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Идёт набор NCT06755827

Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Фаза I / Фаза II С лечением Overweight Adolescents Obese Adolescents

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: Emotion regulation and self-monitoring to treat pediatric obesity, Psychoeducation.
Кому может быть актуально
Состояния в реестре: Overweight Adolescents, Obese Adolescents. Базовые параметры: 11 лет — 14 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Emotion Regulation Intervention to Improve Neural Responsiveness and Health

Обзор

The goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. The main question it aims to answer is: * Does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity? * Do changes in biases relate to changes in health functioning and health behavior? Researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective. Participants will: * Complete self-report questionnaires, an fMRI scan, and have their blood drawn * Received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions * Return to complete the same questionnaires, fMRI and blood draw procedures

Вмешательства

  • Поведенческое Emotion regulation and self-monitoring to treat pediatric obesity
    Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
  • Другое Psychoeducation
    Participants who are randomized to the control group will receive an online, one-time, self-led psychoeducation program with information about current daily sleep, diet, and physical activity recommendations (e.g., information about sleep hygiene, the food pyramid, and recommendations for 60 minutes of moderate-to-vigorous physical activity daily).

Первичные конечные точки

  • Percentage BOLD (Blood Oxygenation Level Dependent) signal change [Срок оценки: From enrollment to the end of treatment at week 5]
  • Glucose tolerance per blood samples [Срок оценки: From enrollment to the end of treatment at week 5]
  • Triglycerides per blood samples [Срок оценки: From enrollment to the end of treatment at week 5]
  • Cholesterol per blood samples [Срок оценки: From enrollment to the end of treatment at week 5]
  • C peptide per blood samples [Срок оценки: From enrollment to the end of treatment at week 5]
  • Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versions [Срок оценки: From enrollment to the end of treatment at week 5]
  • Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire [Срок оценки: From enrollment to the end of treatment at week 5]
  • Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scale [Срок оценки: From enrollment to the end of treatment at week 5]
  • Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A) [Срок оценки: From enrollment to the end of treatment at week 5]
  • Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items [Срок оценки: From enrollment to the end of treatment at week 5]

Критерии участия

Критерии включения

  • Being English-proficient
  • Ages 11-14
  • At or above the 85th BMI percentile based on age and sex norms
  • Having access to WIFI or cellular data to attend the telehealth groups
  • Living in a home in Lubbock County (TX) or surrounding areas.

Критерии исключения

  • Having a psychiatric or medical diagnosis that interferes with participation (e.g., significant developmental delay; pregnancy)
  • Current enrollment in overweight/obesity treatment.
  • Because the study will include entering an MRI scanner, additional standard exclusion criteria will be considered (e.g., having immovable medical devices with batteries, body piercings on the head/face, and having substantial visual impairment that cannot be corrected with staff-provided glasses)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Texas Tech University — Lubbock

Идентификаторы

NCT: NCT06755827 · 25-0493 · U24DK132740

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗