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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.
Awards & highlights

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of Lactation
Initiation of Lactation
Maternal body mass index (BMI)
+2 more
Secondary outcome measures
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.

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,405 Total Patients Enrolled
22 Trials studying Obesity
103,752 Patients Enrolled for Obesity
National Institute of General Medical Sciences (NIGMS)NIH
282 Previous Clinical Trials
248,189 Total Patients Enrolled
15 Trials studying Obesity
1,700 Patients Enrolled for Obesity
Ascension HealthIndustry Sponsor
26 Previous Clinical Trials
2,832 Total Patients Enrolled
1 Trials studying Obesity
30 Patients Enrolled for Obesity
~14 spots leftby Dec 2024
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