Status:
RECRUITING
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Breastfeeding
Dietary Intervention
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 c...
Detailed Description
The American Academy of Pediatrics recommends exclusive breastfeeding for at least 6 months followed by continued breastfeeding with the introduction of complementary foods as long as desired. When st...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06929091
Start Date
November 7 2025
End Date
December 1 2029
Last Update
December 10 2025
Active Locations (2)
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1
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
2
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202