Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:31 AM
Study NCT ID:
NCT07452393
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological Distress', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Risk of Eating Disorders', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Self-perceived Health Status', 'timeFrame': 'Day 1', 'description': '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."'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Day 1', 'description': 'Age will be recorded in years at the time of study participation.'}, {'measure': 'Gender', 'timeFrame': 'Day 1', 'description': 'Gender will be self-reported by participants as part of the sociodemographic information.'}, {'measure': 'Diabetes Duration', 'timeFrame': 'Day 1', 'description': 'Diabetes duration will be recorded as the number of years since the diagnosis of type 1 diabetes at the time of study participation.'}, {'measure': 'Weight', 'timeFrame': 'Day 1', 'description': 'Weight will be self-reported by participants in kilograms at the time of study participation.'}, {'measure': 'Height', 'timeFrame': 'Day 1', 'description': 'Height will be self-reported by participants in centimeters at the time of study participation.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Day 1', 'description': 'BMI was calculated as weight (kg) divided by height squared (m²).'}, {'measure': 'Treatment Adherence', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Adherence to the Mediterranean diet', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Physical Activity', 'timeFrame': 'Day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychological Distress', 'Eating Disorder Risk', 'Self-Care', 'Type 1 Diabetes Mellitus', 'Youth', 'Adherence', 'Diet', 'Exercise', 'Adolescence'], 'conditions': ['Psychological Distress', 'Eating Disorders', 'Self Care', 'Type 1 Diabetes Mellitus (T1DM)', 'Youth']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young participants aged 10 to 25 years with a diagnosis of type 1 diabetes, affiliated with diabetes associations or federations in Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with type 1 diabetes mellitus (diagnosed).\n* Affiliated with any diabetes association or federation in Spain.\n* Aged between 10 and 25 years.\n* Individuals who are willing to participate (for adults) or whose legal guardians provide consent (for minors).\n\nExclusion Criteria:\n\n\\- None.'}, 'identificationModule': {'nctId': 'NCT07452393', 'acronym': 'SPAIN-T1DM', 'briefTitle': 'Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations', 'organization': {'class': 'OTHER', 'fullName': 'University of Alicante'}, 'officialTitle': 'Psychological Factors and Self-Care Behaviors in Spanish Youth With Type 1 Diabetes: Age- and Sex-Based Comparisons and Associations', 'orgStudyIdInfo': {'id': 'UA-2024-09-27_2'}}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'country': 'Spain', 'facility': 'University of Alicante, Faculty of Health Sciences', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}