Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Participant Burden
研究概览
简要总结
The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi.
详细描述
The study is designed based on the multiphase optimization strategy (MOST), which includes three phases to prepare or screen, optimize, and evaluate multiple components of an intervention. During first optimization phase, study team will conduct essential component selection by pilot testing three common strategies used in healthcare settings to deliver structural and psychosocial interventions that address diet behaviors. The second optimization phase will include pilot testing to examine the optimization of delivery mode for the essential components identified in first phase. In each phase, participants between 25 to 50 years of age who are at risk for CVD-related premature mortality will be recruited to complete a 3-month intervention in a community based clinical setting in Mississippi. The proposed project will provide foundational knowledge for components and delivery models that are the most essential and cost-effective to improve dietary behaviors among racial/ethnic minority and disadvantaged background populations in Mississippi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 to 50 years of age
- •cardiovascular disease-related premature mortality risk (people living with HIV/AIDS or diagnosed with or familial risk for diabetes, hypertension, obesity, or Metabolic syndrome)
- •internet access
- •Jackson (Mississippi) metropolitan statistical area residency
排除标准
- •cancer with active treatment
- •chronic obstructive pulmonary disorder, emphysema, cystic fibrosis or any other major lung disease
- •liver or kidney dysfunction, end-stage renal disease, active hepatitis,
- •celiac disease, colitis, or other gastrointestinal disorders
- •current pregnancy or within six months postpartum at baseline
- •heavy drinking
- •unintentional weight loss of more than 5% of body weight within the past six months
- •recent (in the past 6 months) heart attack, stroke or other major heart surgery or event
- •eating disorders (anorexia or bulimia nervosa)
- •currently being treated for a fungus, bacteria, viral, or other infection due to weak immune system
- •Insulin dependent diabetes
结局指标
主要结局
Participant Burden
时间窗: up to 12 weeks
An existing validated tool designed to assess research participant burden (Lingler et al., 2014) for cultural and contextual appropriateness; the tool includes 21 items assessed on a 5-point Likert agreement scale and the final adapted items will be summed for a total score. Higher scores mean a worse outcome.
次要结局
- cost effectiveness(3 months)
- session attendance(3 months)
- diet quality(up to 3 months)