NCT04564170

Brief Summary

This is an observational study where patients with eating disorders (ED) are compared with healthy controls without eating disorder (HC) regarding eating disorders features and autism spectrum features. Also patients will be reassessed after 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

September 21, 2020

Last Update Submit

February 25, 2025

Conditions

Eating Disorders

Keywords

eating disordersautism spectrum disorders

Outcome Measures

Primary Outcomes (2)

  • Autism Spectrum Quotient

    A self report measure of autism traits. Its values range from 0 to 50. Higher scores mean higher autistic traits.

    one year

  • Eating Disorders Inventory

    A self report measure of Eating Disorders characteristics. Its values range from 0 to 192, higher values mean higher eating disorders symptomatology.

    one year

Secondary Outcomes (8)

  • Bulimic Investigatory Test Edinburgh

    one year

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    one year

  • Beck Depression Inventory

    one year

  • Scale Unawareness of Mental Disorders.

    one year

  • Body Shape Questionnaire

    one year

  • +3 more secondary outcomes

Study Arms (2)

ED

Patients with Eating Disorders

HC

Healthy Controls without eating disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ED and HC without ED.

You may qualify if:

  • Being Diagnosed with ED

You may not qualify if:

  • language or intellectual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Carmona

Barcelona, Barcelona, 08041, Spain

Location

Related Publications (11)

  • Atienza, F., Moreno, Y., & Balaguer, I. (2000). Escala de autoestima de Rosenberg. Recuperado de: https://www. uv. es/uipd/cuestionarios/accesolibre/EAR.

    BACKGROUND

  • Beck, A. T., Steer, R. A., & Brown, G. K. (1996). BDI-II: Beck depression inventory. Pearson.

    BACKGROUND

  • Bentz M, Jepsen JRM, Pedersen T, Bulik CM, Pedersen L, Pagsberg AK, Plessen KJ. Impairment of Social Function in Young Females With Recent-Onset Anorexia Nervosa and Recovered Individuals. J Adolesc Health. 2017 Jan;60(1):23-32. doi: 10.1016/j.jadohealth.2016.08.011. Epub 2016 Oct 27.

    PMID: 28341015BACKGROUND

  • Cooper, P. J., Taylor, M. J., Cooper, Z., & Fairbum, C. G. (1987). The development and validation of the Body Shape Questionnaire. International Journal of eating disorders, 6(4), 485-494.

    BACKGROUND

  • First, M. B. (2015). DSM-5 : Manual de diagnóstico diferencial (DSM-V). Editorial Médica Panamericana.

    BACKGROUND

  • Huke V, Turk J, Saeidi S, Kent A, Morgan JF. Autism spectrum disorders in eating disorder populations: a systematic review. Eur Eat Disord Rev. 2013 Sep;21(5):345-51. doi: 10.1002/erv.2244. Epub 2013 Jul 31.

    PMID: 23900859BACKGROUND

  • Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.

    PMID: 28630708BACKGROUND

  • Nielsen S, Anckarsater H, Gillberg C, Gillberg C, Rastam M, Wentz E. Effects of autism spectrum disorders on outcome in teenage-onset anorexia nervosa evaluated by the Morgan-Russell outcome assessment schedule: a controlled community-based study. Mol Autism. 2015 Mar 8;6:14. doi: 10.1186/s13229-015-0013-4. eCollection 2015.

    PMID: 25774282BACKGROUND

  • Oldershaw A, Treasure J, Hambrook D, Tchanturia K, Schmidt U. Is anorexia nervosa a version of autism spectrum disorders? Eur Eat Disord Rev. 2011 Nov-Dec;19(6):462-74. doi: 10.1002/erv.1069. Epub 2011 Jan 30.

    PMID: 21280165BACKGROUND

  • Spielberger, C. D., Gorsuch, R. L., Lushene, R. E., Vagg, P. R., & Jacobs, G. A. (1970). Manual for the state-trait inventory. Consulting Psychologists, Palo Alto, California.

    BACKGROUND

  • Westwood H, Eisler I, Mandy W, Leppanen J, Treasure J, Tchanturia K. Using the Autism-Spectrum Quotient to Measure Autistic Traits in Anorexia Nervosa: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2016 Mar;46(3):964-77. doi: 10.1007/s10803-015-2641-0.

    PMID: 26542816BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

April 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 20, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)