Actively Recruiting
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
Led by George Washington University · Updated on 2026-02-18
324
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
G
George Washington University
Lead Sponsor
C
Children's Hospital Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how consuming non-nutritive sweeteners (NNS) during pregnancy and breastfeeding might affect infant obesity risk and heart health. The study focuses on pregnant women who regularly consume NNS and looks at how limiting NNS intake during pregnancy and/or lactation influences the baby's body fat, the mother's blood sugar during pregnancy, and the baby's gut bacteria and metabolism. The findings could help guide recommendations for NNS use in pregnancy and breastfeeding to support better health for mothers and babies. Participants are assigned to one of three groups: continue usual NNS consumption throughout pregnancy and lactation, restrict NNS only during lactation, or restrict NNS during both pregnancy and lactation. The NNS restriction involves education about NNS and obesity risks, handouts with foods and drinks to avoid, weekly reminders, and bi-weekly shipments of unsweetened beverages as alternatives. The control group receives education on home safety and babyproofing with weekly reminders. During the study, infants' body fat is measured at 1 and 6 months old, while mothers undergo blood sugar tests at 28 weeks gestation and postpartum. Researchers also track infants' birthweight, gestational age, and growth percentiles, along with mothers' insulin sensitivity and dietary intake. The study begins early in pregnancy and follows participants through at least 6 months postpartum to monitor health outcomes and metabolic changes.
CONDITIONS
Brief Title
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women at 16 weeks gestation or less
- Singleton pregnancy
- Frequent consumption of non-nutritive sweetener beverages (7 or more servings per week)
- Age between 18 and 45 years
- Able to read English at a 5th grade level or higher
- Plan to breastfeed for at least the first 6 months after birth
- For infant participation, the mother must be enrolled and provide consent
You will not qualify if you...
- Physical or mental conditions preventing participation
- Use of medications affecting weight, body composition, insulin resistance, or lipids (e.g., metformin, GLP-1 agonists)
- Tobacco or drug use during pregnancy
- Alcohol consumption greater than one drink per week during pregnancy
- Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., Crohn's disease, ulcerative colitis, inflammatory bowel disease)
- Known or suspected genetic fetal abnormalities or congenital birth defects
- History of gastric bypass surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From early pregnancy through 6 months postpartum
Participants receive interventions to reduce non-nutritive sweetener (NNS) consumption during pregnancy and/or lactation or receive counseling on home safety and babyproofing, depending on their group assignment.
Bi-weekly shipments of unsweetened beverages and weekly automated text messages for intervention groups; weekly automated text messages for control group
Trial Site Locations
Total: 1 location
1
The George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
A
Allison C Sylvetsky, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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