Diabetes, GestationalSUNRISENCT05752292

Study to Understand Risk Information to Support and Empower

A study testing Standard Health Information, Values Affirmation (VA) and Tailored Risk Information (TRI) in people with Diabetes, Gestational and Diabetes Mellitus, Type 2, run by University of California, Davis at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Diabetes, Gestational, Diabetes Mellitus, Type 2
What is being tested?: Standard Health Information, Values Affirmation (VA) and Tailored Risk Information (TRI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteUnited States
Study dates: 13 Apr 2023to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Kaiser Permanente Northern California
Pleasanton, California, 94588

Other trials in United States

About this study

Official title: 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.

Conditions: Diabetes, Gestational, Diabetes Mellitus, Type 2
Being tested: Standard Health Information, Values Affirmation (VA), Tailored Risk Information (TRI), Motivational Interviewing-based (MI), Action planning (AP)
Keywords: Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication
Medical subject headings: Diabetes, Gestational, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05752292
Study group	Role	What they receive
Condition 1	Experimental	Standard health message + VA + TRI + MI+ AP Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)
Condition 2	Experimental	Standard health message + VA + TRI + MI Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI)
Condition 3	Experimental	Standard health message + VA + TRI + AP Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Action planning (AP)
Condition 4	Experimental	Standard health message + VA + TRI Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI)
Condition 5	Experimental	Standard health message + VA + MI+ AP Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)
Condition 6	Experimental	Standard health message + VA + MI Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Motivational Interviewing-based (MI)
Condition 7	Experimental	Standard health message + VA + AP Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Action planning (AP)
Condition 8	Experimental	Standard health message + VA Receives: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA)
Condition 9	Experimental	Standard health message + TRI + MI+ AP Receives: Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)
Condition 10	Experimental	Standard health message + TRI + MI Receives: Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI)
Condition 11	Experimental	Standard health message + TRI + AP Receives: Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Action planning (AP)
Condition 12	Experimental	Standard health message + TRI Receives: Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI)
Condition 13	Experimental	Standard health message + MI+ AP Receives: Behavioral: Standard Health Information; Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)
Condition 14	Experimental	Standard health message + MI Receives: Behavioral: Standard Health Information; Behavioral: Motivational Interviewing-based (MI)
Condition 15	Experimental	Standard health message + AP Receives: Behavioral: Standard Health Information; Behavioral: Action planning (AP)
Condition 16	Experimental	Standard health message Receives: Behavioral: Standard Health Information

What is being measured

The primary outcome is the main question the study is designed to answer.

Completion of recommended postpartum diabetes screening.
Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)
Measured: 4-12 weeks postpartum

Secondary outcomes (3)

Completion of any recommended postpartum diabetes screening test.
Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)
Measured: 4-52 weeks postpartum
Completion of any recommended postpartum diabetes screening test.
Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)
Measured: 4-12 weeks postpartum
Uptake of a lifestyle program for diabetes prevention.
Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result
Measured: 4-52 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 2023Dec 2026

First posted2 Mar 2023
Study start13 Apr 2023
Primary completion23 Mar 2026
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05752292
Sponsor's protocol ID: 1826240
Other IDs: R01DK122087
Acronym: SUNRISE
Status last verified: Aug 2026
First submitted: 16 Feb 2023
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases

All Diabetes, Gestational trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM
ClinicalTrials.gov ID: NCT05752292
Acronym / sponsor ID: SUNRISE / 1826240
Conditions: Diabetes, Gestational, Diabetes Mellitus, Type 2
Keywords: Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 2,000 participants (estimated)
Lead sponsor: University of California, DavisUniversity, hospital or other
Collaborators: Kaiser Foundation Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 13 Apr 2023 (actual)
Primary completion: 23 Mar 2026 (actual)
Study completion: Dec 2026 (estimated)
First posted: 2 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 16

Arm	Type	Receives
Condition 1	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Tailored Risk Information (TRI), Behavioral: Motivational Interviewing-based (MI), Behavioral: Action planning (AP)Standard health message + VA + TRI + MI+ AP
Condition 2	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Tailored Risk Information (TRI), Behavioral: Motivational Interviewing-based (MI)Standard health message + VA + TRI + MI
Condition 3	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Tailored Risk Information (TRI), Behavioral: Action planning (AP)Standard health message + VA + TRI + AP
Condition 4	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Tailored Risk Information (TRI)Standard health message + VA + TRI
Condition 5	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Motivational Interviewing-based (MI), Behavioral: Action planning (AP)Standard health message + VA + MI+ AP
Condition 6	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Motivational Interviewing-based (MI)Standard health message + VA + MI
Condition 7	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA), Behavioral: Action planning (AP)Standard health message + VA + AP
Condition 8	Experimental	Behavioral: Standard Health Information, Behavioral: Values Affirmation (VA)Standard health message + VA
Condition 9	Experimental	Behavioral: Standard Health Information, Behavioral: Tailored Risk Information (TRI), Behavioral: Motivational Interviewing-based (MI), Behavioral: Action planning (AP)Standard health message + TRI + MI+ AP
Condition 10	Experimental	Behavioral: Standard Health Information, Behavioral: Tailored Risk Information (TRI), Behavioral: Motivational Interviewing-based (MI)Standard health message + TRI + MI
Condition 11	Experimental	Behavioral: Standard Health Information, Behavioral: Tailored Risk Information (TRI), Behavioral: Action planning (AP)Standard health message + TRI + AP
Condition 12	Experimental	Behavioral: Standard Health Information, Behavioral: Tailored Risk Information (TRI)Standard health message + TRI
Condition 13	Experimental	Behavioral: Standard Health Information, Behavioral: Motivational Interviewing-based (MI), Behavioral: Action planning (AP)Standard health message + MI+ AP
Condition 14	Experimental	Behavioral: Standard Health Information, Behavioral: Motivational Interviewing-based (MI)Standard health message + MI
Condition 15	Experimental	Behavioral: Standard Health Information, Behavioral: Action planning (AP)Standard health message + AP
Condition 16	Experimental	Behavioral: Standard Health InformationStandard health message

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard Health InformationStandard health information about postpartum screening and lifestyle programs for diabetes prevention	Behavioural	Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9
Values Affirmation (VA)Interactive prompts to reflect on core personal values	Behavioural	Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8
Tailored Risk Information (TRI)Interactive prompts to provide tailored information on risk factors for type 2 diabetes	Behavioural	Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 3, Condition 4, Condition 9
Motivational Interviewing-based (MI)Interactive prompts based on principles of motivational interviewing	Behavioural	Condition 1, Condition 10, Condition 13, Condition 14, Condition 2, Condition 5, Condition 6, Condition 9
Action planning (AP)Interactive prompts to problem solve challenges	Behavioural	Condition 1, Condition 11, Condition 13, Condition 15, Condition 3, Condition 5, Condition 7, Condition 9

Primary outcome

Completion of recommended postpartum diabetes screening.
Time frame: 4-12 weeks postpartum
Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)

3 secondary outcomes

Completion of any recommended postpartum diabetes screening test.
Time frame: 4-52 weeks postpartum
Completion of any recommended postpartum diabetes screening test.
Time frame: 4-12 weeks postpartum
Uptake of a lifestyle program for diabetes prevention.
Time frame: 4-52 weeks postpartum

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.

Related trials for Diabetes, Gestational

RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Susan D Brown, PhD principal investigator

University of California, Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of recommended postpartum diabetes screening. (time frame: 4-12 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05752292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.