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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Lactation Support and ABME
Other interventionParticipants 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 interventionParticipants 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 interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Delay in Onset of Lactogenesis II
Onset of copious milk secretion (Lactogenesis II) will be assessed by maternal self-report at the first postpartum study visits. Delay in Lactogenesis II will be defined as onset ocurring more than 72 hours after delivery. Data will be collected through the Postnatal Lactation Medical History questionnaire.
Breastfeeding Self-Efficacy Scale- Short
Maternal confidence in breastfeeding ability will be evaluated using the Breastfeeding Self-Efficacy Scale-Short Form. The Breastfeeding Self-Efficacy Scale - Short Form measures a mother's confidence in her ability to breastfeed. It consists of 14 items rated on a 5-point Likert scale (1=not at all confident, 2= not very confident, 3=sometimes confident, 4= confident, 5= always confident). Possible range: minimum 14 (if all responses=1) and maximum 70 (if all responses=5). Higher scores (closer to 70) indicate greater breastfeeding self-efficacy (i.e., mother is confident in breastfeeding, more likely to continue breastfeeding and less likely to supplement or wean early). Moderate scores (40-55) indicate variable or developing confidence (i.e., mother may need guidance, and support). Low scores (closer to 14-39) indicate low breastfeeding self-efficacy (i.e., mother may have concerns, or challenges). The questionnaire will be administered at the first postpartum visit (2 weeks).
Breastfeeding Exclusivity up to 6 Months
Exclusive breastfeeding status will be determined through maternal self-report using the Postnatal Lactation Medical History questionnaire. Exclusivity will be defined as no other liquids or solids except for prescribed vitamins or medications given to the infant. Assessments will occur at each postpartum visit ( 0.5, 1, 2, 3, 4, 5, and 6 months).
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