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Behavioral Intervention

Breastfeeding Support + Diabetes Prevention for Post-Pregnancy Weight Loss

N/A

Recruiting

Led By Lisette Jacobson, PhD, MPA, MA

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old or older

In second trimester or early third trimester

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after week 36 of pregnancy but prior to delivery, and after month 3 postpartum.

Summary

"This trial aims to see if a program called eMOMS, which combines breastfeeding support with a diabetes prevention program, can help women who were overweight or obese before pregnancy to lose weight after giving birth

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves lifestyle coaching rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort from changing habits or using new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after week 36 of pregnancy but prior to delivery, and after month 3 postpartum.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after week 36 of pregnancy but prior to delivery, and after month 3 postpartum.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after week 36 of pregnancy but prior to delivery, and after month 3 postpartum. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Lactation

Initiation of Lactation

Maternal body mass index (BMI)

+2 more

Secondary study objectives

Health Coach Interaction

Mobile Application Usage

Recruitment Rate

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DPP + Breastfeeding (Tx1)Active Control3 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 CarePlacebo Group1 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.

0 / 2Eligibility criteria met