Lifestyle Intervention for Gestational Diabetes Postpartum Care

(DEPART Trial)

Not currently recruiting at 1 trial location

Overseen By Julie Perron, RD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Bariatric surgery, Type 1 or 2 diabetes, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a lifestyle program can help women who had gestational diabetes (diabetes during pregnancy) manage their weight after giving birth. Participants will join either an active group with personalized sessions on breastfeeding, healthy eating, and exercise, or a control group receiving standard lifestyle advice. Women who had gestational diabetes, experienced a single pregnancy, and are fluent in French are ideal candidates for this study. The aim is to determine if these lifestyle changes can improve postpartum health. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes can enhance postpartum well-being.

Do I need to stop my current medications for this 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.

What prior data suggests that this lifestyle intervention is safe for postpartum women with gestational diabetes?

Earlier studies have shown that lifestyle changes for women who had gestational diabetes (GDM) are safe. Research indicates that healthy eating, staying active, and breastfeeding can help women without causing harm. These changes can manage weight and lower the risk of developing type 2 diabetes after pregnancy.

The reviewed studies did not find any major negative effects from these lifestyle changes. Instead, they suggest that these changes are well-tolerated and can lead to better health. Current evidence supports that making these lifestyle changes is generally safe for new mothers recovering from GDM. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for postpartum care in gestational diabetes because it offers a more personalized and supportive approach compared to standard care. Unlike the typical written advice given to new moms, this intervention includes one-on-one sessions both in-person and over the phone, focusing on exclusive breastfeeding, healthy eating, and physical activity over an entire year. This hands-on support is designed to help women make lasting lifestyle changes, potentially leading to better health outcomes for both mothers and their babies.

What evidence suggests that this lifestyle intervention is effective for minimizing postpartum weight retention in women with recent gestational diabetes?

This trial will compare two approaches to lifestyle intervention for women who had gestational diabetes (GDM) during pregnancy. Participants in the intervention group will engage in a structured 1-year lifestyle program focusing on healthy eating, regular exercise, and breastfeeding. Studies have shown that such lifestyle changes can help prevent retaining extra weight after pregnancy and lower the risk of developing type 2 diabetes. Meanwhile, the active control group will receive standard lifestyle recommendations in written form. Overall, these programs have improved health for women with a history of GDM. ^{1 2 3 4 6}

Who Is on the Research Team?

Julie Robitaille, RD PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for women over 18 who had a single baby recently, were diagnosed with gestational diabetes (GDM), and have a pre-pregnancy BMI of at least 18.5. They must speak French fluently and not plan to get pregnant in the next year or have had bariatric surgery or any type of diabetes before.

Inclusion Criteria

Had a singleton pregnancy

With a reported pre-pregnancy BMI ≥18.5 kg/m2

I am pregnant and have been diagnosed with gestational diabetes.

Exclusion Criteria

I am a woman with a history of diabetes.

I am pregnant with more than one baby.

Women who plan another pregnancy in the following year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants engage in a 1-year lifestyle intervention program with 7 face-to-face sessions and 7 phone sessions focusing on exclusive breastfeeding, healthy diet, and regular physical activity

12 months

7 face-to-face visits, 7 phone sessions

Follow-up

Participants are monitored for metabolic and anthropometric measurements at 18 months postpartum

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active control lifestyle intervention
• Lifestyle intervention

Trial Overview The study tests if a program encouraging exclusive breastfeeding, healthy eating, and regular exercise can help women with recent GDM lose weight after giving birth. Participants will be compared to an active control group also following lifestyle changes.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

At 2-mo postpartum, women will start the 1-yr lifestyle intervention that will consist of 7 face-to-face individual sessions of 1-hr (at 2, 3, 4, 5, 6, 9, 12 mo postpartum and a follow-up at 18 mo). Metabolic and anthropometric measurements will be assessed at 2,6,12 and 18 mo postpartum. In addition, 7 individual sessions of 30 min between face-to-face sessions will be carried out on the phone. Benefits of exclusive breastfeeding, healthy eating and physical activity will be portrayed at each visit .

Group II: Active control lifestyle intervention Active Control 1 Intervention

Women in the control group will come to the testing unit at 2, 6, 12 and 18 mo postpartum for metabolic and anthropometric measurements and at 3, 4, 5, 9 mo for weight measurements only. They will receive standard lifestyle recommendations in the form of written information at each visit.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

The study highlights both enabling factors and barriers faced by staff implementing a postpartum lifestyle intervention for Latinas at risk for type 2 diabetes, emphasizing the importance of cultural connection and flexible sessions in promoting participant engagement.

Barriers such as financial insecurity, low health literacy, and participant resistance to behavior change were significant challenges, suggesting that future interventions need to address these contextual issues to improve adherence and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. Gubrium, A., Leckenby, D., Harvey, MW., et al.[2021]

Women with gestational diabetes who successfully managed their condition through lifestyle modifications were generally younger and had a lower pre-pregnancy body mass index compared to those who required medication, suggesting that these factors may influence glycemic control outcomes.

The study identified specific diagnostic parameters, such as glucose challenge test and fasting oral glucose tolerance test results, that can help predict which women are likely to need anti-diabetic medications instead of achieving control through lifestyle changes alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications. Krispin, E., Ashkenazi Katz, A., Shmuel, E., et al.[2021]

A group-based lifestyle modification program for women with previous gestational diabetes showed some improvement in dietary quality, particularly in dairy consumption, but overall diet quality remained low after 12 months.

While the intervention group reduced alcohol intake by 2% and improved dairy scores, the total Australian Recommended Food Score (ARFS) did not significantly change, indicating a need for more effective strategies to enhance dietary quality in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes. O'Reilly, S., Versace, V., Mohebbi, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3120183/

A Pregnancy and Postpartum Lifestyle Intervention in ... This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention.

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/s43856-024-00491-1

Effective interventions in preventing gestational diabetes ... Overall, lifestyle intervention reduced the incidence of GDM by 22% (RR 0.78; 95% CI 0.72, 0.85; I2 = 45%). The difference between lifestyle ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00102-0/fulltext

a 1-year, prospective, multicentre, randomised controlled trial Primary outcome was achieved by 46.3% (56) of intervention participants compared to 43.3% (52) in the control group [odds ratio (OR) 1.13, 95% ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0884217521002999

Systematic Review of Lifestyle Interventions for Gestational ... Lifestyle interventions provided during and after pregnancy to reduce the risk associated with GDM have the potential to improve outcomes.

6. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(24)00198-5/fulltext

the lifestyle InterVention in gestational diabetes (LIVING ... Utilising data from 1299 women in the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, two models were developed: one for pregnancy and another ...