Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Ready, Set, Nourish Study
Arkansas Children's Hospital Research Institute
240 participants
Nov 7, 2025
INTERVENTIONAL
Conditions
Summary
This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can help prepare a mother to breastfeed after she has her baby and about how her diet affects the composition of her breast milk and her baby's growth and development.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants randomized to this group will receive lactation support as group 1. They will also receive education and training (video and handout) on hand expression of colostrum, ABME technique, starting at \~ 37 weeks of gestation. They will have Q\&A session with a CLC to address individual concerns and reinforce proper technique. Participants will be asked to perform hand expression 2 times per day for 2-5 minutes, store the colostrum according to the instructions they will receive and bring the sample on the first postnatal study visit.
Participants randomized to this group will receive similar lactation support as group 1. They will also receive a 5.5-month dietary program postpartum, designed to align with the Dietary Guidelines for Americans. The plan emphasizes lean proteins, legumes, nuts, whole grains, fruits, vegetables, low-fat dairy, and healthy fats. Up to two daily meals (lunch and dinner) will be delivered as packaged, made-to-order meals. Breakfast items, wraps, and snacks (e.g., shakes) will be prepared by participants using whole foods provided by the facility, with a blender supplied if needed. Additional snacks and items will be given during study visits. Participants will be encouraged to follow the plan consistently, including outside the home, but may have one "flex" day per week to eat outside the plan. Compliance will be monitored with 24-hour recalls and consultations with a nutritionist at each visit.
Participants randomized to this group will receive standard prenatal and postnatal lactation support, including prenatal breastfeeding education with handouts, videos and interaction with certified lactation counselors (CLC), as well as postpartum lactation support as needed by CLCs.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06929091