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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorArkansas Children's Hospital Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lactation Support and ABME

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Lactation support groupExperimental treatment 1 intervention
Group B: Lactation Support + Prenatal Intervention groupExperimental treatment 1 intervention
Group C: Lactation Support + Postnatal Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From birth to 6 months postpartum
2

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.

Time frame
Birth to 2 weeks postpartum
3

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.

Time frame
From birth to 6 months

Secondary outcomes

1

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.

Time frame
From delivery to 1 month postpartum.
2

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).

Time frame
From birth to 2 weeks postpartum.
3

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).

Time frame
From birth through 6 months postpartum.

Other outcomes

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