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临床试验/NCT06311799
NCT06311799已完成不适用

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年4月29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
240
试验地点
1
主要终点
Difference in Women, Infants, and Children (WIC) enrollment

研究概览

简要总结

This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •English speaking
  • •Confirmed pregnancy
  • •Public Insurance (Medicaid) OR no insurance
  • •If no insurance, must meet income eligibility for WIC
  • •Intent to deliver at a Geisinger facility
  • •Able and willing to provide consent

排除标准

  • •Pre-existing WIC enrollment as a pregnant person
  • •Not eligible for WIC
  • •Private insurance
  • •Unwilling to participate for up to 12 months

研究组 & 干预措施

Arm 1: Clinic Model

No Intervention

Clinical team gives WIC information only

Arm 2: Clinic-WIC Model

Active Comparator

Clinical team connects patient to WIC

干预措施: WIC Referral (Behavioral)

Arm 3: Clinic-RDN Model

Active Comparator

Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)

干预措施: RDN Referral (Behavioral)

Arm 4: Clinic-WIC-RDN

Active Comparator

Clinical team connects patient to WIC and RDN

干预措施: WIC Referral (Behavioral)

Arm 4: Clinic-WIC-RDN

Active Comparator

Clinical team connects patient to WIC and RDN

干预措施: RDN Referral (Behavioral)

结局指标

主要结局

Difference in Women, Infants, and Children (WIC) enrollment

时间窗: 6 months

Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)

次要结局

  • Prenatal clinic visit adherence.(6 months)
  • WIC retention(6 months)
  • WIC adherence(6 months)
  • Registered Dietitian/Nutritionist (RDN) visit adherence(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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