Меню
Набор скоро начнётся NCT07631767

Shift Workers' Health Behavior Action Program Across Europe

Без фазы С лечением Night Shift Work Obesity & Overweight Circadian Misalignment

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: Combined Lifestyle Intervention.
Кому может быть актуально
Состояния в реестре: Night Shift Work, Obesity & Overweight, Circadian Misalignment. Базовые параметры: от 21 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
Германия, Нидерланды, Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study evaluates the effects of a Combined Lifestyle Intervention Program (CLIP) on sleep, lifestyle behaviors, obesity risk and health in night-shift workers. The primary objective is to assess the effect of the CLIP on objectively measured sleep duration. Secondary objectives include behavioral outcomes related to sleep, diet, physical activity, and stress, as well as body weight and metabolic outcomes, . It is hypothesized that CLIP participants will show a greater increase in sleep duration than controls, alongside favorable changes in lifestyle and health outcomes.

Вмешательства

  • Поведенческое Combined Lifestyle Intervention
    The 24-week lifestyle intervention is structured in four 6-week blocks focusing on sleep and stress management or diet and physical activity. Lifestyle advice and behavior change techniques are delivered via a mobile application, complemented by workshops.

Первичные конечные точки

  • Sleep duration [Срок оценки: From enrollment to the end of intervention (24 weeks)]
Вторичные конечные точки (12)
  • Body weight [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • BMI [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Objective sleep quality [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Overall diet quality [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Physical activity level [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Perceived stress [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Subjective sleep quality (Insomina) [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Subjective leep quality (pattern) [Срок оценки: [Time Frame: From enrollment to end of intervention (24 weeks)]]
  • Chrono-nutrition patterns [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Food preferences [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Occupational physical activity [Срок оценки: From enrollment to end of intervention (24 weeks)]
  • Work-related sense of coherence [Срок оценки: From enrollment to end of intervention (24 weeks)]

Критерии участия

Критерии включения

  • Age ≥ 21 years
  • Work ≥ 24 hours per week
  • Shift work duration > 3 years and currently doing night shifts
  • Expected to continue night shiftwork for at least 1 year after inclusion
  • On average working ≥ 4 night shifts per month
  • Working generally ≥ 2 consecutive night shifts
  • In possession of a smartphone and willing to download the study application

Критерии исключения

  • Body Mass Index (BMI) < 18.5 or > 40 kg/m2
  • Pregnant or lactating
  • Chronic diseases with ongoing therapy (e.g. renal failure, active hepatitis, cirrhosis, myocardial infarction, chronic obstructive pulmonary disease and cancer)
  • Current or recent use of medications interfering with sleep, including: Central nervous system stimulants (e.g., Ritalin, Adderall, Modafinil or similar); Chronic use of sleep agents (e.g., benzodiazepine, non-hypnotic benzodiaze-pine, first-generation antihistamine, melatonin receptors agonists or similar); Other medications or combinations significantly affecting sleeping patterns
  • Recent or ongoing psychotherapy for sleep disorders
  • Current or recent use of medications affecting appetite or weight regulation, including: Appetite-enhancing/weight-gain medications (e.g., atypical antipsychotics, cor-ticosteroids such as prednisone, mirtazapine or similar); Appetite-suppressing/weight-loss medications (e.g., CNS stimulants such as Ritalin, Adderall, GLP-1 receptors agonists or similar); Other medications or combinations significantly influencing appetite or body weight
  • Participation in another human trial, lifestyle program or weight loss intervention within the past 3 months
  • Planned surgical procedure during the study period
  • History of or planned bariatric surgery/treatment

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

Германия · 2 центра
  • Uni Bremen — Bremen
  • TTZ — Bremerhaven
Нидерланды · 2 центра
  • Erasmus Medical Centre — Rotterdam
  • Wageningen University & Research — Wageningen
Польша · 1 центр
  • Lodz — Lodz

Идентификаторы

NCT: NCT07631767 · NL-010791

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗