Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Recruiting · NCT06929091 · Interventional (participants receive a specific treatment) · Lead sponsor: Arkansas Children's Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Lactation SupportLactation Support and ABMELactation Support and meal plan
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Arkansas Children's Nutrition Center - Little Rock, Arkansas, United States
- Arkansas Children's Nutrition Center - Little Rock, Arkansas, United States