DPP Feasibility Study of Breastfeeding - eMOMS 2.0

Not Applicable

Active, not recruiting

• Conditions: Pregnancy; Overweight or Obesity
• Interventions: Behavioral: Diabetes Prevention Program; Behavioral: Breastfeeding; Behavioral: Usual Care

• Registration Number: NCT06372860
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention-based program (DPP) in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum. The trial will have two study arms: DPP + breastfeeding (Tx1) and Usual Care (Tx2).

Aim 1: Quantify interest in use of the DPP-lactation mobile health (mHealth) application among target population. To accomplish this, we will: (1) measure research engagement including rates of screening, recruitment, and retention among users, especially rural and racially/ethnically diverse women; (2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence via tracking/measuring use of the mHealth app.

Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among target population. To accomplish this, we will measure pre-pregnancy weight, weight at study entry, weight immediately prior to and after delivery, and weight at specific postpartum time points. Lactation and infant feeding practices will be measured at similar postpartum time points.

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Pregnant
• In second trimester or early third trimester
• BMI >/= 25 and < 35
• At least 18 years old or older
• Able to read and understand English
• Able to learn and use a video platform

Exclusion Criteria

• Complications related to pregnancy that require emergency care
• Thyroid disease
• Multiple gestation
• Substance abuse within last 3 years
• Assisted reproductive technology (ART)-related pregnancy
• Current smoker
• Prior bariatric surgery
• In weight-loss program within 3 months of conception
• BMI >/= 35
• Unable to attend intervention/ follow-up visits
• Unwilling to self-monitor data collection
• Unable to complete intervention
• Presence of any condition that limits walking
• Presence of any condition that limits following diet recommendations
• Pregnancies complicated with fetuses diagnosed with lethal malformations/conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPP + Breastfeeding (Tx1)	Usual Care	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.
DPP + Breastfeeding (Tx1)	Diabetes Prevention Program	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.
Usual Care	Usual Care	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.
DPP + Breastfeeding (Tx1)	Breastfeeding	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.

Primary Outcome Measures

Name	Time	Method
Duration of Lactation	At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.	The study team will measure duration of maternal ability to breastfeed at specific timepoints.
Maternal body mass index (BMI)	At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.	Body mass index (BMI) is a measure of body fat based on height and weight. The study team will measure BMI and to allow for meaningful comparisons of weight change among study arms.
Maternal weight	At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.	The study team will measure maternal weight to calculate maternal BMI and to allow for meaningful comparisons of weight change among study arms.
Initiation of Lactation	At delivery.	The study team will assess whether (yes/no) lactation was initiated at birth.
Type of Infant Feeding	At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.	The study team will measure "exclusive" lactation (human milk only) versus "any" lactation (predominant human milk with formula or solid food supplementation) at specific timepoints.

Secondary Outcome Measures

Name	Time	Method
Retention Rate	This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.	To assess retention rate, the study team will track the percent (%) of participants who complete the intervention.
Mobile Application Usage	This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.	To assess intervention uptake, the study team will track the amount of time spent on each session on the mobile app.
Recruitment Rate	This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.	To assess recruitment rate, the study team will track the percent (%) of potential participants contacted versus the percent (%) of participants enrolled in the study.
Health Coach Interaction	This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.	To assess intervention uptake, the study team will track the amount of time spent with the health coach.
Research Engagement	After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.	Participants who complete each phase of the program will be invited to participate in focus groups to discuss program experiences.

Trial Locations

Locations (1)

Via Christi Maternal Fetal Medicine Clinic; 🇺🇸 Wichita, Kansas, United States