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NCT06598098 · ClinicalTrials.gov registry record · NA
MAMA Tot - Healthy Weight Parallel Study
A NA study of Pregnancy Related, sponsored by East Carolina University.
- Recruiting
- Registry status
- NA
- Development phase
- 268
- Enrollment target
- 1
- Study location
NCT06598098 is a NA study of Pregnancy Related that is actively recruiting participants, run by East Carolina University. The registered enrollment target is 268 participants, below the 1,960-participant average among 99 other Pregnancy Related trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06598098, a NA study of Pregnancy Related, is actively recruiting participants, sponsored by East Carolina University.
- RECRUITING
- Registry status
- NA
- Development phase
- 268 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall objective of this proposal is to conduct a longitudinal prospective study of healthy pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modified clinical practice recommendations that improve health in childhood and possibly beyond. This randomized controlled trial will recruit 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) or to no exercise (usual care); their infants will be measured at 1, 6, and 12 months of age. This rigorous design will test our central hypothesis that aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. We will test this hypothesis with two specific aims: Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased % body fat, BMI z-score, heart rate, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures. Aim 2. Determine the most effective exercise mode in HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestatio
Conditions Studied
Interventions
- BEHAVIORAL Exercise Modes
Study Locations (1)
North Carolina
- East Carolina University - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2027-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06598098
The ClinicalTrials.gov registry entry for NCT06598098 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,960-participant average among 99 other Pregnancy Related trials with a reported enrollment target (86% lower). The listed sponsor is East Carolina University, which has 58 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which Exercise Modes is the first listed.
NCT06598098 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06598098 about?
NCT06598098 is a clinical study titled "MAMA Tot - Healthy Weight Parallel Study". The overall objective of this proposal is to conduct a longitudinal prospective study of healthy pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modifie...
What is the current status of trial NCT06598098?
This trial is currently recruiting. It is a NA study. The enrollment target is 268 participants. The study started on 2021-10-18. Estimated completion is 2027-08-30.
What conditions does trial NCT06598098 study?
This clinical trial studies the following conditions: Pregnancy Related.
What interventions are being tested in trial NCT06598098?
The interventions under investigation include: Exercise Modes (BEHAVIORAL).
Who is sponsoring clinical trial NCT06598098?
This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06598098 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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