Recruiting

RSNDietary and Antenatal Breastmilk Expression Interventions for Breastfeeding in Women with Excessive Weight

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Lactation Support and ABME

+ Lactation Support and meal plan

+ Lactation Support

Other
Who is being recruted

Behavior+9

+ Body Weight

+ Breast Feeding

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorArkansas Children's Hospital Research Institute
Study ContactAline Andres, PhD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 7, 2025

Actual date on which the first participant was enrolled.

This study aims to explore how certain strategies can help women with excess weight achieve better breastfeeding outcomes. It focuses on women who are overweight or obese, as they often face challenges in starting and continuing to breastfeed. The study is important because effective breastfeeding offers many health benefits for both mothers and infants, such as reducing the risk of childhood obesity and improving maternal and child health. By understanding how dietary changes and special breastfeeding techniques can help, the study seeks to improve breastfeeding success rates and provide clear guidelines for this group of women. Participants in this study will receive a dietary intervention designed to align with the Dietary Guidelines for Americans and education about antenatal breastmilk expression (ABME), which is a technique to express milk before the baby is born. The study will measure whether these interventions enhance breastfeeding initiation, duration, and exclusivity, as well as improve the composition of breast milk. The primary outcomes include better breastfeeding practices and milk quality, while secondary outcomes focus on longer breastfeeding periods and increased confidence in breastfeeding. This research could lead to valuable insights and recommendations for dietary support for lactating women with excessive weight.

Official TitleReady, Set, Nourish Study
Principal SponsorArkansas Children's Hospital Research Institute
Study ContactAline Andres, PhD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightBreast FeedingFeeding BehaviorNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightBreast Milk Expression

Criteria

Inclusion Criteria * 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 * Reside in Central Arkansas region Exclusion Criteria * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group will receive instructions on Antenatal Breast Milk Expression (ABME) and have collection of colostrum before delivery.

Group II

Experimental
Participants will receive lactation support and a 5.5-month postpartum dietary program aligned with the Dietary Guidelines for Americans.

Group III

Experimental
This group helps researchers compare the effects of the intervention by serving as a baseline for what would happen without ABME technique or a dietary intervention.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Arkansas Children's Nutrition Center

Little Rock, United StatesOpen Arkansas Children's Nutrition Center in Google Maps
Recruiting soon

Arkansas Children's Nutrition Center

Little Rock, United States
Recruiting
2 Study Centers
RSN | Dietary and Antenatal Breastmilk Expression Interventions for Breastfeeding in Women with Excessive Weight | PatLynk