sociocultural Attitudes Towards Appearance Questionnaire, BSQ-8C 8-item version of the Body Shape Questionnaire, ZUF-8 German version of the Client Satisfaction Questionnaire
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