i-BEAT: Binge-Eating Adolescent And Young Adults Treatment – a training program for youth and young adults with binge-eating

Phase 3

Recruiting

• Conditions: Binge Eating DisorderLoss of Control EatingBinge Eating Episodes; F50.8; Other eating disorders

• Registration Number: DRKS00023706
• Lead Sponsor: niversität Fribourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-27
• Results First Posted: 2024-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Youth suffering from LOC:
Participants fulfilling inclusion criteria are eligible for the study:
- Willingness and self-reported motivation to participate
- Gender: males, females and others
- Age: 14-24 years (according to the term youth defined e.g. by the UN)
- Full diagnosis of BED according to DSM-5
- Subclinical BED or LOC (loss of control eating over a subjective amount of food, which does not fulfil the criteria of an objective large amount of food of a fully developed BED (subjective binges): 3 episodes of objective binge episodes or LOC during the last 3 months accompanied by at least 3 out of 5 behavioural indicators (according to DSM-5) and/ or some degree of distress.
- Informed Consent as documented by signature: Patients need to give informed consent about the procedure (study 1: questionnaire-base and/or App-based study, and/or study 2: VR Cyberball game and/or epigenetics, and/ or study 3: i-BEAT trial) and confirm their willingness to participate in the full research program (study 1 – 3) or single studies (questionnaire based and/or App-based study 1, study 2 (Cyberball and/or epigenetics) and/or treatment study 3 or combinations of studies.

Youth participating in the HCG:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Willingness and self-reported motivation to participate
- Gender: males, females and others
- Age: 14-24 years (according to the term youth defined e.g. by the UN)
- Healthy body weight (BMI 18.5-24.9)
- No past or present eating disorder and absence of any present mental disorder
- Informed Consent as documented by signature: Patients need to give informed consent about the procedure (study 1: questionnaire-base and App-based study, and/or study 2: Cyberball and epigenetics) and confirm their willingness to participate in the full research program (questionnaire-based and App-based study 1 and 2 (Cyberball and epigenetics) or only in study 1 (questionnaire-based and/or App-based study 1) or study 2 (Cyberball and/or epigenetics: participants in the HCG will not attend i-BEAT study 3 and therefore study 3 will not be part of the informed consent of the HCG).

Exclusion Criteria

The presence of any of the following exclusion criteria will lead to exclusion of the participant:
- Language/ skills: Patients will be excluded if they do not have self-reported sufficient German language skills
- Current or past mental disorder
- Pregnancy (App-based study 1, study 2 and 3)
- Previous enrolment in the study

Additional in- and exclusion criteria apply for study 2, where youth must have intact or corrected vision capacity and are excluded if they report nausea in VR.

Study & Design

• Study Type: interventional
• Study Design: Not specified