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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07452393
Acronym
SPAIN-T1DM
Enrollment
115
Registered
2026-03-05
Start date
2025-02-17
Completion date
2025-08-20
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Psychological Distress, Self Care, Type 1 Diabetes Mellitus (T1DM), Youth

Keywords

Psychological Distress, Eating Disorder Risk, Self-Care, Type 1 Diabetes Mellitus, Youth, Adherence, Diet, Exercise, Adolescence

Brief summary

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.

Interventions

None listed

Sponsors

University of Alicante
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Psychological DistressDay 1Psychological 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.
Risk of Eating DisordersDay 1Risk 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.
Self-perceived Health StatusDay 1Self-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

MeasureTime frameDescription
AgeDay 1Age will be recorded in years at the time of study participation.
GenderDay 1Gender will be self-reported by participants as part of the sociodemographic information.
Diabetes DurationDay 1Diabetes duration will be recorded as the number of years since the diagnosis of type 1 diabetes at the time of study participation.
WeightDay 1Weight will be self-reported by participants in kilograms at the time of study participation.
HeightDay 1Height will be self-reported by participants in centimeters at the time of study participation.
Body Mass Index (BMI)Day 1BMI was calculated as weight (kg) divided by height squared (m²).
Treatment AdherenceDay 1Treatment 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.
Adherence to the Mediterranean dietDay 1Adherence 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.
Physical ActivityDay 1Physical 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026