Clinical trial NCT06372860: DPP Feasibility Study of Breastfeeding - eMOMS 2.0
Official title: Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Pregnancy
Keywords: diabetes prevention
breastfeeding
lactation support
prediabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Ascension Health
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-04-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal weight
timeFrame: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
measure: Maternal body mass index (BMI)
timeFrame: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
measure: Initiation of Lactation
timeFrame: At delivery.
measure: Duration of Lactation
timeFrame: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
measure: Type of Infant Feeding
timeFrame: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
Secondary outcomes:
measure: Recruitment Rate
timeFrame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
measure: Retention Rate
timeFrame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
measure: Research Engagement
timeFrame: After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.
measure: Mobile Application Usage
timeFrame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
measure: Health Coach Interaction
timeFrame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Via Christi Maternal Fetal Medicine Clinic
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Lisette Jacobson, PhD, MPA, MA
role: PRINCIPAL_INVESTIGATOR
References: