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Идёт набор NCT07027995

Food and Fitness With Medicine (FFWM)

Без фазы С лечением Cardiovascular Kidney Metabolic Syndrome Type 2 Diabetes

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: Exercise is Medicine (EIM), Culinary Education, Food is Medicine, Nutrition Counseling.
Кому может быть актуально
Состояния в реестре: Cardiovascular Kidney Metabolic Syndrome, Type 2 Diabetes. Базовые параметры: от 18 лет · Женщины.
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

Food and Fitness With Medicine

Обзор

Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to weight loss and cardiovascular health (CVH) including dermal carotenoids, body composition and metabolite biomarkers.

Вмешательства

  • Поведенческое Exercise is Medicine (EIM)
    During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
  • Поведенческое Culinary Education
    During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
  • Поведенческое Food is Medicine
    During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
  • Поведенческое Nutrition Counseling
    During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
  • Поведенческое Participant Website
    During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.

Первичные конечные точки

  • GLP-1 RA discontinuation rates [Срок оценки: 0, 12, and 24 weeks]
Вторичные конечные точки (12)
  • American Heart Association (AHA) PREVENT Scores [Срок оценки: 0, 12, and 24 weeks]
  • Metabolites [Срок оценки: 0, 12, and 24 weeks]
  • Life's Essential 8 Scores [Срок оценки: 0, 12, and 24 weeks]
  • Blood Lipids [Срок оценки: 0, 12, and 24 weeks]
  • Body Composition [Срок оценки: 0, 12, and 24 weeks]
  • Dietary Patterns [Срок оценки: 0, 12, and 24 weeks]
  • Hip Circumference [Срок оценки: 0, 12, and 24 weeks]
  • Dermal Carotenoid Scores [Срок оценки: 0, 12, and 24 weeks]
  • Blood Pressure [Срок оценки: 0, 12, and 24 weeks]
  • Nutrition Security [Срок оценки: 0, 12, 24 weeks.]
  • Social and Emotional Wellbeing [Срок оценки: 0, 12, and 24 weeks]
  • Social Needs [Срок оценки: 0, 12, and 24 weeks]

Критерии участия

Критерии включения

  • Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome.
  • At least 18 years of age at the time of signing consent.
  • Participants must have reliable transportation to attend Exercise is Medicine sessions.
  • Access to an internet-enabled device.
  • No objections to online grocery shopping, home food deliveries, or nutrition counseling.
  • Residence meets Instacart delivery requirements (e.g., non-institutionalized).
  • Participant is willing to use a personal credit card for Instacart back-up payments.
  • Participants must speak English to be able to consent and engage in FIM and EIM programs.
  • Participant has been clinically prescribed GLP-1RA's.

Критерии исключения

  • Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.).
  • Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team.
  • Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.).
  • Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption).
  • Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s.
  • Renal impairment, eGFR < 60 ml/min/1.73m2
  • Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study.
  • Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs).
  • Currently pregnant or planning to become pregnant during the study.
  • Participant is not willing to provide a urine, blood, or stool sample.

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
Поддерживающая терапия

Центры проведения

США · 4 центра
  • Ohio State Healthy Community Center — Columbus
  • Ohio State East Hospital — Columbus
  • Martha Morehouse — Columbus
  • Ohio State Outpatient Care Upper Arlington — Upper Arlington

Идентификаторы

NCT: NCT07027995 · STUDY20250193

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗