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Clinical Trials/NCT05752292
NCT05752292
Enrolling By Invitation
Not Applicable

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

University of California, Davis1 site in 1 country2,000 target enrollmentApril 13, 2023

Overview

Phase
Not Applicable
Intervention
Standard Health Information
Conditions
Diabetes, Gestational
Sponsor
University of California, Davis
Enrollment
2000
Locations
1
Primary Endpoint
Completion of recommended postpartum diabetes screening.
Status
Enrolling By Invitation
Last Updated
last month

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2023
End Date
July 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

Condition 8

Standard health message + VA

Intervention: Standard Health Information

Condition 8

Standard health message + VA

Intervention: Values Affirmation (VA)

Condition 5

Standard health message + VA + MI+ AP

Intervention: Standard Health Information

Condition 5

Standard health message + VA + MI+ AP

Intervention: Values Affirmation (VA)

Condition 5

Standard health message + VA + MI+ AP

Intervention: Motivational Interviewing-based (MI)

Condition 5

Standard health message + VA + MI+ AP

Intervention: Action planning (AP)

Condition 1

Standard health message + VA + TRI + MI+ AP

Intervention: Standard Health Information

Condition 1

Standard health message + VA + TRI + MI+ AP

Intervention: Values Affirmation (VA)

Condition 1

Standard health message + VA + TRI + MI+ AP

Intervention: Tailored Risk Information (TRI)

Condition 1

Standard health message + VA + TRI + MI+ AP

Intervention: Motivational Interviewing-based (MI)

Condition 1

Standard health message + VA + TRI + MI+ AP

Intervention: Action planning (AP)

Condition 2

Standard health message + VA + TRI + MI

Intervention: Standard Health Information

Condition 2

Standard health message + VA + TRI + MI

Intervention: Values Affirmation (VA)

Condition 2

Standard health message + VA + TRI + MI

Intervention: Tailored Risk Information (TRI)

Condition 2

Standard health message + VA + TRI + MI

Intervention: Motivational Interviewing-based (MI)

Condition 3

Standard health message + VA + TRI + AP

Intervention: Standard Health Information

Condition 3

Standard health message + VA + TRI + AP

Intervention: Values Affirmation (VA)

Condition 3

Standard health message + VA + TRI + AP

Intervention: Tailored Risk Information (TRI)

Condition 3

Standard health message + VA + TRI + AP

Intervention: Action planning (AP)

Condition 4

Standard health message + VA + TRI

Intervention: Standard Health Information

Condition 4

Standard health message + VA + TRI

Intervention: Values Affirmation (VA)

Condition 4

Standard health message + VA + TRI

Intervention: Tailored Risk Information (TRI)

Condition 6

Standard health message + VA + MI

Intervention: Standard Health Information

Condition 6

Standard health message + VA + MI

Intervention: Values Affirmation (VA)

Condition 6

Standard health message + VA + MI

Intervention: Motivational Interviewing-based (MI)

Condition 7

Standard health message + VA + AP

Intervention: Standard Health Information

Condition 7

Standard health message + VA + AP

Intervention: Values Affirmation (VA)

Condition 7

Standard health message + VA + AP

Intervention: Action planning (AP)

Condition 9

Standard health message + TRI + MI+ AP

Intervention: Standard Health Information

Condition 9

Standard health message + TRI + MI+ AP

Intervention: Tailored Risk Information (TRI)

Condition 9

Standard health message + TRI + MI+ AP

Intervention: Motivational Interviewing-based (MI)

Condition 9

Standard health message + TRI + MI+ AP

Intervention: Action planning (AP)

Condition 10

Standard health message + TRI + MI

Intervention: Standard Health Information

Condition 10

Standard health message + TRI + MI

Intervention: Tailored Risk Information (TRI)

Condition 10

Standard health message + TRI + MI

Intervention: Motivational Interviewing-based (MI)

Condition 11

Standard health message + TRI + AP

Intervention: Standard Health Information

Condition 11

Standard health message + TRI + AP

Intervention: Tailored Risk Information (TRI)

Condition 11

Standard health message + TRI + AP

Intervention: Action planning (AP)

Condition 12

Standard health message + TRI

Intervention: Standard Health Information

Condition 12

Standard health message + TRI

Intervention: Tailored Risk Information (TRI)

Condition 13

Standard health message + MI+ AP

Intervention: Standard Health Information

Condition 13

Standard health message + MI+ AP

Intervention: Motivational Interviewing-based (MI)

Condition 13

Standard health message + MI+ AP

Intervention: Action planning (AP)

Condition 14

Standard health message + MI

Intervention: Standard Health Information

Condition 14

Standard health message + MI

Intervention: Motivational Interviewing-based (MI)

Condition 15

Standard health message + AP

Intervention: Standard Health Information

Condition 15

Standard health message + AP

Intervention: Action planning (AP)

Condition 16

Standard health message

Intervention: Standard Health Information

Outcomes

Primary Outcomes

Completion of recommended postpartum diabetes screening.

Time Frame: 4-12 weeks postpartum

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

Secondary Outcomes

  • 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)

Study Sites (1)

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