Can lactation cookies boost our breast milk supply?

Study Overview

Caring for an infant is demanding, and breastfeeding can become cumbersome and stressful, especially if we are concerned about our own milk supply. Many of us think that our milk is not sufficient to cover the nutritional needs of our babies, and for this reason, many moms decide to wean the babies prematurely, before babies turn 6 months of age. 
 
We want to find out if lactation cookies can increase breast milk production. Additionally, we will also investigate associations between breast milk composition and infant sleep and behavior and we need your help!
 
IF YOU HAVE A BABY UNDER 1 MONTH OF AGE, YOU MAY BE ELIGIBLE!
 
If you are eligible, a 1-month cookie supply will be provided, and compensation as you complete the study activities. 

Study Description

The study will begin when you take your infant to the 2-month pediatrician’s visit and will occur from the comfort of your own home. All study procedures will be done by you, you will receive the study materials via mail, and most communications will occur via email unless you explicitly want to call us or text us. 
 
About 2 weeks prior to your child's 2-month birthday visit, we will send you a pre-baseline survey to confirm eligibility. If still eligible, you will be randomized into a group that will receive cookies that may have some ingredients thought to increase breast milk production. The study kit and a hospital strength electric breast pump will be shipped at this time. 
 
1.You will exclusively breastfeed for 1 month after starting the study. You should not use formula or eat lactation cookies within the 2 weeks prior to the beginning of the study or during the study. You also cannot consume any other lactation boosting items (other cookies, bars, drinks, etc.) while in this study.
 
2.You will eat one bag of commercially available cookies every day for 30 consecutive days. One bag of cookies is about 2 OZ and contains between 8 to 10 cookies.  
 
3.  We will ask you to complete several online surveys about you and your baby at 5 different time points: 
·         We will ask you some sociodemographic information, breastfeeding goals, and your weight before pregnancy and your last weight collected before giving birth.  
·         You will have to fill in a short survey 2 weeks before beginning the study. 
·         Within 3 days before you begin eating the cookies, you will complete questionnaires (perception of breast milk production, breastfeeding practices, breastfeeding self-confidence. We will also ask about the baby’s sleep, behaviors, feeding practices, and the following information from your baby’s birth and 2-month well-child visit: weight, height, and head circumference. A food frequency questionnaire and a mental wellness survey. we will also ask you to measure your weight with your personal weight scale. Completing the baseline surveys will take you about 1 hour to 1:20 minutes in total. Completing the end-line survey will take you about 20 minutes.
·         The day before or the same day you attend your baby’s 2-month well-child visit (before starting to eat the cookies) you will collect a drop of your first-morning breast milk (while fasting) on an absorbent paper, let air dry, store it in the envelope, and put in the mail. Within this timeframe, you will complete the breast milk expression instructions detailed below IN THE MORNING. You will also have access to a handout to help with the breast milk expression process.
·         Throughout the month, we will have you check-in and confirm that you are eating the cookies daily. You will receive an email every week that links to a very brief survey.
·         Within 2 days of finishing the cookies, you will complete surveys about breast milk perception, practices and confidence, breastfeeding goals, infant feeding practices, and your mental wellness. Only a few of the same surveys you completed before starting to eat the cookies). 
·         The day you finish the cookies (1-month later) we will ask you to do the breast milk expression protocol again at a similar time when you did it at baseline and to measure your weight again (preferably in the morning). 
Breast milk expression protocol: 
 
 You will use the provided electric breast pump and follow a breastmilk expression instruction hourly for 4 consecutive hours. Before starting, please ensure you have a reserve of expressed milk so that you can feed your baby in case the baby gets hungry during this time. 
 
1)The first expression: is to empty your breasts. You can feed your baby if desired, and after finishing, express both breasts with a breast pump until breasts are empty. We will ask you to set a 1h timer or alarm and to record the time. 
 
2)The second expression (60 minutes later): you will be asked to express milk with the pump from both breasts until the breasts are empty and record the time when you finish pumping.
From now on (3rd and 4th expressions), we will need to measure your milk volume, so please refrain from feeding your baby from the breast, and instead use expressed breast milk if the baby gets hungry. We will ask you to set a 1h timer or alarm. Record the time. IMPORTANT: if you are pumping each breast separately, set the 1-hour timer when you finish pumping the first breast. 
 
3)The third expression (60 minutes later): you will express milk from both breasts until breasts are empty. Record the time when you finish and set a 1-hour alarm. In the end, you will place the milk into a 60 mL plastic syringe and take a photo of the measurement from each breast. We will ask you to set a 1h timer or alarm. 
 
4)The fourth expression (60 minutes later): you will express milk from both breasts until breasts are empty. In the end, you will place the milk into a 60 mL plastic syringe and take a photo of the measurement from each breast. Record the time.
 
5)Once you have finished and have the 4 photos, please upload the photos in the respective file in the online survey. (You will receive an email link to the breast milk expression survey). 
 
6)If you are pumping each breast separately, set the times when you finish pumping the first breast. 
 


  • IRB Number: 10036
  • Research Study Identifier: TX11338
  • Principal Investigator: Ana Palacios

Recruitment Status

Closed
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If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.