Examining the effects of different exercise modes during pregnancy on maternal and infant health
MAMA Tot - Healthy Weight Parallel Study
This study is testing how different types of exercise during pregnancy can affect the health of both mothers and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT06598098 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the impact of various antenatal exercise modes on the cardiometabolic health of healthy pregnant women and their infants. A total of 268 participants will be randomly assigned to different exercise interventions, including aerobic exercise, resistance exercise, or a combination of both, compared to a control group receiving usual care. The infants' health will be monitored at 1, 6, and 12 months of age to assess the long-term effects of maternal exercise during pregnancy. The goal is to determine which exercise mode is most beneficial for both mothers and their children.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women aged 18 to 40 with a BMI between 18.5 and 24.4, who are less than 16 weeks pregnant and have received clearance for exercise from their obstetric provider.
Not a fit: Patients who are outside the age range, have a higher BMI, are in a multifetal pregnancy, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health recommendations for pregnant women, enhancing both maternal and infant health outcomes.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions during pregnancy, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 to 40 years old * BMI 18.5 to 24.4 * Pregnancy: Singleton; ≤ 16 weeks gestation * Clearance by Obstetric provider for exercise Exclusion Criteria: * Age: ≤ 17.9 or ≥ 41 years of age * BMI ≥25 * Multi fetal pregnancy * Obstetric Provider does not provide clearance for exercise * Unable or Unwilling to provide consent * Inability to communicate with members of study team, despite use of interpreter * Medical Conditions (e,g. HIV/Aids, Cancer, Type 1 or 2 Diabetes, Untreated Hypertension, Thyroid Disorders) * Use of tobacco products, alcohol, recreational drugs, or medications (oral hypertensive, insulin) * Unable to provide phone or email contact
Where this trial is running
Greenville, North Carolina
- East Carolina University — Greenville, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Linda May, MS, PhD — East Carolina University
- Study coordinator: Linda E May, MS, PhD
- Email: mayl@ecu.edu
- Phone: 252-737-7072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.