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RECRUITINGINTERVENTIONAL

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

Ready, Set, Nourish Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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