Recruiting

Breastfeeding Preparation

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT06929091

Conditions

Breastfeeding

Dietary Intervention

Milk Expression, Breast

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lactation Support and ABME

Lactation Support and meal plan

Lactation Support

Study Details

Brief 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.

Conditions

Breastfeeding

Dietary Intervention

Milk Expression, Breast

Study ID

NCT06929091

Start date

Nov 7, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lactation support group

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.

experimental: Lactation Support + Prenatal Intervention group

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

experimental: Lactation Support + Postnatal Intervention group

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

Interventions

Lactation Support and ABME

Participants randomized to this group will receive lactation support as group 1. They will also receive education and training (video and handout) on hand expression of colostrum, ABME technique, starting at \~ 37 weeks of gestation. They will have Q\&A session with a CLC to address individual concerns and reinforce proper technique. Participants will be asked to perform hand expression 2 times per day for 2-5 minutes, store the colostrum according to the instructions they will receive and bring the sample on the first postnatal study visit.

Lactation Support and meal plan

Participants randomized to this group will receive similar lactation support as group 1. They will also receive a 5.5-month dietary program postpartum, designed to align with the Dietary Guidelines for Americans. The plan emphasizes lean proteins, legumes, nuts, whole grains, fruits, vegetables, low-fat dairy, and healthy fats. Up to two daily meals (lunch and dinner) will be delivered as packaged, made-to-order meals. Breakfast items, wraps, and snacks (e.g., shakes) will be prepared by participants using whole foods provided by the facility, with a blender supplied if needed. Additional snacks and items will be given during study visits. Participants will be encouraged to follow the plan consistently, including outside the home, but may have one "flex" day per week to eat outside the plan. Compliance will be monitored with 24-hour recalls and consultations with a nutritionist at each visit.

Lactation Support

Participants randomized to this group will receive standard prenatal and postnatal lactation support, including prenatal breastfeeding education with handouts, videos and interaction with certified lactation counselors (CLC), as well as postpartum lactation support as needed by CLCs.

Primary outcome measure

  • Human Milk composition [ Time Frame: From birth to 6 months postpartum ]
  • Breastfeeding Initiation [ Time Frame: Birth to 2 weeks postpartum ]
  • Breastfeeding Duration [ Time Frame: From birth to 6 months ]

Central Contacts and Locations

Central contacts

Locations

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Principal Investigator:

Aline Andres, PhD

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • Breastfeeding
  • Human Milk
  • Obesity
  • Health Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-12-10.