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Идёт набор NCT07708064

Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain

Без фазы С лечением Overweight or Obesity

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: JITAI Combined with psychological intervention, Active Control.
Кому может быть актуально
Состояния в реестре: Overweight or Obesity. Базовые параметры: 18 лет — 70 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
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Обзор

This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. Participants will be randomly assigned to one of two conditions. In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in. These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing. In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.

Вмешательства

  • Поведенческое JITAI Combined with psychological intervention
    For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm). Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections). They will take approximately 1-10 minutes. Participants will also attend an introductory workshop, during whi
  • Поведенческое Active Control
    For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles. Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.

Первичные конечные точки

  • State negative affect [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State shame [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State Motivation [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State Self-Efficacy [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • Current confidence in the effectiveness of weight control behaviors [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State self-compassion [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State mindfulness [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • State acceptance [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
  • Self-serving interpretation of weight gain [Срок оценки: Whenever participants regain weight during the 6 month study period]
  • Daily Calorie Tracking (Yes/No) [Срок оценки: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
Вторичные конечные точки (3)
  • Mindfulness (Hypothesized intervention mediator) [Срок оценки: Mid-Treatment (3 months after baseline)]
  • Acceptance (Hypothesized intervention mediator) [Срок оценки: Mid-Treatment (3 months after baseline)]
  • Self-compassion (Hypothesized intervention mediator) [Срок оценки: Mid-Treatment (3 months after baseline)]

Критерии участия

Критерии включения

  • Ages 18-70 years
  • BMI of 25-50 kg/m2
  • Current weight is 3% lower than their highest weight in the past 3 years
  • Desire to maintain their weight or lose more
  • Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
  • Smartphone and Internet access
  • Successful completion of all enrollment procedures
  • Ability to attend a workshop(s) on a Monday or Tuesday evening

Критерии исключения

  • History of bariatric surgery
  • History of being diagnosed with an eating disorder
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
  • Enrolled in another formal weight loss/weight maintenance program
  • Currently taking a GLP-1 medication.

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
  • Oregon Research Institute Community and Evaluation Services — Springfield

Идентификаторы

NCT: NCT07708064 · K01HL172254

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗