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临床试验/NCT05407376
NCT05407376已完成不适用

Produce Prescriptions At Kaiser Permanente Southern California - an Innovative 'food As Medicine' Clinical Trial to Improve Food Insecurity and Health Among Medicaid Patients with Consistently Uncontrolled Type 2 Diabetes

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
460
试验地点
2
主要终点
Change in HbA1c between baseline and 6 months

研究概览

简要总结

The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a large and diverse integrated health care system that serves 4.7 million members. Eligible participants are members aged 18 or older, currently enrolled in Medicaid who were diagnosed with diabetes for at least 24 months and had at least two Hba1c measurements of 7.5% or higher in the past 12 months. Patients in the intervention arm may enroll in tele nutrition counseling. The study team will recruit a total of 450. Participants, will be pre-randomized into one of three arms, 1) high dose intervention arm, a 2) low dose intervention and 3) a usual care group to achieve 150 participants enrolled in each arm. Produce is delivered weekly for participants of both intervention arms. Participants randomized to the high dose arm will receive a greater amount per month of produce versus the low dose amount (for a family of 3-4, $180 per month versus $135 respectively). Foods are provided along with recipes. The amount of food delivered is adjusted for each additional family member for up to 5 family members. The primary outcome is change in hemoglobin A1c pre-intervention and 6 months after enrollment. Secondary outcomes include, food insecurity status, dietary intake and other patient reported outcomes related to barriers to healthy eating including family conflict and cooking habits.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years of age or older
  • Diagnosed with Type 2 Diabetes for at least 24 months
  • Diagnosed with Type 2 Diabetes and have at least two HbA1cs of 7.5% or higher in 12 months prior to recruitment
  • Have MediCaid insurance at the time of their last hba1c test
  • Will be able to provide informed consent
  • Will be able to consent to research activities, including receiving a weekly produce box
  • Will be able to receive and prepare delivered foods

排除标准

  • Pregnant women
  • Living in a board and care where your meals are provided for you
  • Unable to provide informed consent

结局指标

主要结局

Change in HbA1c between baseline and 6 months

时间窗: Baseline and 6 months after baseline assessment

Both intervention and control participants will have their HbA1c tested at baseline and 6 months after the baseline assessment.

次要结局

  • Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.(Survey completed at Baseline, 3 months and 6 months)
  • Analyze the difference in difference of patient-reported food security between the intervention and control group.(Survey completed at Baseline, 3 months and 6 months)
  • Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.(Survey completed at Baseline, 3 months and 6 months)
  • Analyze the difference in difference of patient-reported diet quality between the intervention and control group.(Survey completed at Baseline, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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