SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
To determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid
- •Patients must be diagnosed with at least one of the following diseases: hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease and/or metabolic syndrome
- •Patients must at least 18 years of age or older at the time of signing consent
- •Patient must have access to internet-enabled device
- •Patient has no objections to online grocery shopping, home food deliveries, or nutrition counseling
- •Patient lives in setting able to receive Instacart deliveries (e.g., non-institutionalized)
- •Patient is willing to use a credit card for Instacart back-up payments
排除标准
- •Have any condition that impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.)
- •Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption)
- •Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
- •Any other factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study
- •Recent (e.g., 6 months) participation in other behavioral nutrition trials
- •Are currently pregnant or are planning to become pregnant during the study
结局指标
主要结局
Enrollment
时间窗: Week 1
Enrollment will be determined by the percent of eligible participants who enroll in the study.
Adherence - Mid-Ohio Farmacy
时间窗: 24 weeks
Adherence will be determined based on the number of visits to food pantries divided by the total number of possible visits.
Adherence - Health Impact Ohio
时间窗: 24 weeks
Adherence to the Health Impact Ohio component of the intervention to address social needs will be determined based on the percent of participants that enroll with the community health worker.
Adherence - Behavioral Nutritional Counseling
时间窗: 16 weeks
Adherence to behavioral nutritional counseling will be determined by the number of interactions with behavioral counseling out of the total number of counseling sessions offered.
Retention
时间窗: 24 weeks
The percent of participants that complete the study visits at 12 and 24 weeks.
Engagement
时间窗: 8 weeks
Engagement will be determined by the amount of total dollars spent on Instacart per participant.
次要结局
- Nutrition Security(24 weeks)
- Dietary Patterns(24 weeks)
- Cardiometabolic Health(24 weeks)
- Purchasing Behavior(24 weeks)
研究者
Joshua Joseph, MD
Principal Investigator
Ohio State University