Type 1 DiabetesSantal-DT1NCT05546281
Study of the Characteristics of Orthorexia Nervosa in the Population Living with Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Laval University at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 33 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Person living with type 1 diabetes
- French speaking
- Between 18 and 35 years old
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre d'expertise Poids, Image et Alimentation (CEPIA)
Québec
IUCPQ
Québec
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- No intervention
- Keywords
- Diabetes, Orthorexia nervosa, Eating Disorder, Mental Health
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Orthorexia Nervosa, Feeding and Eating Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (16)
Stroop Task
Task aimed at evaluating the participant's inhibition and selective attention abilities.
Measured: Baseline
Trail Making Test (TMT)
Task to assess the participant's cognitive flexibility.
Measured: Baseline
Age
In years.
Measured: Baseline
Gender
Measured: Baseline
Weight
In kg.
Measured: Baseline
Height
In meters.
Measured: Baseline
Diabetes Information : Age of appearance and duration
In years.
Measured: Baseline
Diabetes Information : How insulin is administered
Pumps or injections.
Measured: Baseline
Diabetes Information : Total dose of insulin
For one day.
Measured: Baseline
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.
Measured: Baseline
Diabetes Information : Severe hypoglycemic episodes
Number of severe hypoglycemic episodes over the last year.
Measured: Baseline
Diabetes Information : Diabetes complications
Number and type of diabetes complications.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
- Investigators
- Sylvain Iceta, MD, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546281
- Sponsor's protocol ID
- 2023-3914, 22258
- Acronym
- Santal-DT1
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Characteristics of Orthorexia Nervosa in the Population Living with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05546281
- Acronym / sponsor ID
- Santal-DT1 / 2023-3914, 22258
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Orthorexia nervosa, Eating Disorder, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Person living with type 1 diabetes
- French speaking
- Between 18 and 35 years old
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Forced food categorization task according to the categories "healthy / unhealthy"
Time frame: Baseline
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).
16 secondary outcomes
Stroop Task
Time frame: Baseline
Trail Making Test (TMT)
Time frame: Baseline
Age
Time frame: Baseline
Gender
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Diabetes Information : Age of appearance and duration
Time frame: Baseline
Diabetes Information : How insulin is administered
Time frame: Baseline
Diabetes Information : Total dose of insulin
Time frame: Baseline
Diabetes Information : Duration of diabetes self-monitoring
Time frame: Baseline
Diabetes Information : Severe hypoglycemic episodes
Time frame: Baseline
Diabetes Information : Diabetes complications
Time frame: Baseline
Eating Habit Questionnaire (EHQ)
Time frame: Baseline
Ortho-15 Questionnaire
Time frame: Baseline
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline
Type 1 Diabetes Distress Scale (T1-DDS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Iceta, MD, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced food categorization task according to the categories "healthy / unhealthy" (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.