Clinical trial NCT05546281: Study of the Characteristics of Orthorexia Nervosa in the Population Living with Type 1 Diabetes
Official title: Study of the Characteristics of Orthorexia Nervosa in the Population Living with Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Diabetes
Orthorexia nervosa
Eating Disorder
Mental Health
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: The BETTER registry is supervised by Dr. Rabasa-Lhoret and Dr. Brazeau and co-funded by CIHR and JDRF: more than 2000 patients with T1D are currently in the registry, of which 98% of the participants have agreed to be contacted for future research studies. This will be done by comparing food categorization strategies between control subjects from the previous study (results under analysis) and subjects with orthorexia nervosa traits in the T1D patient population, and also by testing the hypothesis of dysfunctions specific to the orthorexia population of executive functions (including attention, cognitive flexibility, inhibition and working memory) in the general domain and then more specifically in the food domain.

Considering the existing literature on orthorexia described above, and in particular the definition of orthorexia nervosa (orthorexia nervosa is defined as obsessions and fixations on healthy eating leading to negative emotional and behavioral consequences for the individual, e.g., excessive anxiety, social isolation), as well as the strong correlations observed in the literature between distress, anxiety, and diabetes, the hypotheses are the following:

* Hypothesis 1: The more orthorexic traits subjects exhibit, the more quickly they categorize foods into healthy/unhealthy.
* Hypothesis 2: The likelihood that a food, regardless of its properties, will be categorized as unhealthy is greater the more orthorexic traits the subjects exhibit.
* Hypothesis 3: The more orthorexic traits subjects exhibit, the more stable they respond (i.e., they respond in the same way to each repetition of the same stimulus) when it comes to categorizing a food as good or bad for health.
* Hypothesis 4: The more severe the orthorexia behaviors, the more distressing the patients will express about their T1D.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Forced food categorization task according to the categories "healthy / unhealthy"
timeFrame: Baseline
Secondary outcomes:
measure: Stroop Task
timeFrame: Baseline
measure: Trail Making Test (TMT)
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Diabetes Information : Age of appearance and duration
timeFrame: Baseline
measure: Diabetes Information : How insulin is administered
timeFrame: Baseline
measure: Diabetes Information : Total dose of insulin
timeFrame: Baseline
measure: Diabetes Information : Duration of diabetes self-monitoring
timeFrame: Baseline
measure: Diabetes Information : Severe hypoglycemic episodes
timeFrame: Baseline
measure: Diabetes Information : Diabetes complications
timeFrame: Baseline
measure: Eating Habit Questionnaire (EHQ)
timeFrame: Baseline
measure: Ortho-15 Questionnaire
timeFrame: Baseline
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline
measure: Type 1 Diabetes Distress Scale (T1-DDS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre d'expertise Poids, Image et Alimentation (CEPIA)
city: Québec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
name: Sylvain Iceta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: