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临床试验/NCT05752292
NCT05752292Enrolling By Invitation不适用

Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM

University of California, Davis1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,000
试验地点
1
主要终点
Completion of recommended postpartum diabetes screening.

研究概览

简要总结

The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Current pregnancy complicated by gestational diabetes mellitus (GDM)
  • Age: 18 years and older
  • Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center
  • Able to communicate in English

排除标准

  • Diagnosis of diabetes before pregnancy
  • Maternal or infant current hospitalization
  • Pregnancy loss
  • History of eating disorder
  • Previously requested not to receive research invitations

研究组 & 干预措施

Condition 1

Experimental

Standard health message + VA + TRI + MI+ AP

干预措施: Values Affirmation (VA) (Behavioral)

Condition 1

Experimental

Standard health message + VA + TRI + MI+ AP

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 1

Experimental

Standard health message + VA + TRI + MI+ AP

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 2

Experimental

Standard health message + VA + TRI + MI

干预措施: Standard Health Information (Behavioral)

Condition 4

Experimental

Standard health message + VA + TRI

干预措施: Values Affirmation (VA) (Behavioral)

Condition 4

Experimental

Standard health message + VA + TRI

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 6

Experimental

Standard health message + VA + MI

干预措施: Standard Health Information (Behavioral)

Condition 6

Experimental

Standard health message + VA + MI

干预措施: Values Affirmation (VA) (Behavioral)

Condition 6

Experimental

Standard health message + VA + MI

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 7

Experimental

Standard health message + VA + AP

干预措施: Standard Health Information (Behavioral)

Condition 10

Experimental

Standard health message + TRI + MI

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 11

Experimental

Standard health message + TRI + AP

干预措施: Standard Health Information (Behavioral)

Condition 11

Experimental

Standard health message + TRI + AP

干预措施: Action planning (AP) (Behavioral)

Condition 12

Experimental

Standard health message + TRI

干预措施: Standard Health Information (Behavioral)

Condition 13

Experimental

Standard health message + MI+ AP

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 13

Experimental

Standard health message + MI+ AP

干预措施: Action planning (AP) (Behavioral)

Condition 14

Experimental

Standard health message + MI

干预措施: Standard Health Information (Behavioral)

Condition 14

Experimental

Standard health message + MI

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 15

Experimental

Standard health message + AP

干预措施: Standard Health Information (Behavioral)

Condition 15

Experimental

Standard health message + AP

干预措施: Action planning (AP) (Behavioral)

Condition 16

Experimental

Standard health message

干预措施: Standard Health Information (Behavioral)

Condition 5

Experimental

Standard health message + VA + MI+ AP

干预措施: Standard Health Information (Behavioral)

Condition 5

Experimental

Standard health message + VA + MI+ AP

干预措施: Values Affirmation (VA) (Behavioral)

Condition 5

Experimental

Standard health message + VA + MI+ AP

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 1

Experimental

Standard health message + VA + TRI + MI+ AP

干预措施: Standard Health Information (Behavioral)

Condition 10

Experimental

Standard health message + TRI + MI

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 9

Experimental

Standard health message + TRI + MI+ AP

干预措施: Action planning (AP) (Behavioral)

Condition 9

Experimental

Standard health message + TRI + MI+ AP

干预措施: Standard Health Information (Behavioral)

Condition 3

Experimental

Standard health message + VA + TRI + AP

干预措施: Action planning (AP) (Behavioral)

Condition 1

Experimental

Standard health message + VA + TRI + MI+ AP

干预措施: Action planning (AP) (Behavioral)

Condition 7

Experimental

Standard health message + VA + AP

干预措施: Values Affirmation (VA) (Behavioral)

Condition 5

Experimental

Standard health message + VA + MI+ AP

干预措施: Action planning (AP) (Behavioral)

Condition 3

Experimental

Standard health message + VA + TRI + AP

干预措施: Values Affirmation (VA) (Behavioral)

Condition 3

Experimental

Standard health message + VA + TRI + AP

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 4

Experimental

Standard health message + VA + TRI

干预措施: Standard Health Information (Behavioral)

Condition 2

Experimental

Standard health message + VA + TRI + MI

干预措施: Values Affirmation (VA) (Behavioral)

Condition 2

Experimental

Standard health message + VA + TRI + MI

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 2

Experimental

Standard health message + VA + TRI + MI

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 3

Experimental

Standard health message + VA + TRI + AP

干预措施: Standard Health Information (Behavioral)

Condition 9

Experimental

Standard health message + TRI + MI+ AP

干预措施: Motivational Interviewing-based (MI) (Behavioral)

Condition 10

Experimental

Standard health message + TRI + MI

干预措施: Standard Health Information (Behavioral)

Condition 11

Experimental

Standard health message + TRI + AP

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 7

Experimental

Standard health message + VA + AP

干预措施: Action planning (AP) (Behavioral)

Condition 8

Experimental

Standard health message + VA

干预措施: Standard Health Information (Behavioral)

Condition 8

Experimental

Standard health message + VA

干预措施: Values Affirmation (VA) (Behavioral)

Condition 9

Experimental

Standard health message + TRI + MI+ AP

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 12

Experimental

Standard health message + TRI

干预措施: Tailored Risk Information (TRI) (Behavioral)

Condition 13

Experimental

Standard health message + MI+ AP

干预措施: Standard Health Information (Behavioral)

结局指标

主要结局

Completion of recommended postpartum diabetes screening.

时间窗: 4-12 weeks postpartum

Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)

次要结局

  • Completion of any recommended postpartum diabetes screening test.(4-52 weeks postpartum)
  • Uptake of a lifestyle program for diabetes prevention.(4-52 weeks postpartum)
  • Completion of any recommended postpartum diabetes screening test.(4-12 weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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