DPP Feasibility Study of Breastfeeding - eMOMS 2.0

NCT06372860 | Completed

• 2 other identifiers: RKS20183503P20GM144269-02S2
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Overweight or Obesity

Keywords

diabetes prevention; breastfeeding; lactation support; prediabetes

Outcome Measures

Primary Outcomes (5)

• Maternal weight

  The study team will measure maternal weight to calculate maternal BMI and to allow for meaningful comparisons of weight change among study arms.

  At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.

• Maternal body mass index (BMI)

  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.

  At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.

• Initiation of Lactation

  The study team will assess whether (yes/no) lactation was initiated at birth.

  At delivery.

• Duration of Lactation

  The study team will measure duration of maternal ability to breastfeed at specific timepoints.

  At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.

• Type of Infant Feeding

  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.

  At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.

Secondary Outcomes (5)

• Recruitment Rate

  This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.

• Retention Rate

  This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.

• Research Engagement

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

• Mobile Application Usage

  This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.

• Health Coach Interaction

  This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.

Study Arms (2)

DPP + Breastfeeding (Tx1)

ACTIVE COMPARATOR

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.

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

Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Interventions

Diabetes Prevention Program BEHAVIORAL

The intervention will be administered by professionally trained, certified health coaches. Phase I consists of four 1-hour DPP-based sessions to be completed during pregnancy. Each session will be pre-recorded and archived on a secure, private mHealth application. Participants will be asked to complete each session on their own time. A health coach will follow up weekly via phone to check on progress and will work with the participant 1-on-1, if needed. Phase I will be completed by week 36 of pregnancy. Prior to delivery, participants are invited to a virtual focus group about their experiences. Phase II consists of two 1-hour DPP-based sessions to be completed after delivery. Each session will be pre-recorded and archived on the same mHealth application. Participants will begin Phase II within 1 week of delivery with the same health coach. Phase II will be completed by week 12 postpartum. Upon completion, participants are invited to a virtual focus group about their experiences.

DPP + Breastfeeding (Tx1)

Breastfeeding BEHAVIORAL

Phase I also consists of six (6) breastfeeding videos that are pre-recorded into 15-20 minute sessions and will be available on the mHealth application. Participants will have access to the first 2 sessions by week 28 of pregnancy and need to complete the remaining 4 sessions by week 36 of pregnancy. Each session is taught by an International Board Certified Lactation Consultant (IBCLC). Participants will receive 1-on-1 lactation support by the same DPP health coach. The health coach is a professionally trained Certified Breastfeeding Specialist (CBS). She will assist participants with any questions related to lactation. If the health coach is unable to help with a specific issue, she will contact the IBCLC-of-record, who will provide assistance to the health coach only. If the health coach or IBCLC deems additional care necessary, the participant will be referred to their primary care physician. The IBCLC will not have direct contact with the study participants.

DPP + Breastfeeding (Tx1)

Usual Care BEHAVIORAL

Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.

DPP + Breastfeeding (Tx1); Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant must be a pregnant female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascension Health: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

Via Christi Maternal Fetal Medicine Clinic

Wichita, Kansas, 67218, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Breast Feeding; Prediabetic State

Interventions

Lactation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Lisette Jacobson, PhD, MPA, MA

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Population Health

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: April 30, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)