Actively Recruiting
Effect of Prenatal Hand Expression and Postnatal Dietary Program on Breastfeeding Outcomes in Women With Excessive Weight
Led by Arkansas Children's Hospital Research Institute · Updated on 2025-12-10
240
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ways to improve breastfeeding outcomes for women with excessive weight. This study focuses on how hand expression of breast milk or colostrum during pregnancy and a dietary program postpartum can support breastfeeding success and affect breast milk composition and infant growth. The study addresses challenges faced by women with overweight or obesity, including delayed milk production and lower breastfeeding rates, aiming to find effective support strategies. Participants are randomly assigned to one of three groups: standard lactation support, lactation support plus antenatal breast milk expression (ABME) education starting around 37 weeks of pregnancy, or lactation support plus a 5.5-month postpartum dietary program following the Dietary Guidelines for Americans. The ABME group receives training on hand expression of colostrum during late pregnancy, while the dietary group receives prepared meals and guidance to follow a healthy eating plan postpartum. During the study, researchers will collect breast milk samples from birth to six months postpartum and track breastfeeding initiation, duration, and exclusivity. Participants will complete assessments on breastfeeding self-efficacy and experience monitoring for delayed milk production. The study will also analyze how maternal diet affects milk composition and infant development. The total participation period includes pregnancy and up to 24 months postpartum to gather comprehensive data on breastfeeding and infant outcomes.
CONDITIONS
Brief Title
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Less than 37 weeks pregnant with a single fetus
- Pre-pregnancy body mass index of 25 kg/m2 or higher
- Interested in breastfeeding
- Willing to express colostrum starting around 37 weeks if assigned to prenatal intervention
- Willing to express breast milk for sample collection over a 24-hour period
- Willing to follow a meal plan for 5.5 months postpartum if assigned to postnatal intervention
- Able to participate in study procedures for 24 months postpartum
- Reside in Central Arkansas region
You will not qualify if you...
- Pre-existing conditions such as diabetes, hypertension, heart disease, or thyroid disorders
- Use of recreational drugs, tobacco, or more than one serving of alcohol per month
- Food allergies, intolerances, or preferences interfering with the meal plan
- Medical history including contraindications to breastfeeding (incompatible medications or supplements, substance use)
- Multiple pregnancy (twins or more)
- History of breast surgery or radiation
- Congenital defects
- Preeclampsia
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 37 weeks gestation until delivery
Participants assigned to the prenatal intervention group receive education and training on antenatal breastmilk expression (ABME) starting around 37 weeks of gestation. They will perform hand expression twice daily and bring colostrum samples to the first postnatal visit.
1 prenatal education session and 1 postnatal visit for sample collection
Duration - 5.5 months postpartum
Participants assigned to the postnatal intervention group follow a dietary program for 5.5 months postpartum designed to align with the Dietary Guidelines for Americans, including delivered meals and nutritionist consultations.
Monthly visits with nutritionist and meal delivery throughout intervention
Duration - From enrollment through 6 months postpartum
All participants receive standard prenatal and postnatal lactation support including education, videos, and interaction with certified lactation counselors as needed.
Multiple visits as needed with certified lactation counselors
Duration - Up to 6 months postpartum
Participants are monitored for breastfeeding outcomes, milk composition, and infant growth up to 6 months postpartum.
Regular visits for data collection up to 6 months postpartum
Trial Site Locations
Total: 2 locations
1
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Not Yet Recruiting
2
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Actively Recruiting
Research Team
A
Aline Andres, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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