MAMA Tot - Healthy Weight Parallel Study

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• Age: 18 to 40 years old
• BMI 18.5 to 24.4
• Pregnancy: Singleton; ≤ 16 weeks gestation
• Clearance by Obstetric provider for exercise

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• East Carolina University — Greenville

Идентификаторы

NCT: NCT06598098 · 20-002367

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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