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临床试验/NCT07452393
NCT07452393已完成不适用

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

University of Alicante1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
Psychological Distress

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 未提供

结局指标

主要结局

Psychological Distress

时间窗: 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

时间窗: 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

时间窗: 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."

次要结局

  • Weight(Day 1)
  • Age(Day 1)
  • Gender(Day 1)
  • Diabetes Duration(Day 1)
  • Height(Day 1)
  • Body Mass Index (BMI)(Day 1)
  • Treatment Adherence(Day 1)
  • Adherence to the Mediterranean diet(Day 1)
  • Physical Activity(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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