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

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: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Diabetes, Gestational
• Intervention / Treatment: Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of any recommended postpartum diabetes screening test.	Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)	4-52 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	4-52 weeks postpartum

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kaiser Foundation Research Institute
• Investigators: Principal Investigator: Susan D Brown, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Gestational Diabetes; Health Communication; Preventive Health Services; Diabetes Mellitus, Type 2 Prevention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational
• Other Study ID 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