10 Participants Needed

Heat Exposure for Lactation

MC
Overseen ByMargaret C Morrissey-Basler, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Providence College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercising in hot conditions (heat exposure) might affect breast milk production and energy content. It involves lactating women who are breastfeeding or pumping for babies aged 6 weeks to 24 months. Participants will exercise in both hot and comfortable environments to assess if heat influences milk quantity and quality. The trial aims to determine if heat stress reduces milk production or alters its nutritional makeup. As an unphased trial, it offers participants the chance to contribute to important research that could benefit breastfeeding mothers worldwide.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a chronic disease like diabetes or hypertension, you may not be eligible to participate.

What prior data suggests that heat exposure during exercise is safe for lactating women?

Research shows that extreme heat can affect pregnant and breastfeeding women in various ways. Studies have found that extreme heat can lead to issues like low birth weight and early birth. However, limited information exists on how heat affects breastfeeding mothers during exercise.

Healthy adults can generally handle short periods of exercise in the heat if they stay hydrated. Exercising safely in warm conditions involves monitoring body temperature and maintaining hydration. In this trial, participants will exercise in a controlled setting, with heart rate and temperature closely monitored. This setup aims to minimize potential risks.

Prospective participants should discuss any concerns with the research team. The team can provide more details on how they ensure participant safety during the study.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how heat exposure might affect lactation differently than standard methods, which typically involve lifestyle and dietary adjustments. This approach is unique as it investigates the impact of heat exposure in an environmental chamber during exercise, a novel angle that hasn't been widely studied in this context. By examining how heat exposure influences milk production, researchers hope to uncover new insights that could enhance breastfeeding support strategies. This could potentially offer a simple, non-invasive method to improve lactation outcomes for mothers.

What evidence suggests that heat exposure is effective for altering breast milk production and composition?

Research shows that hot weather can affect breastfeeding. Some studies have found that mothers produce less breast milk during hot, humid seasons. In very warm places, breastfed babies might get dehydrated due to reduced milk production. Extreme heat can also lead to shorter breastfeeding times and less milk supply. This trial will compare the effects of heat exposure during exercise with a thermoneutral condition. These findings suggest that heat stress might lower breast milk production and alter its composition after exercising in hot conditions.12567

Who Is on the Research Team?

MC

Margaret C Morrissey-Basler, PhD

Principal Investigator

Providence College

Are You a Good Fit for This Trial?

This trial is for lactating women who are exclusively breastfeeding. They should be able to perform moderate exercise and tolerate heat exposure. Women with health conditions that could affect their milk production or composition, or those unable to complete the exercise protocol in hot and temperate conditions, may not qualify.

Inclusion Criteria

Currently breastfeeding or pumping expressed breastmilk for their 6-week to 24-month infants
Delivered their infants between 37-42 weeks of gestational age
I am between 18 and 45 years old.

Exclusion Criteria

Obstetrical complications during pregnancy
Multiple gestation
I have a long-term illness like diabetes or high blood pressure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Baseline Testing

Baseline testing includes anthropometric measurements and metabolic heat production testing

1 visit
1 visit (in-person)

Experimental Trials

Participants complete two exercise trials: one in a hot environment and one in a thermoneutral environment, each lasting 60 minutes

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for breast milk production and composition changes post-exercise

24 hours post each exercise trial
Home-based monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Heat exposure
Trial Overview The study tests how acute exercise in a hot environment (36°C, 40% humidity) versus a temperate one (20°C, 20% humidity) affects breast milk production and its energy content over 24 hours. Participants will walk on a treadmill at an intensity based on their metabolic rate and have their breast milk analyzed.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Heat exposureExperimental Treatment1 Intervention
Group II: Thermoneutral ConditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Providence College

Lead Sponsor

Trials
1
Recruited
20+

Citations

A systematic review of hot weather impacts on infant feeding ...3. Breastmilk output has been shown to decrease in the wet season in some studies. 4. Fears of diarrhoeal disease in their infants in the late summer months ...
Climate Change and the Health of Pregnant, Breastfeeding ...Extreme heat exposure in pregnant women has been associated with low birth weight, preterm birth, and infant mortality. Pregnant, breastfeeding ...
The Climate Crisis and Breastfeeding: Opportunities for ...In the setting of chronic heat exposure, breastfed newborns can suffer from dehydration, both from free water loss and insufficient human milk ...
How do high ambient temperatures affect infant feeding ...The population experienced year-round high temperatures (daily mean temperature range=22.6°C–33.7°C). Breastfeeding decreased by 2.3 minutes/day.
Impact of Climate Change on Human LactationResearch has found that heat exposure during pregnancy can lead to adverse outcomes such as preterm birth, low birth weight, and stillbirth ( ...
Analysis of Heat Exposure During Pregnancy and Severe ...So far, extreme heat has been associated with many adverse obstetric outcomes, including preterm birth, premature rupture of membranes, low ...
How is maternal, newborn, and child health addressed in ...A 2020 literature review and meta-analysis [9] estimated a 5% increase in the odds of stillbirth and premature birth with each 1°C temperature ...
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