NCT05546281

Brief Summary

In the general population, the excessive and constant desire to control one's diet and body has become increasingly problematic. Indeed, the demand for control over one's diet and body is now an unspoken social prescription that can lead in some cases to eating disorders. In patients with type 1 diabetes (T1D), these concerns are even more central, as they are accentuated by the very nature of the treatment of the disease (dietary modification, insulin compensation according to food intake, etc.). Studies on adolescents with T1D show that the prevalence of eating disorders would be present in at least 1 in 5 patients. Among these disorders, orthorexia is of particular interest. Indeed, orthorexia was defined in 1997 by Steven Bratman as a rigid eating behavior based on the avoidance of foods considered qualitatively unhealthy. More precisely, orthorexia is characterized by a constant preoccupation with one's diet and persistent nutritional (or health) beliefs that take precedence over food pleasure. It has been estimated that the prevalence of orthorexia in patients living with T1D may be as high as 80%. We are currently conducting a study on the mechanisms of orthorexia in the general population of Quebec (the results of phase 1 of this study are being analyzed). We now wish to conduct the same study in a population with T1D, which has a higher prevalence of people with orthorexia nervosa. The main objective of this study is to investigate the characteristics of orthorexia nervosa (obsessions and fixations on healthy eating) in the Quebec population with T1D from the BETTER Registry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

September 16, 2022

Last Update Submit

October 7, 2024

Conditions

Keywords

DiabetesOrthorexia nervosaEating DisorderMental Health

Outcome Measures

Primary Outcomes (1)

  • Forced food categorization task according to the categories "healthy / unhealthy"

    Instruction to the participant: "Classify the food that appears on your screen as quickly as possible, either as "healthy" (key E) or "unhealthy" (key I). Each response and the associated reaction time will be recorded. Stimuli must be classified by the participant as quickly as possible, if the stimulus is not classified before 3 sec the participant moves to the next observation and the stimulus is recorded as NC (not classified).

    Baseline

Secondary Outcomes (16)

  • Stroop Task

    Baseline

  • Trail Making Test (TMT)

    Baseline

  • Age

    Baseline

  • Gender

    Baseline

  • Weight

    Baseline

  • +11 more secondary outcomes

Interventions

No intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study will include data from people living with type I diabetes who participated in the baseline phase of the BETTER registry.

You may qualify if:

  • Person living with type 1 diabetes
  • French speaking
  • Between 18 and 35 years old

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'expertise Poids, Image et Alimentation (CEPIA)

Québec, Canada

Location

IUCPQ

Québec, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusOrthorexia NervosaFeeding and Eating DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Sylvain Iceta, MD, PhD

    Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Assitant Professor

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 19, 2022

Study Start

October 1, 2022

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations