Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 2
- 主要终点
- Change from baseline insulin sensitivity at 12-weeks
研究概览
简要总结
The NOURISH-OK Study will identify how food insecurity contributes to insulin resistance, an important surrogate marker of many co-morbidities in HIV disease, using an integrated framework to identify key leverage points for insulin resistance. Drawing from these pathways, this study will adapt and evaluate a community-driven, science-informed "food as medicine" intervention designed to lower insulin resistance through healthy food access, food utilization skills, and other self-care behaviors. Knowledge gained from this study can benefit those living with HIV through the prevention and more effective management of pre-diabetes, diabetes, obesity, and non-alcoholic fatty liver disease.
详细描述
The community-based participatory research study will be conducted in Oklahoma, and include HIV-positive individuals living in urban and rural communities. The first two aims are observational, the third aim will test an intervention.
Aim 1: Test and refine a conceptual integrated framework of food insecurity and insulin resistance to identify significant structural, social, behavioral, and biological pathways as candidate intervention points. This aim will be accomplished using a cross-sectional survey (n=410 final sample size) and a one-month observational sub-study from the main study sample (n=89 final sample size) to collect intensive measures of dietary intake and gut microbiome samples.
Aim 2: Adapt a home-delivered grocery and cooking self-care NOURISH-OK intervention to address key nutrition disparities and other health risk behaviors identified as significant path contributors to insulin resistance among people living with HIV. This aim will be achieved through a series of interviews and focus groups with people living with HIV who are food insecure (n=45 qualitative study subjects, including interviews and focus groups).
Aim 3: Implement the 12-week NOURISH-OK intervention and assess it for feasibility, acceptability, and preliminary impact using a randomized wait-list control design (n=234). This study will use a simple randomized wait-list control trial design. Additionally, the investigators will invite a random selection from the main study sample (n=80) to participate in more intensive data collection, including multiple 24-hr food recalls and stool samples during the intervention period to assess for food insecurity, dietary, and gut microbiome changes throughout the intervention periods.
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
- •HIV-positive with income <400% federal poverty level
- •at least 1 risk factor for insulin resistance per the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (i.e., overweight/obesity, age 45 yrs or older, immediate family member with diabetes, non-white race, physical inactivity, history of gestational diabetes, history of heart disease or stroke, diagnosis of polycystic ovarian syndrome, high blood pressure, high cholesterol, or hepatitis C virus antibody positivity
- •using antiretroviral therapy for at least 6 months
- •English-speaking
排除标准
- •participating in another health-related research study
- •receiving treatment for a terminal or other serious illness, such as cancer or end-stage renal failure
- •plan to move outside of Oklahoma during the study period
- •does not have an address that can accept home-delivered groceries
研究组 & 干预措施
NOURISH Food Box
12-week food assistance with low Dietary Inflammatory Index (DII) foods
干预措施: NOURISH Food Box (Other)
Wait-list Control
Wait-list control group eligible to receive NOURISH box after study period
结局指标
主要结局
Change from baseline insulin sensitivity at 12-weeks
时间窗: Baseline; 12-weeks
Quantitative Insulin-Sensitivity Check Index (QUICKI)
次要结局
- Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks(Baseline; 6-weeks; 12-weeks; 16-weeks)
- Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks(Baseline; 6-weeks; 12-weeks; 16-weeks)
- Change from baseline skin carotenoid at 12-weeks(Baseline; 12-weeks)
- Change from baseline chronic inflammation at 12-weeks(Baseline; 12-weeks)
