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OpenTrials
Enrolling by Invitation

NCT Number: NCT05752292

Study to Understand Risk Information to Support and Empower

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.

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Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Completion of any recommended postpartum diabetes screening test.

    Time frame: 4-52 weeks postpartum

    Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)

  2. Completion of any recommended postpartum diabetes screening test.

    Time frame: 4-12 weeks postpartum

    Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)

  3. Uptake of a lifestyle program for diabetes prevention.

    Time frame: 4-52 weeks postpartum

    Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Kaiser Foundation Research Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: SUNRISE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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