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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT06929091
Status
Recruiting
Apply to this trial

Conditions

  • Breastfeeding
  • Dietary Intervention
  • Milk Expression, Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 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 — 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.

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Human Milk composition [ Time Frame: From birth to 6 months postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arkansas Children's Nutrition CenterLittle RockArkansas72202
Elizabeth R Hayes
[email protected]
501-364-3309
Aline Andres, PhD (PRINCIPAL_INVESTIGATOR)
Sarah Sobik, MD (SUB_INVESTIGATOR)
Andrew Morris, PhD (SUB_INVESTIGATOR)
Colin Kay, PhD (SUB_INVESTIGATOR)
Xiawei Ou, PhD (SUB_INVESTIGATOR)
Taren Swindle, PhD (SUB_INVESTIGATOR)
Arkansas Children's Nutrition CenterLittle RockArkansas72202
Elizabeth R Hayes
[email protected]
501-364-2809
Aline Andres, PhD (PRINCIPAL_INVESTIGATOR)
Sarah Sobik, MD (SUB_INVESTIGATOR)
Colin Kay, PhD (SUB_INVESTIGATOR)
Xiawei Ou, PhD (SUB_INVESTIGATOR)
Taren Swindle, PhD (SUB_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Nutrition Center· Little Rock, AR

Related Studies