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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combined program of breastfeeding support and diabetes prevention can help women with pre-pregnancy overweight or obesity lose weight after childbirth. Participants will either receive standard postpartum care or access a mobile app with personalized coaching and educational resources, known as eMOMS (Electronic Monitoring of Mom's Schedule). This trial suits pregnant women in their second or early third trimester with a BMI between 25 and 35, who can use video technology and speak English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum health strategies.

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 prior data suggests that this intervention is safe for postpartum women?

Research shows that combining breastfeeding support with diabetes prevention is safe and beneficial. Breastfeeding can help women lose weight after having a baby and reduce the risk of diabetes, especially for those who had gestational diabetes or are overweight.

Studies indicate that programs to prevent diabetes after childbirth can lower the risk of developing type 2 diabetes by promoting healthy habits. In similar trials, no serious side effects were reported, suggesting that this combined approach is well-tolerated.

The program, called eMOMS, uses a mobile app to provide education and support. It helps women lose weight and breastfeed longer after giving birth. Overall, research supports that this type of program is generally safe for women after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines breastfeeding support with the Diabetes Prevention Program (DPP) to help new mothers manage post-pregnancy weight and prevent diabetes. Unlike standard postpartum care, which typically doesn't include targeted education or one-on-one coaching, this approach offers a personalized experience with access to a mobile health app and individual coaching sessions. This trial is exploring whether integrating intensive lactation support and DPP education can lead to better health outcomes by promoting healthier lifestyles from pregnancy through postpartum.

What evidence suggests that this trial's treatments could be effective for postpartum weight retention and lactation duration?

Research has shown that the Diabetes Prevention Program (DPP), which participants in this trial may receive, can lower the risk of developing type 2 diabetes by 58% through guidance on healthy lifestyle changes. One study found that people in these programs lost an average of 4.6 pounds over four months. Additionally, breastfeeding can aid weight loss after pregnancy and reduce the risk of diabetes, especially for women who had gestational diabetes or are overweight. This trial will compare the combination of DPP and breastfeeding support with usual care. Combining these methods may assist with weight loss after childbirth and support longer breastfeeding. Early results suggest that this type of program is practical and could be effective. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisette Jacobson, PhD, MPA, MA

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/02/NCT04021602/Prot_SAP_000.pdf

DPP Feasibility Study of Breastfeeding 1 Diabetes ...

The Diabetes Prevention Program (DPP) is associated with a reduced risk of developing T2DM by 58% through counseling on effective. Page 3. DPP Feasibility Study ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3717665/

Translation of the diabetes prevention program lifestyle ...

The intervention resulted in an average weight loss of 4.6 lb at a 4-month follow-up (p = 0.004). A dose–response association between intervention attendance ...

3.

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.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022316624003456

Effects of Breastfeeding Promotion Intervention and Dietary ...

This study aimed to examine the individual and interaction effects of a breastfeeding promotion intervention (BPI) and dietary intervention for weight loss ...

5.

withpower.com

withpower.com/trial/breastfeeding-support-diabetes-prevention-for-post-pregnancy-weight-loss-ea503

Breastfeeding Support + Diabetes Prevention for Post- ...

Breastfeeding has been shown to lower the risk of diabetes and improve weight loss after pregnancy, especially for women with gestational diabetes or obesity.

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06372860/dpp-feasibility-study-of-breastfeeding-emoms-20

DPP Feasibility Study of Breastfeeding - eMOMS 2.0

This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7183152/

Electronic Monitoring Of Mom's Schedule (eMOMS™)

It is anticipated that women in eMOMS1 will have greater weight loss and increased length of breastfeeding at three and six months postpartum compared to women ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168822725002839

Co-Designing a postpartum diabetes prevention program ...

Evidence indicates that postpartum diabetes prevention programs can reduce the incidence of T2DM in postpartum women after GDM through promoting physical ...

9.

wichita.edu

wichita.edu/about/conferences/documents/GPD-23-Jacobson-slides.pdf

Gestational Diabetes, Elevated BMI, & eMOMSTM

Reducing postpartum weight retention and improving breastfeeding outcomes in overweight women: a pilot randomised controlled trial. Nutrients.