Online Intervention for Gestational Diabetes Postpartum Care

(SUNRISE Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Diabetes before pregnancy, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve postpartum care for individuals who had gestational diabetes (GDM) during pregnancy. It tests an online program that provides helpful health information and uses techniques like motivational interviewing (a counseling approach) and personalized risk information to encourage participation in diabetes prevention activities after childbirth. The trial compares different combinations of these techniques to identify the most effective approach. It is ideal for those who experienced GDM, speak English, and are part of the Kaiser Permanente Northern California network. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance postpartum health care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the digital health program tested in this trial includes methods such as Action Planning, Motivational Interviewing, Tailored Risk Information, and Values Affirmation. Although specific safety data from past studies is lacking, these methods are generally safe and widely used in healthcare.

Action Planning, while lacking specific safety data, commonly helps patients manage conditions like gestational diabetes by setting clear goals and steps.

Motivational Interviewing is a well-known technique that boosts motivation to change behavior. Studies have found it effective and safe for helping women with gestational diabetes become more active.

Tailored Risk Information provides patients with personalized health details. Although specific safety data isn't available, this approach regularly helps patients understand their health risks and take preventive steps.

Values Affirmation involves reflecting on personal values to encourage positive changes, such as increased interest in preventing diabetes. Research shows it is practical and well-accepted in healthcare.

Overall, these methods are well-integrated into healthcare and considered safe. Participants can feel confident knowing these strategies have been used successfully and safely in similar settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for managing postpartum care in gestational diabetes. Traditional treatments often focus on medication and dietary changes during pregnancy. This trial, however, examines how psychological and behavioral strategies like action planning, motivational interviewing, tailored risk information, and values affirmation can be integrated into online interventions. These approaches aim to empower mothers with personalized, actionable tools to maintain healthy habits after childbirth. By shifting the focus to mental and behavioral support, this trial could pave the way for more holistic postpartum care strategies, addressing both physical and mental health needs.

What evidence suggests that this trial's treatments could be effective for gestational diabetes postpartum care?

Research shows that certain strategies can help women who had gestational diabetes improve their health after giving birth. In this trial, researchers will assign participants to different treatment arms to evaluate these strategies. Action planning (AP), one of the strategies tested, helps participants reach weight goals and lower diabetes risk. Motivational interviewing (MI) encourages more physical activity and supports lifestyle changes, which are important for preventing diabetes. Tailored risk information (TRI) helps women understand their personal risk, motivating them to take preventive steps after pregnancy. Studies on values affirmation (VA) suggest it boosts interest in lifestyle programs, aiding in diabetes prevention. Together, these methods aim to overcome obstacles and encourage women to participate in diabetes prevention care after childbirth. ^{5 6 7 8 9}

Who Is on the Research Team?

Susan D Brown, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for pregnant individuals aged 18 or older with gestational diabetes, who speak English and are in contact with the Kaiser Permanente Northern California's perinatal service. It excludes those currently hospitalized, with pregnancy loss, prior requests to avoid research invites, eating disorders, or pre-pregnancy diabetes.

Inclusion Criteria

You are currently pregnant and have gestational diabetes.

You have been in touch with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center.

Able to communicate in English

Exclusion Criteria

You were diagnosed with diabetes before getting pregnant.

The mother or baby is currently staying in the hospital.

You have a history of an eating disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention

4-12 weeks

Online interaction

Follow-up

Participants are monitored for completion of recommended postpartum diabetes screening and uptake of lifestyle programs

4-52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Action planning (AP)
• Motivational Interviewing-based (MI)
• Standard Health Information
• Tailored Risk Information (TRI)
• Values Affirmation (VA)

Trial Overview

The study tests a digital health program designed to encourage postpartum screening and lifestyle changes for diabetes prevention. Participants receive standard health info plus up to four additional components like motivational interviewing and action planning using an interactive online platform.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 4 Interventions

Standard health message + TRI + MI+ AP

Group II: Condition 8 Experimental Treatment 2 Interventions

Standard health message + VA

Group III: Condition 7 Experimental Treatment 3 Interventions

Standard health message + VA + AP

Group IV: Condition 6 Experimental Treatment 3 Interventions

Standard health message + VA + MI

Group V: Condition 5 Experimental Treatment 4 Interventions

Standard health message + VA + MI+ AP

Group VI: Condition 4 Experimental Treatment 3 Interventions

Standard health message + VA + TRI

Group VII: Condition 3 Experimental Treatment 4 Interventions

Standard health message + VA + TRI + AP

Group VIII: Condition 2 Experimental Treatment 4 Interventions

Standard health message + VA + TRI + MI

Group IX: Condition 16 Experimental Treatment 1 Intervention

Standard health message

Group X: Condition 15 Experimental Treatment 2 Interventions

Standard health message + AP

Group XI: Condition 14 Experimental Treatment 2 Interventions

Standard health message + MI

Group XII: Condition 13 Experimental Treatment 3 Interventions

Standard health message + MI+ AP

Group XIII: Condition 12 Experimental Treatment 2 Interventions

Standard health message + TRI

Group XIV: Condition 11 Experimental Treatment 3 Interventions

Standard health message + TRI + AP

Group XV: Condition 10 Experimental Treatment 3 Interventions

Standard health message + TRI + MI

Group XVI: Condition 1 Experimental Treatment 5 Interventions

Standard health message + VA + TRI + MI+ AP

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Kaiser Foundation Research Institute

Collaborator

Trials

28

Recruited

21,300+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study involved 59 women with recent gestational diabetes and aimed to evaluate a diabetes risk reduction intervention, which successfully improved dietary habits, including energy and fat intake.

Despite the positive changes in diet, the intervention did not lead to increased physical activity, and recruitment for the study was more difficult than anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. Smith, BJ., Cinnadaio, N., Cheung, NW., et al.[2022]

The STAR MAMA trial is testing a 20-week postpartum program based on the Diabetes Prevention Program (DPP) to help low-income minority women with prior gestational diabetes or high BMIs reduce their risk of developing diabetes, targeting 180 women in San Francisco and Sonoma Counties.

Preliminary results show high engagement among participants, with 86% responding to health coaching calls, indicating that community-based adaptations of the DPP can effectively support postpartum women in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking High Risk Postpartum Women with a Technology Enabled Health Coaching Program to Reduce Diabetes Risk and Improve Wellbeing: Program Description, Case Studies, and Recommendations for Community Health Coaching Programs. Athavale, P., Thomas, M., Delgadillo-Duenas, AT., et al.[2021]

An 18-month quality improvement project involving 15 clinical practices aimed to enhance postpartum Type 2 diabetes screening rates in women with a history of gestational diabetes, resulting in 67% of women having a documented postpartum visit and 33% undergoing T2DM screening.

The project successfully improved the delivery of patient education on important topics like GDM screening and T2DM risk reduction, but highlighted ongoing challenges in communication between prenatal and postpartum care providers that hindered optimal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ohio Gestational Diabetes Postpartum Care Learning Collaborative: Development of a Quality Improvement Initiative to Improve Systems of Care for Women. Shellhaas, C., Conrey, E., Crane, D., et al.[2023]

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