Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With … (NCT06929091) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
United States240 participantsStarted 2025-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Human Milk composition
Timeframe: From birth to 6 months postpartum
2
Breastfeeding Initiation
Timeframe: Birth to 2 weeks postpartum
3
Breastfeeding Duration
Timeframe: From birth to 6 months
Trial details
NCT IDNCT06929091
SponsorArkansas Children's Hospital Research Institute