Online Intervention for Gestational Diabetes Postpartum Care

(SUNRISE Trial)

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

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Action planning (AP), Motivational Interviewing-based (MI), Standard Health Information, Tailored Risk Information (TRI), Values Affirmation (VA) for gestational diabetes postpartum care?

Research shows that lifestyle interventions, which include motivational and planning strategies, are effective in improving postpartum care for women with gestational diabetes. These interventions are well-received and can help reduce the risk of developing type 2 diabetes by promoting healthy living and increasing physical activity. ^{1 2 3 4 5}

Is the online intervention for gestational diabetes postpartum care safe for humans?

The research articles reviewed do not provide specific safety data for the online intervention or related strategies like Action Planning, Motivational Interviewing, or Values Affirmation. However, these strategies are generally considered safe as they focus on lifestyle changes and education. ^{1 2 6 7 8}

How does the online intervention for gestational diabetes postpartum care differ from other treatments?

This online intervention is unique because it uses a digital platform to support lifestyle changes and diabetes management for women who had gestational diabetes, focusing on self-management and behavior change through technology, unlike traditional in-person or written education methods. ^{4 5 9 10 11}

Research Team

Susan D Brown, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

I am 18 years old or older.

You are currently pregnant and have gestational diabetes.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Self-efficacy and planning strategies can improve physical activity levels in women with a recent history of gestational diabetes mellitus. [2019]

2. United States 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Translating Healthy Living Messages to Postpartum Women and Their Partners After Gestational Diabetes (GDM): Body Habitus, A1C, Lifestyle Habits, and Program Engagement Results From the Families Defeating Diabetes (FDD) Randomized Trial. [2022]

5. England 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. [2021]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Complex intervention research for families with prior gestational diabetes mellitus]. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Designing a data set for postpartum recall registry of women with gestational diabetes in recent pregnancy and its implementation in Iranian urban health centers. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Experiences of using a digital type 2 diabetes prevention application designed to support women with previous gestational diabetes. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Identifying postpartum intervention approaches to prevent type 2 diabetes in women with a history of gestational diabetes. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Use of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education. [2019]