Study to Understand Risk Information to Support and Empower

Part of paid clinical trials in Pleasanton, California.

Sponsor
University of California, Davis
Study ID
NCT05752292
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Health Information — BEHAVIORAL
    Standard health information about postpartum screening and lifestyle programs for diabetes prevention
  • Values Affirmation (VA) — BEHAVIORAL
    Interactive prompts to reflect on core personal values
  • Tailored Risk Information (TRI) — BEHAVIORAL
    Interactive prompts to provide tailored information on risk factors for type 2 diabetes
  • Motivational Interviewing-based (MI) — BEHAVIORAL
    Interactive prompts based on principles of motivational interviewing
  • Action planning (AP) — BEHAVIORAL
    Interactive prompts to problem solve challenges

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Condition 1
    Standard health message + VA + TRI + MI+ AP
  • Experimental: Condition 2
    Standard health message + VA + TRI + MI
  • Experimental: Condition 3
    Standard health message + VA + TRI + AP
  • Experimental: Condition 4
    Standard health message + VA + TRI
  • Experimental: Condition 5
    Standard health message + VA + MI+ AP
  • Experimental: Condition 6
    Standard health message + VA + MI
  • Experimental: Condition 7
    Standard health message + VA + AP
  • Experimental: Condition 8
    Standard health message + VA
  • Experimental: Condition 9
    Standard health message + TRI + MI+ AP
  • Experimental: Condition 10
    Standard health message + TRI + MI
  • Experimental: Condition 11
    Standard health message + TRI + AP
  • Experimental: Condition 12
    Standard health message + TRI
  • Experimental: Condition 13
    Standard health message + MI+ AP
  • Experimental: Condition 14
    Standard health message + MI
  • Experimental: Condition 15
    Standard health message + AP
  • Experimental: Condition 16
    Standard health message

Primary Outcome Measure

Completion of recommended postpartum diabetes screening. [ Time Frame: 4-12 weeks postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern CaliforniaPleasantonCalifornia94588-

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