跳至主要内容
临床试验/NCT06929091
NCT06929091招募中不适用

Ready, Set, Nourish Study

Arkansas Children's Hospital Research Institute3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
3
主要终点
Human Milk composition

研究概览

简要总结

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.

详细描述

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 started during the first hour after birth, breastfeeding is more successful. In Arkansas, 74% of infants are breastfed at some point and 24% are exclusively breastfed through 6 months. As such, human milk serves as the primary source of nutrition for many infants. Current research demonstrates lower breastfeeding initiation and shortened duration of breastfeeding in women with obesity. Barriers are present to supporting women with obesity and overweight to successfully breastfeed and meet the breastfeeding recommendations. One barrier is that women with pre-pregnancy obesity have an increased risk of delayed lactogenesis II.

It is unclear what the most effective strategies may be to support women with obesity and overweight to meet their breastfeeding goals. Specifically, there is lack of evidenced-based literature for women with overweight and obesity who want to breastfeed. Findings suggest that targeted interventions in early pregnancy can help ameliorate the effects of obesity and poor breastfeeding initiation as an innovative opportunity to improve breastfeeding rates in this group. Recent research shows that women with overweight and obesity who receive additional support and education to breastfeed from a physician increase their likelihood to initiate breastfeeding. Educational interventions and support, specifically from health professionals tailored towards women with overweight and obesity may improve breastfeeding initiation, exclusivity, and duration.

Antenatal breastmilk expression (ABME) is an innovative technique of colostrum expression in the later weeks of pregnancy (36 weeks to birth) that can be used as a targeted intervention to support women at risk of not breastfeeding or early breastfeeding cessation. ABME starting at 37 weeks gestation has been shown to have the potential to hasten the onset of lactogenesis II, can improve postpartum engorgement, decrease need for supplementation in infants, and improve exclusive breastfeeding duration up to six months postpartum. The limited research on ABME has been mostly in regards to mothers with gestational diabetes and/or for reduction of newborn hypoglycemia. In a recently published systematic review, the findings demonstrated that there is limited evidence and few research studies that have tested the feasibility of antenatal breastmilk expression. Based upon these reviews and the limited evidence from small qualitative studies, more research is needed regarding the efficacy, feasibility, and acceptability of ABME to help women with excessive weight to meet their breastfeeding goals.

Breastfeeding can play a significant role in improving maternal and child outcomes, especially in preventing childhood obesity. Epidemiological and experimental studies support the influence mother's diet in milk composition via several pathways that modulate direct and indirectly certain milk components. Dietary habits, and excessive weight among other factors has been associated with compositional changes in human milk including increased human milk concentrations of leptin, insulin, C-reactive protein, fat, protein and some oligosaccharides. All of these have also been associated with elevated infant fat mass index, even after considering daily human milk volume intakes or adjusting for maternal body mass index and birth weight. In the United States, more than half of women of childbearing age are with excessive weight, which may affect their milk composition and be an early programming of health in later life.

Despite such evidence, no specific dietary recommendations currently exist for lactating women with excessive weight to promote optimal breastfeeding outcomes, human milk composition, infant growth, and infant body composition. In fact, the current report of the Dietary Guidelines for Americans Advisory Committee (2025) pointed to numerous gaps in knowledge that limited their ability to provide strong dietary recommendations for pregnant and lactating women with excessive weight. Therefore, understanding the associations between human milk composition and developmental outcomes can lead to strategies for modifying maternal dietary habits when needed. Considering that most factors happening in the first 1000 days of life represent risk for the development of later childhood obesity are modifiable, a study that will investigate quantitative and qualitative the role of maternal diet on breast milk composition, associate maternal and infant metabolic state and anthropometric characteristics can contribute with evidences to next recommendations for these public.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Human Milk composition

时间窗: From birth to 6 months postpartum

Human Milk composition will be analyzed from milk samples collected at the postpartum visits (2 weeks, 1, 2, 3, 4, 5, and 6 months). Standardized collection and laboratory procedures described in the study protocol will be followed. Samples will be stored and analyzed at the Arkansas Children's Nutrition Center to evaluate milk composition over time across study groups.

Breastfeeding Initiation

时间窗: Birth to 2 weeks postpartum

Breastfeeding initiation (defined as any breastfeeding within the first 24 hours after delivery) will be assessed using standardized Lactation Medical History questionnaire. Data will be obtained at first postpartum study visit, occurring at approximately 2 weeks postpartum. This assessment will provide quantitative data on breastfeeding practice across all study groups.

Breastfeeding Duration

时间窗: From birth to 6 months

Breastfeeding duration (measured in cumulative days of any breastfeeding and exclusive breastfeeding) will be assessed using a standardized Lactation Medical History questionnaire. Data will be obtained at all postpartum study visits occurring approximately at 0.5, 1, 2, 3, 4, 5, and 6 months postpartum. These assessments will provide quantitative data on breastfeeding practices across all study groups.

次要结局

  • Delay in Onset of Lactogenesis II(From delivery to 1 month postpartum.)
  • Breastfeeding Self-Efficacy Scale- Short(From birth to 2 weeks postpartum.)
  • Breastfeeding Exclusivity up to 6 Months(From birth through 6 months postpartum.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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