MAMA Tot - Healthy Weight Parallel Study

Overview

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 gestation) compared to HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance. The proposed innovative study will be the first to provide a critical understanding of the influence of antenatal exercise modes upon the cardiometabolic health and growth trajectories of offspring who may be at increased risk of poor outcomes. This work will have a significant impact on reducing the cycle of OB and CVD, potentially providing the earliest and most efficacious intervention to attenuate or prevent OB and CVD in the next generation.

Interventions

• Behavioral Exercise Modes
  Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

Primary outcome measures

• 1 month Infant non-HDL [Time frame: 1 month]
• 6 month Infant non-HDL [Time frame: 6 months]
• 12 month Infant non-HDL [Time frame: 12 months]
• 1 month infant BMI z-score [Time frame: 1 month]
• 6 month infant BMI z-score [Time frame: 6 months]
• 12 month infant BMI z-score [Time frame: 12 months]
• Enrollment (8-13wks) Maternal fasting non-HDL [Time frame: enrollment (~8-13 wks gestation)]
• 36wk Maternal fasting non-HDL [Time frame: 36wks gestation]
• 1 month Maternal fasting non-HDL [Time frame: 1 month postpartum]
• 6 month Maternal fasting non-HDL [Time frame: 6 months postpartum]

Secondary outcome measures (12)

• 1 month infant Resting Heart Rate [Time frame: 1 month]
• 6 month infant Resting Heart Rate [Time frame: 6 months]
• 12 month infant Resting Heart Rate [Time frame: 12 months]
• 1 month infant Resting Blood Pressure [Time frame: 1 month]
• 6 month infant Resting Blood Pressure [Time frame: 6 months]
• 12 month infant Resting Blood Pressure [Time frame: 12 months]
• 1 month infant Body Fat % [Time frame: 1 month]
• 6 month infant Body Fat % [Time frame: 6 months]
• 12 month infant Body Fat % [Time frame: 12 months]
• 1 month infant % Muscle Mass [Time frame: 1 month]
• 6 month infant % Muscle Mass [Time frame: 6 months]
• 12 month infant % Muscle Mass [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 1 center

• East Carolina University — Greenville

Identifiers

NCT: NCT06598098 · 20-002367

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗