Lifestyle Interventions for Gestational Diabetes

Not yet recruiting at 2 trial locations

Overseen By Brooke Latzke-Davis, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: California Polytechnic State University-San Luis Obispo

Disqualifiers: Pre-existing diabetes

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of home-based support can help individuals with gestational diabetes (a type of diabetes that develops during pregnancy) manage their health after giving birth. One group will receive special meals and lifestyle advice, while the other group will receive only lifestyle advice. The goal is to determine if these approaches, including the GDM Enhanced program, can reduce the risk of diabetes and improve health factors like weight and blood pressure within a year after childbirth. This trial may suit those who are pregnant or recently had a baby, have experienced gestational diabetes in their most recent pregnancy, and are currently participating in home visiting programs. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance postpartum health care options.

Do I need to stop my current medications for the trial?

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?

Studies have shown that better education about gestational diabetes can help manage blood sugar levels and improve quality of life. Research indicates that this approach is generally safe and well-tolerated. Although gestational diabetes can lead to risks like early delivery or needing a cesarean section, these are not directly linked to the education program.

Medically tailored meals, another part of the treatment, have proven practical and acceptable for pregnant patients with diabetes. These meals are specially prepared to meet the nutritional needs of someone with a specific medical condition. Research suggests they can reduce healthcare visits and improve health outcomes for those with diet-related conditions.

Overall, both enhanced gestational diabetes education and medically tailored meals have demonstrated positive safety records in previous studies. Participants generally handle these interventions well, with no significant negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GDM Enhanced treatment for gestational diabetes because it offers a comprehensive lifestyle approach that goes beyond standard care options like dietary changes and insulin therapy. This treatment uniquely combines enhanced home visitation with medically tailored meals, aiming to provide personalized support and nutrition guidance. By focusing on these tailored interventions, it has the potential to improve blood sugar control and overall health outcomes for pregnant women with gestational diabetes.

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

Research has shown that lifestyle changes can help manage gestational diabetes (GDM). Studies have found that combining healthy eating with regular exercise lowers the risk of GDM. This approach also helps control blood sugar levels, which is crucial for managing diabetes. For those who have had GDM, lifestyle changes after pregnancy can help prevent type 2 diabetes.

In this trial, one group will receive the GDM Enhanced intervention along with medically tailored meals (MTMs). These meals are specially designed to meet health needs and simplify healthy eating, making diabetes management easier. Participants often find better access to nutritious food and feel less stressed about meal planning, which helps them manage their diabetes more effectively. Another group will receive the GDM Enhanced intervention without the meals. ^{6 7 8 9 10}

Who Is on the Research Team?

Suzanne Phelan, PhD

Principal Investigator

California Polytechnic State University-San Luis Obispo

Are You a Good Fit for This Trial?

This trial is for nearly a thousand pregnant or recently pregnant adults with recent gestational diabetes mellitus (GDM), from various regions and backgrounds. The study aims to see if certain lifestyle interventions can prevent diabetes postpartum.

Inclusion Criteria

Pregnant or less than 3 months (13 weeks) postpartum

Currently in home visiting

Not currently being given medically tailored meals

Exclusion Criteria

Pre-existing diabetes (based on self-report)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GDM Enhanced lifestyle intervention plus medically tailored meals or GDM Enhanced Only within home visiting

12 months

Regular home visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of glucose tolerance, weight, blood pressure, and other health factors

12 months

Assessments at 3, 6, and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• GDM Enhanced
• Meals

Trial Overview The study compares two treatments: one group receives enhanced lifestyle support for GDM plus medically tailored meals, while the other gets just the enhanced lifestyle support. It will track effects on diabetes prevention, weight, and blood pressure up to 12 months after giving birth.

How Is the Trial Designed?

Group I: Usual HV + GDM Enhanced + Meals Experimental Treatment 2 Interventions

This group will receive usual home visitation plus GDM Enhanced plus medically tailored meals.

Group II: Usual Home Visiting plus GDM Enhanced Active Control 1 Intervention

This group receives usual home visitation plus GDM Enhanced intervention.

Who Is Running the Clinical Trial?

California Polytechnic State University-San Luis Obispo

Lead Sponsor

Trials

33

Recruited

3,400+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Lifespan/ The Miriam Hospital

Collaborator

Trials

1

Recruited

260+

Bradley Hospital

Collaborator

Trials

22

Recruited

1,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11032369/

Effective interventions in preventing gestational diabetes ... Combined diet and physical activity interventions conducted in low-middle-income countries demonstrated a greater reduction in GDM than in upper ...

2. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01606-x

Lifestyle intervention to prevent type 2 diabetes after a ... LSI offered to women with GDM following pregnancy is effective in preventing type 2 diabetes, despite the small postpartum weight change.

3. nature.com nature.com/articles/s41387-023-00251-5

Effectiveness of pre-pregnancy lifestyle in preventing ... A recent systematic review during pregnancy showed that structured dietary intervention can reduce the risk of GDM by about 39% in 3029 women [ ...

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1347754/full

Comprehensive management of gestational diabetes mellitus Studies on GDM treatment showed improved glucose control in the exercise group post-intervention (Mean Difference (MD)=-0.10; 95% CI: -0.16 to - ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2025/07250/effectiveness_of_a_risk_perception_based_nursing.74.aspx

Effectiveness of a risk perception-based nursing model for... GDM not only heightens the risk of maternal hypertension, preterm birth, and infections during pregnancy but also has long-term adverse effects ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12514800/

Enhancing gestational diabetes mellitus education Outcomes were assessed pre- and post-intervention, including blood glucose levels, glycated hemoglobin (HbA1c), anxiety levels, quality of life, ...

7. nature.com nature.com/articles/s43856-024-00491-1

Effective interventions in preventing gestational diabetes ... GDM poses several maternal health complications, including an increased risk of pre-eclampsia, caesarean delivery, and labor induction.

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214956

Treatment of Gestational Diabetes Mellitus Diagnosed ... An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the ...

9. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07932-2

a randomized controlled trial of King's theory and FMEA ... Outcomes were assessed pre- and post-intervention, including blood glucose levels, glycated hemoglobin (HbA1c), anxiety levels, quality of life, ...

10. bmj.com bmj.com/content/377/bmj-2021-067946

Gestational diabetes mellitus and adverse pregnancy ... The findings of the study showed that maternal hyperglycaemia independently increased the risk of preterm delivery, caesarean delivery, infants ...