NCT05801016

Brief Summary

Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

March 8, 2023

Last Update Submit

March 23, 2023

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Change in estimation of body weight

    Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)

    At baseline and after 12 months

Study Arms (2)

Anorexia nervosa

OTHER

Female anorexia nervosa patients

Behavioral: Emerging Technologies and Training in Neurosciences

Healthy controls

OTHER

Healthy female control participants

Behavioral: Emerging Technologies and Training in Neurosciences

Interventions

Emerging Technologies and Training in NeurosciencesBEHAVIORAL

Combination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall

Anorexia nervosaHealthy controls

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anorexia Nervosa
  • Body mass index equal or superior to 15 kg/m2
  • Mother tongue Italian
  • Semiresidential rehabilitation program

You may not qualify if:

  • Other eating disorders
  • Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20100, Italy

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Giuseppe Riva, prof

    università cattolica Milano

    STUDY DIRECTOR

Central Study Contacts

Luca Persani, MD PhD

CONTACT

390261911;luca.persani@unimi.it;

Nicoletta Polli, MD

CONTACT

390261911n.polli@auxologico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 6, 2023

Study Start

June 28, 2019

Primary Completion

March 8, 2023

Study Completion

January 1, 2024

Last Updated

April 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)