Skip to main content
OpenTrials
Completed

NCT Number: NCT07452393

Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with type 1 diabetes mellitus (diagnosed).
  • Affiliated with any diabetes association or federation in Spain.
  • Aged between 10 and 25 years.
  • Individuals who are willing to participate (for adults) or whose legal guardians provide consent (for minors).

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Psychological Distress

    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.

  2. Risk of Eating Disorders

    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.

  3. Self-perceived Health Status

    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."

Secondary outcomes

  1. Age

    Time frame: Day 1

    Age will be recorded in years at the time of study participation.

  2. Gender

    Time frame: Day 1

    Gender will be self-reported by participants as part of the sociodemographic information.

  3. Diabetes Duration

    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.

  4. Weight

    Time frame: Day 1

    Weight will be self-reported by participants in kilograms at the time of study participation.

  5. Height

    Time frame: Day 1

    Height will be self-reported by participants in centimeters at the time of study participation.

  6. Body Mass Index (BMI)

    Time frame: Day 1

    BMI was calculated as weight (kg) divided by height squared (m²).

  7. Treatment Adherence

    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.

  8. Adherence to the Mediterranean diet

    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.

  9. Physical Activity

    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.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Acronym: SPAIN-T1DM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.