The Lactation Cookie Study

Abstract

This repository contains the Statistical Analysis Plan, Data and Code for The Lactation Cookie Study. Journal article: Palacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 Mar 14:S0002-9165(23)46266-1. doi: 10.1016/j.ajcnut.2023.03.010. Epub ahead of print. PMID: 36921902. Study summary: Lactation cookies contain ingredients believed to stimulate the production of human milk. To date, there is very little evidence to support their effectiveness in increasing breast milk output. This double-blind randomized controlled trial aims to assess the effect of lactation cookies on objectively measured human milk production. In addition, this trial will evaluate changes in maternal perceived milk supply, and breastfeeding self-efficacy. To accomplish this aim, 176 exclusively breastfeeding mothers of 2-month-old infants will be recruited via social media and other online recruitment platforms. Eligible participants will receive a hospital-grade breast pump, and a kit that will include 30 neutral packages containing either lactation cookies (with galactagogue ingredients: oats, yeast, fenugreek) or control cookies, (with similar calorie content and presentation, but lacking the galactagogues); instructions on how to perform a validated milk expression protocol that will assess milk production rate; and a 60mL syringe to measure milk output from each breast from the last two pumping sessions. Participants will be asked to complete a form with pumping times and upload photographs of expression output from both breasts from the two last sessions. Prior to begin eating the cookies, the participants will be asked to complete a baseline survey and to complete the milk expression protocol. After completing baseline assessments, participants will be instructed to eat one daily package of cookies for 30 consecutive days. After finalizing the cookies, participants will be instructed to repeat the milk expression protocol and complete a post-intervention survey