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Набор по приглашению NCT06790472

Metabolic Wellness and CGM

— Наблюдательное Cardiometabolic Risk Factors

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: Online Lifestyle Intervention, Continuous Glucose Monitoring.
Кому может быть актуально
Состояния в реестре: Cardiometabolic Risk Factors. Базовые параметры: от 18 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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Официальное название

Assessing the Glycemic Impact of an Online Lifestyle Intervention Using CGM (Continuous Glucose Monitoring). a Pilot Study.

Обзор

The primary objective of this study is to determine the impact of participating in an online lifestyle intervention program on glycemic control as measured by Continuous Glucose Monitoring (CGM), with the primary outcome being the time-in-range (TIR) between 70 and 140 mg/dl comparing before the intervention, at the start of the program (week 1), and after the intervention (week 8).

Подробное описание

The Metabolic Wellness Program (MWP) is an established 8-week program that provides participants with digitally delivered health education focusing on metabolic health. The program content is based on nutrition education, promotion of physical activity, stress reduction and the need for quality sleep. The MWP also includes the use of continuous glucose monitoring (CGM), The MWP is aimed at adults with pre-existing type 2 diabetes (T2D), prediabetes and also individuals who wish to retain their metabolic health. (More information about the program is available here: https://www.sutterhealth.org/classes-events/the-metabolic-wellness-program-34466

To evaluate the success (or otherwise) of the MWP, the aim of this pilot study is to assess the impact of participating in the MWP on glycemic control, with the primary outcome being the time-in-range between 70 and 140 mg/dl measured by CGM. Data from this pilot study will provide evidence for a larger future randomized controlled trial (RCTs).

The secondary objectives are to:

* Examine additional changes in CGM variables comparing before (at baseline)and after the intervention (at week 8 and at 3 months post-intervention) Examine changes in self-reported behavior changes related to food choices, physical activity, sleep quality, and stress levels. * Examine changes in lab values (if available as part of routine clinical care from the previous 12 months and up to 6 months after the program): and * Examine engagement with the program, engagement with CGM, and satisfaction with the program

Вмешательства

  • Поведенческое Online Lifestyle Intervention
    The Metabolic Wellness Program (MWP) is an established 8-week program that provides participants with health education videos and webinars that focus on evidence-based nutrition, fitness, sleep, and stress intervention, including with CGM, allowing participants to monitor their real-time glucose data and to learn which lifestyle choices are best for their glycemic control and personal metabolic health. The program is also intended to help healthy participants maintain their metabolic health and
  • Устройство Continuous Glucose Monitoring
    CGM measurements begin at enrollment with training provided digitally Participants will be asked to "live life as usual" whilst wearing the device with initial 10-14 day readings providing baseline data. Participants will participate in the online lifestyle program, which the investigators refer to as the "intervention stage." Participants will also receive questionnaires on behavior change at the beginning of week 5. During the final two weeks of the program (weeks 7-8), the final 10-14 days of

Первичные конечные точки

  • Glycemic Control (Time-in-Range) [Срок оценки: Baseline and Weeks 2, 7-8]

Критерии участия

Критерии включения

  • Adults who are enrolled in the MWP
  • Adults ≥ 18 years of age at enrollment.
  • Willing to wear a CGM device.
  • Sutter Health employee or employee's dependent enrolled in SutterSelect Employee Medical Benefits

Критерии исключения

  • Pregnancy
  • Taking insulin
  • Chronic kidney disease and on dialysis
  • Any active clinically significant disease or disorder which, in the investigator's opinion, could interfere with participation in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Palo Alto Medical Foundation — Palo Alto

Идентификаторы

NCT: NCT06790472 · 2024.055-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗