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Ready, Set, Nourish Study: Breastfeeding Support for Women with Excessive Weight

This study, called "Ready, Set, Nourish," is looking at ways to help women with excessive weight have better breastfeeding experiences. It's testing three different approaches: standard lactation support, lactation support combined with education on hand expression of colostrum (early breast milk) and a technique called ABME, and lactation support with a 5.5-month dietary program after birth. The study wants to see how these interventions affect your breast milk composition, when you start breastfeeding, and how long you breastfeed. You can join if you are 18 or older, less than 37 weeks pregnant with one baby, have a pre-pregnancy Body Mass Index (BMI) of 25 or higher, and are interested in breastfeeding. The study aims to enroll 240 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific support strategies. It plans to enroll 240 women.
What's involved
You would need to be willing to express colostrum if in a specific group, and express milk for samples during a 24-hour period. The dietary program lasts 5.5 months postpartum.
Compensation
Not stated in the trial record.
Follow-up
Your human milk composition and breastfeeding duration will be measured from birth to 6 months postpartum.

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NCT06929091

Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)

Recruiting
NAAges 18+InterventionalTreatment
Arkansas Children's Hospital Research Institute
~240 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Lactation Support and ABMELactation Support and meal planLactation Support

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Human Milk composition
Measured over From birth to 6 months postpartum
+2 more outcomes measured

Conditions

Breastfeeding
Dietary Intervention
Milk Expression, Breast

Explore related trials

ObesityPregnancy

Where it's being run

2 sites across 1 states
Arkansas2

Who to contact

Aline Andres, PhD.
[email protected]
501-364-3301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 or older
Less than 37 weeks of pregnant with singleton fetus
Pre-pregnancy excessive weight (Body Mass Index ≥ 25 kg/m2)
Interested in breastfeeding
Willing to express colostrum from around 37 weeks of pregnancy if randomized to the prenatal intervention group
Willing to express human milk for sample collection during a 24-hour period
Willing to adhere to a meal plan for 5.5 months post-partum if randomized to the postnatal intervention group
Able to engage in study procedures for the first 24 months postpartum

Exclusion

Pre-existing conditions (e.g. diabetes, hypertension, heart disease, thyroid disorders);
Use of recreational drugs, tobacco, or 2 or more servings of alcohol per month
Food allergies, intolerances, or preferences interfering with the meal plan
Medical history including any contraindication to breastfeeding (medications or supplements incompatible with breastfeeding, substance use)Multiparous pregnancy
History of breast surgery or radiation
Congenital defects
Preeclampsia

What this trial measures

  • Human Milk compositionFrom birth to 6 months postpartum

    Human Milk composition will be analyzed from milk samples collected at the postpartum visits (2 weeks, 1, 2, 3, 4, 5, and 6 months). Standardized collection and laboratory procedures described in the study protocol will be followed. Samples will be stored and analyzed at the Arkansas Children's Nutrition Center to evaluate milk composition over time across study groups.

  • Breastfeeding InitiationBirth to 2 weeks postpartum

    Breastfeeding initiation (defined as any breastfeeding within the first 24 hours after delivery) will be assessed using standardized Lactation Medical History questionnaire. Data will be obtained at first postpartum study visit, occurring at approximately 2 weeks postpartum. This assessment will provide quantitative data on breastfeeding practice across all study groups.

  • Breastfeeding DurationFrom birth to 6 months

    Breastfeeding duration (measured in cumulative days of any breastfeeding and exclusive breastfeeding) will be assessed using a standardized Lactation Medical History questionnaire. Data will be obtained at all postpartum study visits occurring approximately at 0.5, 1, 2, 3, 4, 5, and 6 months postpartum. These assessments will provide quantitative data on breastfeeding practices across all study groups.