Prenatal and Postnatal Interventions for Breastfeeding

(RSN Trial)

Overseen By Aline Andres, PhD.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Must not be taking: Recreational drugs, Tobacco, Alcohol

Disqualifiers: Diabetes, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with excessive weight have better breastfeeding experiences. Researchers are testing whether hand expression of breast milk during pregnancy (a prenatal intervention) can prepare mothers for breastfeeding and how a mother's diet affects her breast milk and her baby's growth. There are three groups: one with only lactation support, one with lactation support plus prenatal milk expression, and one with lactation support plus a postpartum diet plan. Women who are less than 37 weeks pregnant with a single baby, have a pre-pregnancy weight that results in a higher body mass index (BMI), and are interested in breastfeeding might be a good fit. Participants must live in Central Arkansas and be willing to follow study procedures for two years. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance breastfeeding experiences for women with higher BMI.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with pre-existing conditions and medications incompatible with breastfeeding.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that expressing breast milk during pregnancy is generally safe for most women. One study found that 82% of women expressed milk at least seven times a week without major issues. It is also considered safe for women with diabetes who have a low risk of complications.

Regarding dietary changes after birth, evidence suggests that breastfeeding support can enhance breastfeeding success. Some studies found it aids in initiating and continuing breastfeeding, although results may vary.

These activities are well-tolerated and focus on natural processes like expressing breast milk and following dietary advice, which are generally safe for most women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support breastfeeding through both prenatal and postnatal interventions. Unlike traditional approaches that often focus solely on postnatal lactation support, this trial investigates the potential benefits of antenatal breast milk expression (ABME) and early colostrum collection. By combining these with dietary guidance postpartum, the study aims to enhance breastfeeding outcomes and maternal nutrition. This comprehensive approach could provide new insights into optimizing breastfeeding practices and improving health for both mothers and their infants.

What evidence suggests that this trial's interventions could be effective for improving breastfeeding outcomes?

This trial will compare different interventions to support breastfeeding. Research has shown that expressing breast milk before birth (aBME), provided to participants in the Lactation Support + Prenatal Intervention group, can help mothers initiate and sustain breastfeeding. This method is safe and effective, particularly for women without serious health issues. Participants in the Lactation Support + Postnatal Intervention group will receive support after birth, which studies have found can encourage more mothers to continue breastfeeding for months. This group will also follow a postpartum dietary program, as dietary changes after childbirth can improve health, such as aiding with weight and blood sugar levels. These findings suggest that both prenatal and postnatal interventions can enhance breastfeeding experiences. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

The Ready, Set, Nourish Study is for pregnant women over 18 with a BMI ≥ 25 kg/m2 who plan to breastfeed and live in Central Arkansas. Participants must be willing to express colostrum prenatally if asked and follow a meal plan postpartum. Exclusions include certain medical conditions, substance use, food allergies that conflict with the meal plan, history of breast surgery or radiation.

Inclusion Criteria

Able to engage in study procedures for the first 24 months postpartum

Planning to breastfeed for the first 6 months of life

Willing to express colostrum from around 36 weeks of pregnancy if randomized to the prenatal intervention group

Exclusion Criteria

Medical history including any contraindication to breastfeeding (medications or supplements incompatible with breastfeeding, substance use)

Multiparous pregnancy

Food allergies, intolerances, or preferences interfering with the meal plan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive instructions on Antenatal Breast Milk Expression (ABME) and have collection of colostrum before delivery

From 36 weeks gestation to birth

Regular visits as needed for instruction

Postnatal Intervention

Participants follow a personalized Mediterranean-style meal plan for 6 months

6 months

Monthly visits for dietary monitoring and support

Follow-up

Participants are monitored for breastfeeding outcomes, human milk composition, and infant growth and development

Up to 24 months

Periodic visits for assessment

What Are the Treatments Tested in This Trial?

Interventions

• Postnatal Intervention
• Prenatal Intervention

Trial Overview This study tests whether expressing colostrum during pregnancy (prenatal intervention) and adhering to a specific diet after birth (postnatal intervention) improve breastfeeding outcomes. Women will be randomly assigned to these interventions to see how they affect milk composition and baby's growth.

How Is the Trial Designed?

Group I: Lactation support group Experimental Treatment 1 Intervention

This group helps researchers compare the effects of the intervention by serving as a baseline for what would happen without ABME technique or a dietary intervention.

Group II: Lactation Support + Prenatal Intervention group Experimental Treatment 1 Intervention

Participants in this group will receive instructions on Antenatal Breast Milk Expression (ABME) and have collection of colostrum before delivery.

Group III: Lactation Support + Postnatal Intervention group Experimental Treatment 1 Intervention

Participants will receive lactation support and a 5.5-month postpartum dietary program aligned with the Dietary Guidelines for Americans.

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Published Research Related to This Trial

Only 21% of the 108 primigravida mothers studied received antenatal counseling on breastfeeding, indicating a significant gap in support for new mothers during pregnancy.

Mothers who received counseling had better awareness about breastfeeding, but overall knowledge about correct techniques and breastfeeding during illness was still lacking, highlighting the need for improved education and support in antenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antenatal counseling on breastfeeding -- is it adequate? A descriptive study from Pondicherry, India. Dhandapany, G., Bethou, A., Arunagirinathan, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11013075/

Effectiveness of a Postpartum Breastfeeding Support ... The results showed that at 4 months postpartum there was a higher prevalence of breastfeeding in the intervention group compared to formula feeding (p = 0.01), ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624003456

Effects of Breastfeeding Promotion Intervention and Dietary ... The Diet treatment resulted in statistically significant and favorable changes in weight, fasting glucose, and insulin concentrations as well as percent body ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2832390

Interventions to Support Breastfeeding: Updated Evidence ... A meta-analysis of 8 trials (n = 4607) found no statistically significant association with receiving a breastfeeding support intervention and ...

4. internationalbreastfeedingjournal.biomedcentral.com internationalbreastfeedingjournal.biomedcentral.com/articles/10.1186/s13006-021-00396-y

Effect on breastfeeding practices of providing in-home ... This pre/post intervention study will examine the effect on breastfeeding outcomes of an evidence-based in-home lactation support intervention provided through ...

5. data.ers.usda.gov data.ers.usda.gov/FANRP-research-reports-articles-database.aspx?type=2&fanrp_no=61

Food and Nutrition Assistance Research Reports Database The most effective breastfeeding interventions include in-person and individualized lactation support spanning the pre-and postnatal periods.

6. cdc.gov cdc.gov/breastfeeding-data/mpinc/supporting-evidence.html

mPINC™ Survey Supporting Evidence | Breastfeeding Data These outcomes include improved breastfeeding initiation, breastfeeding exclusivity, and breastfeeding duration.1-4. Results also show a dose-response ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612340/

Evidence reviews for approaches and interventions for ... - NCBI The aim of this review is to identify what interventions are effective in maintaining breastfeeding beyond 8 weeks after birth.

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1473086/full

Postnatal counseling promotes early initiation and ... The intervention group showed a significantly higher proportion of newborns (53%) receiving frequent breastfeeding compared to the control group ...