Study to Understand Risk Information to Support and Empower (SUNRISE)

August 14, 2026 updated by: University of California, Davis

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Condition 1
Standard health message + VA + TRI + MI+ AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 2
Standard health message + VA + TRI + MI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Experimental: Condition 3
Standard health message + VA + TRI + AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 4
Standard health message + VA + TRI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Experimental: Condition 5
Standard health message + VA + MI+ AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 6
Standard health message + VA + MI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Experimental: Condition 7
Standard health message + VA + AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 8
Standard health message + VA
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Values Affirmation (VA)
Interactive prompts to reflect on core personal values
Experimental: Condition 9
Standard health message + TRI + MI+ AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 10
Standard health message + TRI + MI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Experimental: Condition 11
Standard health message + TRI + AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 12
Standard health message + TRI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Tailored Risk Information (TRI)
Interactive prompts to provide tailored information on risk factors for type 2 diabetes
Experimental: Condition 13
Standard health message + MI+ AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 14
Standard health message + MI
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Motivational Interviewing-based (MI)
Interactive prompts based on principles of motivational interviewing
Experimental: Condition 15
Standard health message + AP
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention
Behavioral: Action planning (AP)
Interactive prompts to problem solve challenges
Experimental: Condition 16
Standard health message
Behavioral: Standard Health Information
Standard health information about postpartum screening and lifestyle programs for diabetes prevention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion of recommended postpartum diabetes screening.
Time Frame: 4-12 weeks postpartum
Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)
4-12 weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
4-52 weeks postpartum
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
4-52 weeks postpartum
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)
4-12 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kaiser Foundation Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan D Brown, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1826240
  • R01DK122087 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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