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临床试验/NCT05208671
NCT05208671已完成不适用

Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 675 人开始时间: 2020年10月9日最近更新:
适应症
干预措施

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

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

Experimental

12-week food assistance with low Dietary Inflammatory Index (DII) foods

干预措施: NOURISH Food Box (Other)

Wait-list Control

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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