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临床试验/NCT06329375
NCT06329375招募中不适用

Food Insecurity Reduction & Strategy Team

Stanford University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Food insecurity at 60 -days post initial discharge

研究概览

简要总结

This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:

  1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
  2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
  3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Diagnosis of Type 1 or Type 2 Diabetes Mellitus
  • Admitted to Stanford Healthcare inpatient unit
  • Residence in California at time of enrollment
  • Positive Screening for Food Insecurity
  • On a Healthcare Plan covered by Mom's Meals.

排除标准

  • Plans to be discharged to a skilled nursing facility.
  • Patients who prefer a language for which a short-form consent is not available.
  • No Home Address
  • Pregnant Participants.
  • No access to refrigerator.

研究组 & 干预措施

SoC group

No Intervention

Standard of care (SOC)

Nutrition program (Intervention)

Experimental

Patients in the intervention group will be provided the following two resources in addition to SOC:

  1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge).
  2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options.

干预措施: Nutrition program (Other)

结局指标

主要结局

Food insecurity at 60 -days post initial discharge

时间窗: 60 days from discharge

Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire. 1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical) a. Never true, Sometimes true, Often true, Patient refused 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical) 1. Never true, Sometimes true, Often true, Patient refused

次要结局

  • Food insecurity at 30- and 90- days post post initial discharge(30-, and 90- days from discharge)
  • Measures of diabetes stress(30-,60-, and 90- days from discharge)
  • Measures of hypoglycemia(30-,60-, and 90- days from discharge)
  • Measures of medication adherence(30-,60-, and 90- days from discharge)
  • Hospitalization(30-,60-, and 90- days from discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neera Ahuja

Professor of Medicine, Associate Chief Medical Officer- Inpatient Care Services, Division Chief- Hospital Medicine

Stanford University

研究点 (1)

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