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

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, we 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.

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 prenatal and postnatal breastfeeding intervention safe for humans?

The research does not report any safety concerns for prenatal and postnatal breastfeeding interventions, suggesting they are generally safe for humans. ^{1 2 3 4 5}

How does the Prenatal Intervention treatment for breastfeeding differ from other treatments?

The Prenatal Intervention treatment is unique because it focuses on providing education and support before and after birth to increase breastfeeding initiation and duration. Unlike other treatments, it emphasizes recurrent, individual, and technology-based education programs to offer evidence-based guidance, which is not typically part of standard prenatal care. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Prenatal and Postnatal Interventions for Breastfeeding?

Research shows that prenatal breastfeeding education can significantly increase the success of breastfeeding and improve mothers' perceptions of their infants. Additionally, combining information, guidance, and support during both prenatal and postnatal periods has been effective in extending breastfeeding duration. ^{1 10 11 12 13}

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: Prenatal Intervention Experimental Treatment 1 Intervention

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

Group II: Postnatal Intervention Experimental Treatment 1 Intervention

Participants in this group will follow a personalized Mediterranean-style meal plan for 6 months.

Group III: Standard of Care Active Control 1 Intervention

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

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. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of a breastfeeding coaching program on growth and neonatal jaundice in late preterm infants in South Korea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Extending breastfeeding duration through primary care: a systematic review of prenatal and postnatal interventions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding Motivation Predicts Infant Feeding Intention and Outcomes: Evaluation of a Novel Adaptation of the Treatment Self-Regulation Questionnaire. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of prenatal breastfeeding education on breastfeeding success and maternal perception of the infant. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The effect of prenatal counseling on breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding: a randomized controlled clinical trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of breastfeeding promotion on the infertile postpartum period. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of breastfeeding promotion on the infertile postpartum period. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Incorporating breastfeeding education into prenatal care. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Antenatal counseling on breastfeeding -- is it adequate? A descriptive study from Pondicherry, India. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evidence-based interventions to support breastfeeding. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The effect of a breastfeeding support programme on breastfeeding duration and exclusivity: a quasi-experiment. [2020]

13. England pubmed.ncbi.nlm.nih.gov

A systematic review of professional support interventions for breastfeeding. [2022]