Psychological DistressSPAIN-T1DMNCT07452393
Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations
An observational study of Psychological Distress and Eating Disorders, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Psychological Distress, Eating Disorders, Self Care
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2025to 20 Aug 2025
- How long will I take part?
- 1 Day
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Young participants aged 10 to 25 years with a diagnosis of type 1 diabetes, affiliated with diabetes associations or federations in Spain.
Who may be able to join
- 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).
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Psychological Distress, Eating Disorders, 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
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
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.
Measured: Day 1
Risk of Eating Disorders
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.
Measured: Day 1
Self-perceived Health Status
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."
Measured: Day 1
Secondary outcomes (9)
Age
Age will be recorded in years at the time of study participation.
Measured: Day 1
Gender
Gender will be self-reported by participants as part of the sociodemographic information.
Measured: Day 1
Diabetes Duration
Diabetes duration will be recorded as the number of years since the diagnosis of type 1 diabetes at the time of study participation.
Measured: Day 1
Weight
Weight will be self-reported by participants in kilograms at the time of study participation.
Measured: Day 1
Height
Height will be self-reported by participants in centimeters at the time of study participation.
Measured: Day 1
Body Mass Index (BMI)
BMI was calculated as weight (kg) divided by height squared (m²).
Measured: Day 1
Treatment Adherence
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.
Measured: Day 1
Adherence to the Mediterranean diet
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.
Measured: Day 1
Physical Activity
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start17 Feb 2025
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452393
- Sponsor's protocol ID
- UA-2024-09-27_2
- Acronym
- SPAIN-T1DM
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations
- ClinicalTrials.gov ID
- NCT07452393
- Acronym / sponsor ID
- SPAIN-T1DM / UA-2024-09-27_2
- Conditions
- Psychological Distress, Eating Disorders, Self Care, Type 1 Diabetes Mellitus (T1DM), Youth
- Keywords
- Psychological Distress, Eating Disorder Risk, Self-Care, Type 1 Diabetes Mellitus, Youth, Adherence, Diet, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 5 Mar 2026 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young participants aged 10 to 25 years with a diagnosis of type 1 diabetes, affiliated with diabetes associations or federations in Spain.
Key inclusion criteria (4 listed)
- 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).
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.
Primary outcome
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.
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.
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."
9 secondary outcomes
Age
Time frame: Day 1
Gender
Time frame: Day 1
Diabetes Duration
Time frame: Day 1
Weight
Time frame: Day 1
Height
Time frame: Day 1
Body Mass Index (BMI)
Time frame: Day 1
Treatment Adherence
Time frame: Day 1
Adherence to the Mediterranean diet
Time frame: Day 1
Physical Activity
Time frame: Day 1
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 11 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and Eating Disorders, run by University of Alicante at 1 site in Spain.
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 4 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Psychological Distress (time frame: Day 1). The study lists 3 primary outcomes in all. 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 11 Mar 2026.