University of Alicante, Faculty of Health Sciences
Alicante, Spain
NCT Number: NCT07452393
This is a multicenter, observational, cross-sectional study of young people aged 10 to 25 with type 1 diabetes in Spain, affiliated with a diabetes association or federation. Data will be collected through an online questionnaire in which participants voluntarily and anonymously self-report their responses. The study aims to assess psychological factors (psychological distress, risk of eating disorders, and self-perceived health status), health care behaviors (treatment adherence, diet, and physical activity), and sociodemographic data, exploring differences by age and sex and examining associations between variables.
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Notify Me10 year–25 year
All sexes
Observational
Alicante, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
Psychological distress was assessed using the 2-item Diabetes Distress Scale (DDS2; short form of the Diabetes Distress Scale), a validated questionnaire that measures diabetes-related emotional burden and distress associated with disease management. The scale consists of two items scored from 1 to 6. The final score is calculated as the mean of the two item responses, resulting in a total score ranging from 1 to 6, with higher scores indicating greater diabetes-related psychological distress. A score of ≥3 is considered indicative of clinically significant diabetes distress.
Time frame: Day 1
Risk of eating disorders was assessed using the Diabetes Eating Problem Survey-Revised (DEPS-R), a validated questionnaire that screens for disordered eating behaviors in individuals with type 1 diabetes. The questionnaire consists of 16 items rated on a 5-point Likert scale (never, sometimes, often, usually, or always). The total score is calculated by summing the item responses, resulting in a score ranging from 0 to 80, with higher scores indicating greater risk of disordered eating behaviors. A score of ≥20 is considered indicative of risk for an eating disorder in adolescents with type 1 diabetes.
Time frame: Day 1
Self-perceived health status will be assessed using a single-item question ("How healthy do you think you are?"), rated on a 5-point Likert scale, where 1 represents "very unhealthy" and 5 represents "very healthy."
Time frame: Day 1
Age will be recorded in years at the time of study participation.
Time frame: Day 1
Gender will be self-reported by participants as part of the sociodemographic information.
Time frame: Day 1
Diabetes duration will be recorded as the number of years since the diagnosis of type 1 diabetes at the time of study participation.
Time frame: Day 1
Weight will be self-reported by participants in kilograms at the time of study participation.
Time frame: Day 1
Height will be self-reported by participants in centimeters at the time of study participation.
Time frame: Day 1
BMI was calculated as weight (kg) divided by height squared (m²).
Time frame: Day 1
Treatment adherence was assessed using the Diabetes Management Questionnaire (DMQ), a validated instrument that evaluates adherence to prescribed diabetes care regimens. The questionnaire consists of 20 items rated on a 5-point Likert scale. The total score is calculated by summing the item responses, with some items reverse-scored, resulting in a total score ranging from 0 to 100, with higher scores indicating better adherence to diabetes self-management and treatment recommendations. No established clinical cut-off values exist for adolescents with type 1 diabetes.
Time frame: Day 1
Adherence to the Mediterranean diet was assessed using the KIDMED questionnaire, a validated instrument that evaluates dietary habits and quality in young people. The questionnaire consists of 16 items with yes/no responses, with some items scored positively and others negatively. The total score is calculated by summing the item responses, resulting in a total score ranging from 0 to 12. Higher scores indicate better adherence to the Mediterranean diet. Adherence is categorized as follows: 8 points - Optimal Mediterranean diet, indicating excellent adherence; 4-7 points - Needs improvement, indicating a need to adjust dietary patterns toward the Mediterranean model; ≤3 points - Very low-quality diet, indicating poor adherence.
Time frame: Day 1
Physical activity was assessed using the Adolescent Physical Literacy Questionnaire (APALQ), a validated instrument that measures frequency, duration, and intensity of physical activity in young people. The questionnaire consists of 5 items rated on a Likert-type scale (never, 1-2 times a month, once a week, 2-3 times a week, and 4 or more times a week). The total score is calculated by summing the item responses, resulting in a total score ranging from 5 to 25, with higher scores indicating greater frequency and intensity of physical activity.
University of Alicante
Other
Acronym: SPAIN-T1DM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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