DPP Feasibility Study of Breastfeeding - eMOMS 2.0

April 15, 2024 updated by: Lisette Jacobson, University of Kansas Medical Center

Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lisette Jacobson, PhD, MPA, MA
  • Phone Number: 316-293-3484
  • Email: ljacobson@kumc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DPP + Breastfeeding (Tx1)
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: Usual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Behavioral: Diabetes Prevention Program

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.

Behavioral: Breastfeeding

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: At delivery.
The study team will assess whether (yes/no) lactation was initiated at birth.
At delivery.
Duration of Lactation
Time Frame: 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.
At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
Type of Infant Feeding
Time Frame: 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.
At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: 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.
This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Retention Rate
Time Frame: 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.
This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Research Engagement
Time Frame: 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.
After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.
Mobile Application Usage
Time Frame: 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.
This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Health Coach Interaction
Time Frame: 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.
This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of General Medical Sciences (NIGMS)
Ascension Health

Investigators

  • Principal Investigator: Lisette Jacobson, PhD, MPA, MA, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RKS2018350
  • 3P20GM144269-02S2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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