RecruitingNot ApplicableNCT06548828

Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes

Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)

Sponsor

George Washington University

Enrollment

324 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Gestational Diabetes Mellitus in Pregnancy Glucose Intolerance During Pregnancy Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Summary

The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Control Intervention and a behavioral approach called NNS Restriction Intervention for people with gestational diabetes mellitus in pregnancy, glucose intolerance during pregnancy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNNS Restriction Intervention

Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health. Provide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS. Emphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead. Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages. Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS

BEHAVIORALControl Intervention

Counsel about best practices for home safety and babyproofing. Provide a detailed booklet to take home, which will provide information about home safety and baby proofing. Educate about common causes of accidental infant and young child injuries or death. Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.