Prenatal and postnatal strategies to improve breastfeeding for women with excess weight
Ready, Set, Nourish Study
This project will test whether prenatal hand expression of colostrum, a postnatal meal plan, and extra lactation support help pregnant women with overweight or obesity breastfeed more successfully.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Little Rock, Arkansas and 1 other locations) |
| Trial ID | NCT06929091 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls pregnant people with pre-pregnancy BMI ≥25 before 37 weeks and assigns them to combinations of antenatal breast milk expression, a structured postnatal meal plan, and lactation support. Participants will provide human milk samples over a 24-hour period, and those in the prenatal arm will be asked to express colostrum around 37 weeks; postnatal meal plan participants will follow the plan for 5.5 months. Investigators will track breastfeeding initiation and duration, milk composition, and infant growth and development through 24 months postpartum. People with medical contraindications to breastfeeding, certain preexisting conditions, or substance use exclusions are not eligible.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a singleton pregnancy under 37 weeks, pre-pregnancy BMI ≥25, who plan to breastfeed and reside in the Central Arkansas region are ideal candidates.
Not a fit: People with medical contraindications to breastfeeding, preexisting conditions like diabetes or thyroid disease, tobacco or recreational drug use, or unwillingness to express milk or follow the meal plan are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase breastfeeding initiation and duration and improve milk composition and infant nutrition for women with overweight or obesity.
How similar studies have performed: Prior studies show that extra lactation support and education can increase breastfeeding initiation in women with overweight or obesity, but evidence is limited for antenatal hand expression and targeted postnatal dietary interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 1 other locations
- Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States (Not_yet_recruiting)
- Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Aline Andres, PhD.
- Email: andresaline@uams.edu
- Phone: 501-364-3301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.