DPP Feasibility Study of Breastfeeding - eMOMS 2.0

University of Kansas

Status: Completed

Conditions: Overweight or Obesity; Pregnancy

Treatments: Behavioral: Breastfeeding; Behavioral: Diabetes Prevention Program; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06372860

RKS2018350

3P20GM144269-02S2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups, including a placebo group

DPP + Breastfeeding (Tx1)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care

Behavioral: Diabetes Prevention Program

Behavioral: Breastfeeding

Usual Care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care