Food and Fitness With Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- GLP-1 RA discontinuation rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
干预措施: Exercise is Medicine (EIM) (Behavioral)
FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
干预措施: Culinary Education (Behavioral)
FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
干预措施: Food is Medicine (Behavioral)
FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
干预措施: Nutrition Counseling (Behavioral)
FFWM+
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
干预措施: Participant Website (Behavioral)
Standard Care
Control Group - access to optional cooking demos
结局指标
主要结局
GLP-1 RA discontinuation rates
时间窗: 0, 12, and 24 weeks
GLP-1RA discontinuation rates will be captured using the electronic medical record to obtain medication name and formulation, dosage and frequency, prescription start and end dates, prescribing provider, refill information and prescription status (active, discontinued, completed), clinic notes or medication reconciliation fields confirming ongoing use or discontinuation, pharmacy records indicating medication pick-up (when available).
次要结局
- Metabolites(0, 12, and 24 weeks)
- Life's Essential 8 Scores(0, 12, and 24 weeks)
- Hip Circumference(0, 12, and 24 weeks)
- Dermal Carotenoid Scores(0, 12, and 24 weeks)
- Blood Pressure(0, 12, and 24 weeks)
- Nutrition Security(0, 12, 24 weeks.)
- Social and Emotional Wellbeing(0, 12, and 24 weeks)
- Social Needs(0, 12, and 24 weeks)
- Waist Circumference(0, 12, and 24 weeks)
- American Heart Association (AHA) PREVENT Scores(0, 12, and 24 weeks)
- Blood Lipids(0, 12, and 24 weeks)
- Body Composition(0, 12, and 24 weeks)
- Dietary Patterns(0, 12, and 24 weeks)
- HbA1c(0, 12, and 24 weeks)
- Food Noise(0, 12, 24 and weeks)
研究者
Colleen Spees, PhD, RD, FAND, FAHA
Professor of Medical Dietetics and Director of Hope Lab
Ohio State University