Prenatal and postnatal strategies to improve breastfeeding for women with excess weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study enrolls pregnant people with pre-pregnancy BMI ≥25 before 37 weeks and assigns them to combinations of antenatal breast milk expression, a structured postnatal meal plan, and lactation support. Participants will provide human milk samples over a 24-hour period, and those in the prenatal arm will be asked to express colostrum around 37 weeks; postnatal meal plan participants will follow the plan for 5.5 months. Investigators will track breastfeeding initiation and duration, milk composition, and infant growth and development through 24 months postpartum. People with medical contraindications to breastfeeding, certain preexisting conditions, or substance use exclusions are not eligible.

Why it matters

Who can join: the full rules

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

Where it's running

• Arkansas Children's Nutrition Center
  Little Rock, Arkansas, United States Recruiting

Study contacts

• Study coordinator: Aline Andres, PhD.
• Email: andresaline@uams.edu
• Phone: 501-364-3301

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Earlier use of an electric breast pump to maximize milk in preterm babies

  This study tests whether starting a double electric breast pump earlier (at birth) helps mothers of very preterm infants produce more milk by day 14.

  Recruiting National Maternity Hospital, Ireland · Dublin, Co. Dublin and 2 other locations · NCT07908238

• Methyl-Donor Rich Diet in the Postpartum Period

  Researchers will test whether a methyl-donor‑rich diet in the first weeks after birth helps reduce maternal depression and supports breastfeeding and infant growth.

  Recruiting Istanbul University - Cerrahpasa · Bursa, Orhaneli̇ · NCT07887178

• Alcohol, Breast Milk, and Metabolism in Lactating Women

  This study tests whether breast tissue locally metabolizes alcohol by comparing alcohol-related markers in blood and breast milk from lactating women after low-level alcohol exposure.

  Recruiting University of Illinois at Urbana-Champaign · Urbana, Illinois · NCT07779967

• Relaxation audio during breastfeeding to help newborn growth and mom’s well-being

  Researchers will test if listening to a relaxation audio during breastfeeding helps LBW babies grow and reduces maternal stress in a Ugandan setting.

  Recruiting University of California, San Francisco · Kampala · NCT07774793

• Breastfeeding education with web portal and app-supported counseling

  This trial tests whether added breastfeeding education plus digital support helps first-time mothers start and continue breastfeeding when they are near delivery.

  Recruiting Aydin Adnan Menderes University · Bursa · NCT07721311

• Grandparent-informed breastfeeding support for new mothers

  This study tests whether training grandparents and fathers to support breastfeeding can help new mothers start breastfeeding within the first hour and maintain exclusive breastfeeding for six months.

  Recruiting Nigde Omer Halisdemir University · Niğde · NCT07713160

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.