Study of the Characteristics of Orthorexia Nervosa in the Population Living With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— Santal-DT1  

Official title:

Study of the Characteristics of Orthorexia Nervosa in the Population Living With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546281
• Other study ID #: 2023-3914, 22258
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Laval University
• Contact: Sylvain Iceta, MD, PhD
• Phone: +1 (418) 656-8711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Person living with type 1 diabetes

• French speaking

• Between 18 and 35 years old

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Canada	Centre d'expertise Poids, Image et Alimentation (CEPIA)	Québec
Canada	IUCPQ	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stroop Task	Task aimed at evaluating the participant's inhibition and selective attention abilities.	Baseline
Secondary	Trail Making Test (TMT)	Task to assess the participant's cognitive flexibility.	Baseline
Secondary	Age	In years.	Baseline
Secondary	Gender		Baseline
Secondary	Weight	In kg.	Baseline
Secondary	Height	In meters.	Baseline
Secondary	Diabetes Information : Age of appearance and duration	In years.	Baseline
Secondary	Diabetes Information : How insulin is administered	Pumps or injections.	Baseline
Secondary	Diabetes Information : Total dose of insulin	For one day.	Baseline
Secondary	Diabetes Information : Duration of diabetes self-monitoring	Number of years or months of its use, either self-monitoring with capillary glucose tests or CGMS, if so.	Baseline
Secondary	Diabetes Information : Severe hypoglycemic episodes	Number of severe hypoglycemic episodes over the last year.	Baseline
Secondary	Diabetes Information : Diabetes complications	Number and type of diabetes complications.	Baseline
Secondary	Eating Habit Questionnaire (EHQ)	Questionnaires for the detection of orthorexic traits.; Individual subscale and total scale scores are summed, with higher scores indicating increased orthorexia nervosa tendencies.; The minimum score is 0 and the maximum score is 48.	Baseline
Secondary	Ortho-15 Questionnaire	Questionnaires for the detection of orthorexic traits.; The total score is obtained by adding the scores on each item. A low score on this tool indicates orthorexic tendencies.; The minimum score is 16 and the maximum is 39.	Baseline
Secondary	Eating Disorder Examination Questionnaire (EDE-Q)	Questionnaire for the detection of eating disorders.; The EDE-Q generates two types of data: frequency data on key behavioural features of eating disorders in terms of number of episodes of the behaviour, and subscale scores reflecting the severity of characteristics of eating disorders.Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes.; The minimum score is 0 and the maximum score is 6 for the subscales and the overall scale.	Baseline
Secondary	Type 1 Diabetes Distress Scale (T1-DDS)	Questionnaire for the assessment of type 1 diabetes distress.; The scale yields an overall distress score based on average responses along the 1-6 scale for all 28 items (range = 1-6).; The scale also yields a score for each of 7 subscales based on the average response on all of the items in that subscale (range = 1-6).; The higher the score, the higher the distress.	Baseline