Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06929091
NA

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

Sponsor: Arkansas Children's Hospital Research Institute

View on ClinicalTrials.gov

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.

Official title: Ready, Set, Nourish Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-11-07

Completion Date

2029-12-01

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Locations (2)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States