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Completed

NCT Number: NCT06372860

DPP Feasibility Study of Breastfeeding - eMOMS 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.

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Key information

Conditions

Overweight or Obesity Behavior Body Weight Breast Feeding Diabetes Mellitus Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Pregnancy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Via Christi Maternal Fetal Medicine Clinic

Wichita, Kansas, 67218, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Initiation of Lactation

    Time frame: At delivery.

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

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Ascension Health
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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