Anorexia NervosaFIATNCT06759402
Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
A study testing Family based treatment and Inpatient multimodal therapy in people with Anorexia Nervosa and Anorexia in Adolescence, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anorexia Nervosa, Anorexia in Adolescence
- What is being tested?
- Family based treatment and Inpatient multimodal therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- restrictive and bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
- inpatient treatment indication according to S3 guideline
- weight < 3. BMI-percentile or
- weight <10. percentile and psychiatric comorbidity/rapid weight loss/lack of weight gain during outpatient treatment over last three month
- planned inpatient treatment
- insured with one of the participating health insurance companies
- stable internet connection
Who cannot join
- weight <67%mBMI
- acute self harm or danger to others
- acute psychosis or suicidal tendencies
- current substance abuse
- child abuse or domestic violence in the family
- insured with other health insurance company
- judicial placement order for inpatient treatment
- known, currently existing child protection problems or proceedings by the family court
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité- Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Verena K. Haas, Dr. oec. troph., +4930 450 566 399, verena.haas@charite.de
Piet E. Adler, M.Sc., +4930 450 566 597, piet.adler@charite.de
About this study
The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. The primary aim of this study is to compare Family-Based Treatment delivered via telehealth (FBT) with inpatient multimodal therapy (IMT) with respect to treatment outcomes and health economic data. The results of the study will serve as a basis for the decision on the inclusion of FBT in the German S3 guidelines and the future reimbursement of FBT by public health insurances in Germany.
- Conditions
- Anorexia Nervosa, Anorexia in Adolescence
- Being tested
- Family based treatment, Inpatient multimodal therapy
- Keywords
- Psychotherapy, Family Based Treatment, RCT, Inpatient Treatment
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family based treatmentBehavioural
FBT is an intensive, manualized therapy in which the parents of those affected are closely involved in a resource-oriented manner by FBT-certified therapists. FBT takes place in 3 phases: in phase 1, the parents take responsibility for their child's weight gain. Phase 2 involves the gradual transfer of responsibility for eating back to the patient. Phase 3 focuses on individual issues of the children and adolescents, e.g. catching up on important developmental steps missed due to the illness.
Inpatient multimodal therapyBehavioural
comprehensive, patient-oriented and multidisciplinary approach to address eating disorders following the S3 joint German treatment guidelines in specialized hospitals. Includes individual psychotherapy, family sessions, body-oriented therapy, nutritional counseling, group therapy sessions, relaxation techniques, mindfulness practices, and skills training. Targeted weight gain per week is at least 500g.
| Study group | Role | What they receive |
|---|---|---|
| FBT | Experimental | family-based therapy as a stepped care model using telemedicine Receives: Behavioral: Family based treatment |
| IMT | Active comparator | inpatient multimodal therapy Receives: Behavioral: Inpatient multimodal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in %mBMI
The %mBMI is calcualted based on bodyweight and height, measured by the study team. Change is the difference between the baseline and 12 month %mBMI.
Measured: 12 months
Secondary outcomes (17)
Specific psychopathology for anorexia nervosa
Measured by the eating disorder examination-questionnaire (EDE-Q). The scores of the EDE-Q are presented on a scale between 0 and 6, where higher scores mean higher presence of symptoms.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Compulsive exercise
Measured by the compulsive exercise test (CET). Items are rated on a 6-point Likert type scale from 0 (never true) to 5 (always true), with higher scores correspond with stronger symptoms.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Depression
Measured by the Revised Children's Anxiety and Depression Scale (RCADS). Scores are presented between 0 (never) to 3 (always). The total score is converted into a T-score. Higher T-scores indicate higher presence of symptoms.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Occurrence of adverse events
Measured by the modified over aggression scale (MOAS) in addition with a set serious adverse events list. Higher scores on the MOAS indicate more severe cases of aggressive behaviors.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Menstrual status
Measured by structural interview.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Medication
Measured by structural interview.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Motivation for change
Measured by the anorexia nervosa stages of change questionnaire (ANSOCQ). Each item can scored between 1 and 5. Higher scores indicate higher levels of motivation.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Insight into illness
One item "On a scale of 1 to 10, how severe would you rate yourself as suffering from anorexia?" where a higher score indicates more insight into the illness.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Change in eating disorder quality of life
Measured by the eating disorder quality of life (EDQOL). Each item can be scored on a 6-point scale ranging from 0 ("never") to 5 ("always"). Higher scores indicate lower quality of life.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Change in quality of life
Measured by the EQ-5D-Y-5L. Items are scored on 5 levels ("no problems" to "extreme problems") except one, which is scored on a vertical visual analogue scale (endpoints are "the best health you can imagine" and "the worst health you can imagine"). Higher scores indicate more problems.
Measured: 6 months after baseline and 12 months after baseline.
Emotional and financial burden on the legal guardians
Measured by the caregiver strain questionnaire (CGSQ-SF11). Items are scored on a 5-point Likert scale (0= not at all, 4= very much). Higher scores indicate greater strain.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Financial burden on the legal guardians
Measured by a structured questionnaire about financial strain during treatment. The first question ("Has your child's treatment put a financial strain on you?") is scored on a 4-point Likert scale (1= not at all; 4= extremely). A higher score indicates greater financial strain. The second question ("Have you had any loss of earnings due to your child's illness?") is binary scored (yes/no) and follows up the "yes" condition with the question "how many days were you not able to work?".
Measured: 6 months after baseline and 12 months after baseline.
Utilization and costs of healthcare services
Measured by the Client Service Receipt Inventory (CSRI). Assessing the use of various services in the respective units (e.g., days or hours).
Measured: 6 months after baseline and 12 months after baseline.
Satisfaction with treatment for patients
Measured by an adapted version of the treatment satisfaction questionnaire by Lindstedt et al. (2020). The following topics are assessed and scored:
- Helpfulness of therapy-elements. Higher scores indicate less helpfulness
- Patient-therapist-interaction. Higher scores indicate less positive experiences of interaction.
- Treatment goals importance. Higher scores indicate less importance of proposed treatment goals.
- Achievement of treatment goals. Higher scores indicate less achievement of proposed treatment goals.
- Change in symptoms (before treatment vs. after treatment). Higher scores indicate more positive change in symptoms.
Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Satisfaction with treatment for parents (Likert scale items)
Measured by an adapted version of the treatment satisfactory questionnaire by Krautter \& Lock (2004). The questions assess the subjective effectiveness of the treatment and treatment satisfaction. Items are scored on all topics on a 5-point Likert scale (0= very ineffective; 4= very effective). Higher scores indicate higher effectiveness. Additionally, the following questions are scored on a 5-point Likert scale (0= not at all; 4= yes, totally) :
- "Do you agree that the team that treated your child is competent?"
- "Would you recommend this treatment?"
Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Satisfaction with treatment for parents (Free-text items)
Measured by an adapted version of the treatment satisfactory questionnaire by Krautter \& Lock (2004). The questions assess the subjective effectiveness of the treatment and treatment satisfaction. Two open questions ("What did you find helpful in this treatment?"; "What did you not find helpful in this treatment?") can be answered via free-text.
Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Suicidality
Measured by asking first whether any suicidal thoughts or behaviors were present in the past 28 days (yes/no). The yes condition is followed up by several questions assessing the presence (yes/no) of:
- passive suicidal thoughts.
- active suicidal thoughts.
- active suicidal thoughts with plan.
- active suicidal thoughts with plan and preparation.
- active suicidal thoughts with plan and intention to act upon it.
- suicidal behaviors, stopped by oneself.
- suicidal behaviors, stopped by others.
- suicidal behaviors, carried out, light physical damage.
- suicidal behaviors, carried out, medium physical damage.
- suicidal behaviors, carried out, severe physical damage.
- suicidal behaviors, carried out, death.
Both children and parents are asked. The children answer for their own thoughts/behaviors, the parents for their child's thoughts/behaviors.
Measured: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start31 Jan 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentred, longitudinal, randomized controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bielefeld University, Techniker Krankenkasse, BARMER, AOK Niedersachsen, Mobil Krankenkasse, Meine Krankenkasse, Medicalnetworks CJ GmbH & Co.KG, AOK Baden-Württemberg, DAK Gesundheit, BIG-direkt, mhplus, Bahn-BKK, OFFIS - Institut für Informatik, Prof. Daniel Le Grange, UCSF
- Responsible party
- Principal investigator, Prof. Dr. med Christoph Correll, Charite University, Berlin, Germany
- Investigators
- Christoph U Correll, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759402
- Sponsor's protocol ID
- EA2/114/24
- Acronym
- FIAT
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krautter, Tonja, and James Lock. "Is manualized family-based treatment for adolescent anorexia nervosa acceptable to patients? Patient satisfaction at the end of treatment." Journal of Family Therapy 26.1 (2004): 66-82.
Lindstedt K, Forss E, Elwin M, Kjellin L, Gustafsson SA. Adolescents with full or subthreshold anorexia nervosa in a naturalistic sample: treatment interventions and patient satisfaction. Child Adolesc Psychiatry Ment Health. 2020 May 2;14:16. doi: 10.1186/s13034-020-00323-9. eCollection 2020.
PubMed 32391079Haas V, Wechsung K, Kaiser V, Schmidt J, Raile K, Busjahn A, Le Grange D, Correll CU. Comparing family-based treatment with inpatient treatment in youth with anorexia nervosa eligible for hospitalization: A 12-month feasibility study. Int J Eat Disord. 2024 Feb;57(2):388-399. doi: 10.1002/eat.24098. Epub 2023 Dec 11.
PubMed 38082440
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
- ClinicalTrials.gov ID
- NCT06759402
- Acronym / sponsor ID
- FIAT / EA2/114/24
- Conditions
- Anorexia Nervosa, Anorexia in Adolescence
- Keywords
- Psychotherapy, Family Based Treatment, RCT, Inpatient Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Bielefeld University, Techniker Krankenkasse, BARMER, AOK Niedersachsen, Mobil Krankenkasse, Meine Krankenkasse, Medicalnetworks CJ GmbH & Co.KG, AOK Baden-Württemberg, DAK Gesundheit, BIG-direkt, mhplus, Bahn-BKK, OFFIS - Institut für Informatik, Prof. Daniel Le Grange, UCSF
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. The primary aim of this study is to compare Family-Based Treatment delivered via telehealth (FBT) with inpatient multimodal therapy (IMT) with respect to treatment outcomes and health economic data. The results of the study will serve as a basis for the decision on the inclusion of FBT in the German S3 guidelines and the future reimbursement of FBT by public health insurances in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicentred, longitudinal, randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| FBT | Experimental | Behavioral: Family based treatmentfamily-based therapy as a stepped care model using telemedicine |
| IMT | Active comparator | Behavioral: Inpatient multimodal therapyinpatient multimodal therapy |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- restrictive and bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
- inpatient treatment indication according to S3 guideline
- weight < 3. BMI-percentile or
- weight <10. percentile and psychiatric comorbidity/rapid weight loss/lack of weight gain during outpatient treatment over last three month
- planned inpatient treatment
Key exclusion criteria (8 listed)
- weight <67%mBMI
- acute self harm or danger to others
- acute psychosis or suicidal tendencies
- current substance abuse
- child abuse or domestic violence in the family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family based treatmentFBT is an intensive, manualized therapy in which the parents of those affected are closely involved in a resource-oriented manner by FBT-certified therapists. FBT takes place in 3 phases: in phase 1, the parents take responsibility for their child's weight gain. Phase 2 involves the gradual transfer of responsibility for eating back to the patient. Phase 3 focuses on individual issues of the children and adolescents, e.g. catching up on important developmental steps missed due to the illness. | Behavioural | FBT |
| Inpatient multimodal therapycomprehensive, patient-oriented and multidisciplinary approach to address eating disorders following the S3 joint German treatment guidelines in specialized hospitals. Includes individual psychotherapy, family sessions, body-oriented therapy, nutritional counseling, group therapy sessions, relaxation techniques, mindfulness practices, and skills training. Targeted weight gain per week is at least 500g. | Behavioural | IMT |
Primary outcome
Change in %mBMI
Time frame: 12 months
The %mBMI is calcualted based on bodyweight and height, measured by the study team. Change is the difference between the baseline and 12 month %mBMI.
17 secondary outcomes
Specific psychopathology for anorexia nervosa
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Compulsive exercise
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Depression
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Occurrence of adverse events
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Menstrual status
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Medication
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Motivation for change
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Insight into illness
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Change in eating disorder quality of life
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Change in quality of life
Time frame: 6 months after baseline and 12 months after baseline.
Emotional and financial burden on the legal guardians
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Financial burden on the legal guardians
Time frame: 6 months after baseline and 12 months after baseline.
Utilization and costs of healthcare services
Time frame: 6 months after baseline and 12 months after baseline.
Satisfaction with treatment for patients
Time frame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Satisfaction with treatment for parents (Likert scale items)
Time frame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Satisfaction with treatment for parents (Free-text items)
Time frame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
Suicidality
Time frame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- BackgroundKrautter, Tonja, and James Lock. "Is manualized family-based treatment for adolescent anorexia nervosa acceptable to patients? Patient satisfaction at the end of treatment." Journal of Family Therapy 26.1 (2004): 66-82.
- Background: PubMed 32391079Lindstedt K, Forss E, Elwin M, Kjellin L, Gustafsson SA. Adolescents with full or subthreshold anorexia nervosa in a naturalistic sample: treatment interventions and patient satisfaction. Child Adolesc Psychiatry Ment Health. 2020 May 2;14:16. doi: 10.1186/s13034-020-00323-9. eCollection 2020.
- Background: PubMed 38082440Haas V, Wechsung K, Kaiser V, Schmidt J, Raile K, Busjahn A, Le Grange D, Correll CU. Comparing family-based treatment with inpatient treatment in youth with anorexia nervosa eligible for hospitalization: A 12-month feasibility study. Int J Eat Disord. 2024 Feb;57(2):388-399. doi: 10.1002/eat.24098. Epub 2023 Dec 11.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph U Correll, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family based treatment and Inpatient multimodal therapy in people with Anorexia Nervosa and Anorexia in Adolescence, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Verena K. Haas, Dr. oec. troph. (+4930 450 566 399, verena.haas@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %mBMI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759402, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.