Lifestyle Intervention for Gestational Diabetes Postpartum Care

(DEPART Trial)

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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Active control lifestyle intervention, Lifestyle intervention for Gestational Diabetes Postpartum Care?

Research indicates that lifestyle interventions are highly acceptable and have the potential to improve care for women with gestational diabetes, particularly in preventing type 2 diabetes. These interventions have been shown to improve dietary quality and are well-received by both women and healthcare professionals. ^{1 2 3 4 5}

Is the lifestyle intervention for gestational diabetes postpartum care safe?

The research articles do not provide specific safety data for the lifestyle intervention, but lifestyle interventions generally focus on healthy habits like diet and exercise, which are typically safe for most people. ^{1 3 5 6 7}

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

The lifestyle intervention treatment for gestational diabetes postpartum care is unique because it focuses on modifying daily habits and behaviors to reduce the risk of developing type 2 diabetes, rather than relying on medication. This approach is tailored to the needs of postpartum women and includes support for overcoming barriers like reduced self-care priority and societal influences, making it a more holistic and personalized option compared to standard drug treatments like metformin. ^{1 2 3 6 8}

What is the purpose of this trial?

The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.

Research Team

Julie Robitaille, RD PhD

Principal Investigator

Laval University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Designing a lifestyle intervention to reduce risk of type 2 diabetes in postpartum mothers following gestational diabetes: An online survey with mothers and health professionals. [2018]

2. 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]

3. England 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. [2021]

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

Systematic Review of Lifestyle Interventions for Gestational Diabetes Mellitus in Pregnancy and the Postpartum Period. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications. [2021]

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

Postpartum Use of Weight Loss and Metformin for the Prevention of Type 2 Diabetes Mellitus: a Review of the Evidence. [2021]