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Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)

Ready, Set, Nourish Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for pregnant women who had excess weight before pregnancy and want to breastfeed. It tests whether collecting early breast milk by hand during pregnancy helps with breastfeeding after birth. It also looks at how a mother's diet affects what is in her breast milk and her baby's growth and development.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and live in Central Arkansas.
  • Be less than 37 weeks pregnant with one baby.
  • Have had a body mass index (BMI) of 25 or higher before pregnancy. BMI is a measure based on height and weight.
  • Be interested in breastfeeding.
  • Be willing to collect colostrum (early breast milk) starting around week 37 if assigned to that study group.
  • Be willing to collect breast milk samples over a 24-hour period.
  • Be willing to follow a meal plan for 5.5 months after birth if assigned to that study group.
  • Be able to take part in study activities for the first 24 months after birth.

Who can't join

  • Existing health conditions, such as diabetes, high blood pressure, heart disease, or thyroid problems.
  • Use of recreational drugs, tobacco, or two or more servings of alcohol per month.
  • Food allergies, food intolerances, or food choices that prevent following the meal plan.
  • A medical history that makes breastfeeding unsafe, including use of certain medicines, supplements, or substances.
  • Past breast surgery or radiation treatment.
  • Birth defects.
  • Preeclampsia, a pregnancy condition involving high blood pressure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

AR