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Идёт набор NCT05338944

Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)

Без фазы С лечением Prevention Type2Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dialectical behavioral therapy, Lifestyle.
Кому может быть актуально
Состояния в реестре: Prevention, Type2Diabetes. Базовые параметры: 14 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.

Вмешательства

  • Поведенческое Dialectical behavioral therapy
    Working with psychologists through DBT skills training.
  • Поведенческое Lifestyle
    Working with kinesiologist and registered dietician to improve lifestyle habits.

Первичные конечные точки

  • Enrollment rates [Срок оценки: 16 weeks]
  • Adherence to the intervention [Срок оценки: 16 weeks]
  • Retention for follow up measurements [Срок оценки: Measured at week 16 and week 32]
Вторичные конечные точки (12)
  • Quality of Life measure using the PedsQL questionnaire [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Body composition measured by dual-x-ray absorptiometry (DXA) [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Body Mass Index (BMI) z-score [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Emotional regulation [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Emotional reactive eating [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Depressive symptoms [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Psychological distress [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Anxiety symptoms [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Readiness for Lifestyle Behavior Change [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Behavior regulation in exercise [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Self-reported healthy lifestyle behaviors - physical activity and screen time [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]
  • Sleep habits [Срок оценки: Measured at baseline, 16 weeks and 32 weeks]

Критерии участия

Критерии включения

  • 14-17 years old
  • BMI z-score >1.4
  • signs of mild-moderate depression (PHQ-9 score 5-19)
  • willing and able to comply with study procedures

Критерии исключения

  • more than one health co-morbidity
  • being treated with medication for obesity
  • taking steroids
  • currently being treated for atypical antipsychotics
  • have an orthopedic injury or chronic illness that would prevent them from performing the intervention
  • experienced weight loss or enrolled in weight loss program in the six months prior to the study
  • they are currently and/or in the past 12 months have been prescribed any weight loss medication(s) including Ozempic
  • self reported history of alcoholism or drug abuse
  • history of self-harm or suicide attempts in the past 12 months
  • currently enrolled in psychotherapy or DBT
  • parents do not approve of you participating
  • unable to read, speak and understand English as translation will not be provided
  • unable/unwilling to give assent/consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Канада · 3 центра
  • University of Calgary — Calgary
  • University of Manitoba — Winnipeg
  • McMaster University — Hamilton

Публикации

  • Cameron EE, Morrison KM, Ho J, Roos L, Katz L, Mushquash A, Dart A, Wicklow BA, Senechal M, Jung ME, Strachan SM, Afifi TO, Archibald M, Andrade B, Hadjiyannakis S, Hamilton J, Slaght J, Penner K, Balshaw RF, McGavock J. Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot PMID 41688123

Идентификаторы

NCT: NCT05338944 · HS24295

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗