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

Primary Purpose

Diabetes, Gestational, Diabetes Mellitus, Type 2

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Health Information

Values Affirmation (VA)

Tailored Risk Information (TRI)

Motivational Interviewing-based (MI)

Action planning (AP)

About this trial

This is an interventional health services research trial for Diabetes, Gestational focused on measuring Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 Pregnancy loss History of eating disorder Previously requested not to receive research invitations

Sites / Locations

Kaiser Permanente Northern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Condition 9

Condition 10

Condition 11

Condition 12

Condition 13

Condition 14

Condition 15

Condition 16

Arm Description

Standard health message + VA + TRI + MI+ AP

Standard health message + VA + TRI + MI

Standard health message + VA + TRI + AP

Standard health message + VA + TRI

Standard health message + VA + MI+ AP

Standard health message + VA + MI

Standard health message + VA + AP

Standard health message + VA

Standard health message + TRI + MI+ AP

Standard health message + TRI + MI

Standard health message + TRI + AP

Standard health message + TRI

Standard health message + MI+ AP

Standard health message + MI

Standard health message + AP

Standard health message

Outcomes

Primary Outcome Measures

Completion of recommended postpartum diabetes screening.

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

Secondary Outcome Measures

Completion of any recommended postpartum diabetes screening test.

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

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

Full Information

NCT ID

NCT05752292

First Posted

February 16, 2023

Last Updated

April 18, 2023

Sponsor

University of California, Davis

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05752292

Brief Title

Study to Understand Risk Information to Support and Empower

Acronym

SUNRISE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 13, 2023 (Actual)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Gestational, Diabetes Mellitus, Type 2

Keywords

Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Condition 1

Arm Type

Experimental

Arm Description

Standard health message + VA + TRI + MI+ AP

Arm Title

Condition 2

Arm Type

Experimental

Arm Description

Standard health message + VA + TRI + MI

Arm Title

Condition 3

Arm Type

Experimental

Arm Description

Standard health message + VA + TRI + AP

Arm Title

Condition 4

Arm Type

Experimental

Arm Description

Standard health message + VA + TRI

Arm Title

Condition 5

Arm Type

Experimental

Arm Description

Standard health message + VA + MI+ AP

Arm Title

Condition 6

Arm Type

Experimental

Arm Description

Standard health message + VA + MI

Arm Title

Condition 7

Arm Type

Experimental

Arm Description

Standard health message + VA + AP

Arm Title

Condition 8

Arm Type

Experimental

Arm Description

Standard health message + VA

Arm Title

Condition 9

Arm Type

Experimental

Arm Description

Standard health message + TRI + MI+ AP

Arm Title

Condition 10

Arm Type

Experimental

Arm Description

Standard health message + TRI + MI

Arm Title

Condition 11

Arm Type

Experimental

Arm Description

Standard health message + TRI + AP

Arm Title

Condition 12

Arm Type

Experimental

Arm Description

Standard health message + TRI

Arm Title

Condition 13

Arm Type

Experimental

Arm Description

Standard health message + MI+ AP

Arm Title

Condition 14

Arm Type

Experimental

Arm Description

Standard health message + MI

Arm Title

Condition 15

Arm Type

Experimental

Arm Description

Standard health message + AP

Arm Title

Condition 16

Arm Type

Experimental

Arm Description

Standard health message

Intervention Type

Behavioral

Intervention Name(s)

Standard Health Information

Intervention Description

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Intervention Type

Behavioral

Intervention Name(s)

Values Affirmation (VA)

Intervention Description

Interactive prompts to reflect on core personal values

Intervention Type

Behavioral

Intervention Name(s)

Tailored Risk Information (TRI)

Intervention Description

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Intervention Type

Behavioral

Intervention Name(s)

Motivational Interviewing-based (MI)

Intervention Description

Interactive prompts based on principles of motivational interviewing

Intervention Type

Behavioral

Intervention Name(s)

Action planning (AP)

Intervention Description

Interactive prompts to problem solve challenges

Primary Outcome Measure Information:

Title

Completion of recommended postpartum diabetes screening.

Description

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

Time Frame

4-12 weeks postpartum

Secondary Outcome Measure Information:

Title

Completion of any recommended postpartum diabetes screening test.

Description

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

Time Frame

4-52 weeks postpartum

Title

Uptake of a lifestyle program for diabetes prevention.

Description

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

Time Frame

4-52 weeks postpartum

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan D Brown, PhD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Northern California

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study to Understand Risk Information to Support and Empower

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