RSNDietary and Antenatal Breastmilk Expression Interventions for Breastfeeding in Women with Excessive Weight
Lactation Support and ABME
+ Lactation Support and meal plan
+ Lactation Support
Behavior+9
+ Body Weight
+ Breast Feeding
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy 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
Arkansas Children's Nutrition Center
Little Rock, United StatesOpen Arkansas Children's Nutrition Center in Google MapsArkansas Children's Nutrition Center
Little Rock, United States