Circadian Intervention to Improve Cardiometabolic Health
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: Circadian Intervention.
- Кому может быть актуально
- Состояния в реестре: Cardiometabolic Syndrome, Type 2 Diabetes, Sleep, Time Restricted Feeding. Базовые параметры: 18 лет — 45 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
Timing of Circadian Synchronizers: The TOCS Study
Обзор
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Подробное описание
The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for \~8 weeks. Both groups will have equal contact time with the study team.
Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.
Вмешательства
- Поведенческое Circadian Intervention
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Первичные конечные точки
- Insulin sensitivity change from baseline [Срок оценки: Change from baseline to end of the ~8 week experimental segment]
Вторичные конечные точки (7)
- Timing of central circadian clock change from baseline [Срок оценки: Change from baseline to end of the ~8 week experimental segment]
- Plasma ceramides change from baseline [Срок оценки: Change from baseline to end of the ~8 week experimental segment]
- Average (per week) nightly total sleep time change from baseline [Срок оценки: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) sleep satisfaction change from baseline [Срок оценки: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) self-reported sleep duration change from baseline [Срок оценки: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) timing of food intake change from baseline [Срок оценки: Change from baseline to week 8 of the ~8 week experimental segment]
- Average (per week) daytime alertness change from baseline [Срок оценки: Analyzed as change from baseline for each week of the ~8 week experimental segment]
Критерии участия
Критерии включения
- Age: 18-45 years old; equal numbers of men and women
- Body mass index (BMI): 25.0-34.9 kg/m2,
- Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months
Критерии исключения
- Clinically diagnosed sleep disorder or major psychiatric illness
- Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
- Use of prescription drugs or substances known to influence sleep or glucose metabolism
- Shift-work: current or history of within last year
- Weight change: >10% of body weight over prior six months
- Experiencing menopause or post-menopausal
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently pregnant or planning to become pregnant, or currently lactating.
- Currently smoking
- Alcohol intake >3 drinks per day or >14 drinks per week
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
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- College of Health Research Complex--University of Utah — Salt Lake City
Идентификаторы
NCT: NCT05943626 · 22-60