Breastfeeding Support + Diabetes Prevention for Post-Pregnancy Weight Loss

Overseen By Lisette Jacobson, PhD, MPA, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Thyroid disease, Substance abuse, Smoker, others

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 idea that Breastfeeding Support + Diabetes Prevention for Post-Pregnancy Weight Loss is an effective treatment?

The available research shows that interventions supporting breastfeeding can improve outcomes for women with gestational diabetes or obesity. Specifically, women who received support were more likely to continue breastfeeding exclusively in the early weeks after birth and up to six months. This suggests that the treatment can be effective in helping women manage their weight and health after pregnancy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment eMOMS 2.0 for post-pregnancy weight loss?

Research shows that breastfeeding interventions can help women with gestational diabetes or obesity to breastfeed more successfully, which may support weight loss after pregnancy. Women in these interventions were more likely to exclusively breastfeed in the early weeks and continue breastfeeding for at least 6 months. ^{1 2 3 4 5}

What safety data exists for the Breastfeeding Support + Diabetes Prevention treatment?

The available research primarily focuses on the benefits of breastfeeding interventions for women with gestational diabetes mellitus (GDM) and their infants, highlighting improved breastfeeding outcomes and potential reductions in metabolic risks. However, specific safety data for the Breastfeeding Support + Diabetes Prevention treatment, including under names like eMOMS, is not directly addressed in the provided studies. Further research, particularly randomized controlled trials, is needed to confirm the efficacy and safety of these interventions. ^{5 6 7 8 9}

Is the Breastfeeding Support + Diabetes Prevention treatment safe for humans?

The research suggests that breastfeeding interventions are generally safe and beneficial for both mothers and infants, especially for those with gestational diabetes or obesity. However, more studies are needed to fully understand any potential risks. ^{5 6 7 8 9}

Is the treatment eMOMS a promising treatment for post-pregnancy weight loss and diabetes prevention?

Yes, eMOMS is a promising treatment because it supports breastfeeding, which can help prevent diabetes in both mothers and children. Breastfeeding has been shown to lower the risk of diabetes and improve weight loss after pregnancy, especially for women with gestational diabetes or obesity. ^{1 2 5 7 10}

How is the eMOMS treatment different from other treatments for post-pregnancy weight loss and diabetes prevention?

The eMOMS treatment is unique because it combines breastfeeding support with electronic monitoring to help new mothers manage their schedules, which may aid in weight loss and diabetes prevention. This approach leverages the benefits of breastfeeding, which can lower the risk of diabetes, while using technology to support and enhance the mother's ability to maintain healthy habits. ^{1 2 5 7 10}

What is the purpose of this trial?

The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.

Research Team

Lisette Jacobson, PhD, MPA, MA

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for pregnant women in their second or early third trimester, who are at least 18 years old, can read and understand English, and have a pre-pregnancy BMI between 25 and 35. It's not suitable for those unable to use a video platform.

Inclusion Criteria

I can learn and use video call software.

I am currently pregnant.

I am in my second or early third trimester of pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antepartum Education

Participants receive four 1-hour DPP-based educational sessions and six 20-minute educational videos on lactation

Up to week 36 of pregnancy

4 in-person sessions, 6 video sessions

Postpartum Education and Support

Participants receive in-hospital lactation support and two 1-hour DPP-based educational sessions, with ongoing 1-on-1 health coaching

3 months postpartum

2 in-person sessions, ongoing virtual coaching

Follow-up

Participants are monitored for weight, lactation duration, and infant feeding practices

3 months postpartum

Regular check-ins at specified postpartum time points

Treatment Details

Interventions

• eMOMS

Trial Overview The study examines the effects of eMOMS—an mHealth app-delivered program combining breastfeeding support with diabetes prevention strategies—on postpartum weight retention and lactation duration among overweight or obese women.

Participant Groups

Group I: DPP + Breastfeeding (Tx1) Active Control 3 Interventions

Patients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum.

Group II: Usual Care Placebo Group 1 Intervention

Usual care is described as obstetrical care that pregnant women with normal BMI receive and that is provided by their provider. There will not be any antepartum education or 1-on-1 health coaching. Postpartum education will only include usual care in-hospital lactation support. There will not be any other education nor 1-on-1 support.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+

Findings from Research

In a study of 66 women with Type 1 Diabetes Mellitus, breastfeeding did not significantly change postpartum insulin requirements, HbA1c levels, or pregnancy weight retention during the first year after delivery.

While insulin requirements increased overall, women who breastfed had lower daily insulin needs compared to those who did not, and the increase in HbA1c levels was more pronounced in non-breastfeeding women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding and insulin requirements in women with Type 1 diabetes mellitus in the first year postpartum. Skajaa, GØ., Kampmann, U., Ovesen, PG., et al.[2023]

A study of 102 women with type 1 diabetes found that 86% initiated breast-feeding shortly after delivery, and 54% were exclusively breast-feeding at 4 months, which is similar to the general population.

Key factors that predicted successful exclusive breast-feeding at 4 months included previous breast-feeding experience and a higher educational level, while maternal diabetes status did not significantly impact breast-feeding outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term breast-feeding in women with type 1 diabetes. Stage, E., Nørgård, H., Damm, P., et al.[2022]

The introduction of a hospital policy aimed at supporting breastfeeding in women with gestational diabetes mellitus (GDM) or type 2 diabetes did not significantly change the rates of infants receiving breast milk at discharge, with 58% in both pre- and post-policy groups.

There was also no significant increase in the number of infants exclusively receiving breast milk during their hospital stay after the policy was implemented, indicating a need for further evaluation and improvement of breastfeeding support practices for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Hospital Feeding Practices of Infants Born to Mothers With Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus: Evaluating Policy Implementation Effectiveness. Carmody, E., Richards, T., Hayward, K., et al.[2020]

In a study of 82 women with gestational diabetes mellitus (GDM), higher levels of fasting glucose, hemoglobin A1c, body mass index (BMI), and skinfold thickness were linked to earlier cessation of breastfeeding.

Women with elevated fasting glucose were more likely to wean earlier and introduce formula sooner, suggesting that these metabolic markers could help identify mothers who may need additional support to meet their breastfeeding goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Metabolic Dysfunction with Breastfeeding Outcomes in Gestational Diabetes. Glover, AV., Berry, DC., Schwartz, TA., et al.[2022]

Breastfeeding interventions significantly improved outcomes for women with overweight/obesity or gestational diabetes, increasing the likelihood of any breastfeeding at 6 months (OR 1.43) and exclusive breastfeeding at 1-2 weeks (OR 1.9) and 4-6 weeks (OR 2.23).

The review included 19 trials with 2,740 participants, indicating that targeted interventions can effectively support at-risk mothers in achieving better breastfeeding practices, although further research is needed to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to support women with overweight or obesity or gestational diabetes mellitus to initiate and continue breastfeeding: Systematic review and meta-analysis. Reichental, ZL., O'Brien, VM., O'Reilly, SL.[2022]

A cluster randomized trial involving 100 women with gestational diabetes mellitus (GDM) showed that a targeted breastfeeding education and support program significantly increased breastfeeding duration and reduced the likelihood of introducing formula early.

Women in the intervention group were 60% less likely to stop breastfeeding and 50% less likely to introduce formula compared to the control group, indicating the program's effectiveness in promoting longer breastfeeding among this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Stuebe, AM., Bonuck, K., Adatorwovor, R., et al.[2018]

Exclusive breastfeeding for the first 3 months significantly lowers the risk of childhood overweight in children of mothers with gestational diabetes mellitus (GDM), with an odds ratio of 0.479, indicating nearly a 52% reduction in risk compared to artificial feeding.

Breastfeeding for longer durations (up to 6 months) continues to reduce the risk of childhood overweight, but extending breastfeeding beyond 6 months does not provide additional benefits in reducing this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of breastfeeding on childhood overweight in the offspring of mothers with gestational diabetes mellitus]. Zhao, YL., Ma, RM., Huang, YK., et al.[2013]

This scoping review aims to evaluate the maternal and infant outcomes associated with antenatal breastmilk expression (BME), particularly for mothers with diabetes, highlighting the need for more research on its benefits and potential harms.

The review will systematically analyze existing literature, including both published and unpublished studies, to provide insights into how antenatal BME affects breastfeeding initiation, duration, and the overall experiences of mothers, especially in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and newborn outcomes of antenatal breastmilk expression: a scoping review protocol. Foudil-Bey, I., Murphy, MS., Keely, EJ., et al.[2023]

Breastfeeding offers significant health benefits for both mothers who are obese or have experienced gestational diabetes mellitus (GDM), helping to reduce the risk of developing metabolic syndrome and type 2 diabetes in these women.

Evidence suggests that breastfeeding can also lower the risk of metabolic disorders in children born to mothers with GDM, highlighting its importance in promoting long-term health for both mothers and their offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting breastfeeding among obese women and women with gestational diabetes mellitus. Trout, KK., Averbuch, T., Barowski, M.[2021]

Breastfeeding may provide protective benefits against diabetes for both mothers and their children, with evidence suggesting that breastfeeding for at least 2 months can lower the risk of diabetes in children.

Women with type 2 or gestational diabetes face challenges in breastfeeding due to higher rates of pregnancy complications, but they should be strongly encouraged to breastfeed due to the additional benefits related to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the literature associating breastfeeding with type 2 diabetes and gestational diabetes. Taylor, JS., Kacmar, JE., Nothnagle, M., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Breastfeeding and insulin requirements in women with Type 1 diabetes mellitus in the first year postpartum. [2023]

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

Long-term breast-feeding in women with type 1 diabetes. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

In-Hospital Feeding Practices of Infants Born to Mothers With Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus: Evaluating Policy Implementation Effectiveness. [2020]

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

The Association of Metabolic Dysfunction with Breastfeeding Outcomes in Gestational Diabetes. [2022]

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

Interventions to support women with overweight or obesity or gestational diabetes mellitus to initiate and continue breastfeeding: Systematic review and meta-analysis. [2022]

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

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Effect of breastfeeding on childhood overweight in the offspring of mothers with gestational diabetes mellitus]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Maternal and newborn outcomes of antenatal breastmilk expression: a scoping review protocol. [2023]

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

Promoting breastfeeding among obese women and women with gestational diabetes mellitus. [2021]

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

A systematic review of the literature associating breastfeeding with type 2 diabetes and gestational diabetes. [2022]