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

NCT06929091 | Recruiting

• 1 other identifier: 298382
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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

Keywords

Breastfeeding; Human Milk; Obesity; Health Diet

Outcome Measures

Primary Outcomes (3)

• Human Milk composition

  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.

  From birth to 6 months postpartum

• Breastfeeding Initiation

  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.

  Birth to 2 weeks postpartum

• Breastfeeding Duration

  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.

  From birth to 6 months

Secondary Outcomes (3)

• 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.

Study Arms (3)

Lactation support group

EXPERIMENTAL

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.

Other: Lactation Support

Lactation Support + Prenatal Intervention group

EXPERIMENTAL

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

Other: Lactation Support and ABME

Lactation Support + Postnatal Intervention group

EXPERIMENTAL

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

Other: Lactation Support and meal plan

Interventions

Lactation Support and ABME OTHER

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 + Prenatal Intervention group

Lactation Support and meal plan OTHER

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 + Postnatal Intervention group

Lactation Support OTHER

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.

Lactation support group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (2)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

NOT YET RECRUITING

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression; Obesity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aline Andres, PhD.

CONTACT

501-364-3301; andresaline@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)