Clinical trial NCT06598098: MAMA Tot - Healthy Weight Parallel Study
Official title: MAMA Tot - Healthy Weight Parallel Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: exercise modes
exercise intervention
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, rating of perceived exertion (RPE), 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Primary purpose: PREVENTION

Brief 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 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.


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

Primary outcomes:
measure: 1 month Infant non-HDL
timeFrame: 1 month
measure: 6 month Infant non-HDL
timeFrame: 6 months
measure: 12 month Infant non-HDL
timeFrame: 12 months
measure: 1 month infant BMI z-score
timeFrame: 1 month
measure: 6 month infant BMI z-score
timeFrame: 6 months
measure: 12 month infant BMI z-score
timeFrame: 12 months
measure: Enrollment (8-13wks) Maternal fasting non-HDL
timeFrame: enrollment (~8-13 wks gestation)
measure: 36wk Maternal fasting non-HDL
timeFrame: 36wks gestation
measure: 1 month Maternal fasting non-HDL
timeFrame: 1 month postpartum
measure: 6 month Maternal fasting non-HDL
timeFrame: 6 months postpartum
measure: Adverse Pregnancy Outcomes
timeFrame: At delivery
measure: 12 month Maternal fasting non-HDL
timeFrame: 12 months postpartum
Secondary outcomes:
measure: 1 month infant Resting Heart Rate
timeFrame: 1 month
measure: 6 month infant Resting Heart Rate
timeFrame: 6 months
measure: 12 month infant Resting Heart Rate
timeFrame: 12 months
measure: 1 month infant Resting Blood Pressure
timeFrame: 1 month
measure: 6 month infant Resting Blood Pressure
timeFrame: 6 months
measure: 12 month infant Resting Blood Pressure
timeFrame: 12 months
measure: 1 month infant Body Fat %
timeFrame: 1 month
measure: 6 month infant Body Fat %
timeFrame: 6 months
measure: 12 month infant Body Fat %
timeFrame: 12 months
measure: 1 month infant % Muscle Mass
timeFrame: 1 month
measure: 6 month infant % Muscle Mass
timeFrame: 6 months
measure: 12 month infant % Muscle Mass
timeFrame: 12 months
measure: 1 month Infant Resting Energy Expenditure (REE)
timeFrame: 1 month
measure: 6 month Infant Resting Energy Expenditure (REE)
timeFrame: 6 months
measure: 12 month Infant Resting Energy Expenditure (REE)
timeFrame: 12 months
measure: 1 month Infant Neuromotor Assessment
timeFrame: 1 month
measure: 6 month Infant Neuromotor Assessment
timeFrame: 6 months
measure: 12 month Infant Neuromotor Assessment
timeFrame: 12 months
measure: 1 month Infant Veggie Meter
timeFrame: 1 month
measure: 6 month Infant Veggie Meter
timeFrame: 6 months
measure: 12 month Infant Veggie Meter
timeFrame: 12 months
measure: 1 month Infant Blood Biomarkers (CRP)
timeFrame: 1 month
measure: 6 month Infant Blood Biomarkers (CRP)
timeFrame: 6 months
measure: 12 month Infant Blood Biomarkers (CRP)
timeFrame: 12 months
measure: 1 month Infant Blood Biomarkers (IL6)
timeFrame: 1 month
measure: 6 month Infant Blood Biomarkers (IL6)
timeFrame: 6 months
measure: 12 month Infant Blood Biomarkers (IL6)
timeFrame: 12 months
measure: 1 month Infant Blood Biomarkers (adiponectin)
timeFrame: 1 month
measure: 6 month Infant Blood Biomarkers (adiponectin)
timeFrame: 6 months
measure: 12 month Infant Blood Biomarkers (adiponectin)
timeFrame: 12 months
measure: 1 month Infant Metabolomics
timeFrame: 1 month
measure: 6 month Infant Metabolomics
timeFrame: 6 months
measure: 12 month Infant Metabolomics
timeFrame: 12 months
measure: 16wk Maternal Resting Heart Rate
timeFrame: 16wks gestation
measure: 36wk Maternal Resting Heart Rate
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Resting Heart Rate
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Resting Heart Rate
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Resting Heart Rate
timeFrame: 12 months postpartum
measure: 16wk Maternal Resting Blood Pressure
timeFrame: 16wks gestation
measure: 36wk Maternal Resting Blood Pressure
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Resting Blood Pressure
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Resting Blood Pressure
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Resting Blood Pressure
timeFrame: 12 months postpartum
measure: Maternal Gestational Weight Gain (GWG)
timeFrame: At delivery
measure: 16wk Maternal Body Fat %
timeFrame: 16wks gestation
measure: 36wk Maternal Body Fat %
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Body Fat %
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Body Fat %
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Body Fat %
timeFrame: 12 months postpartum
measure: 16wk Maternal Biomarkers (CRP)
timeFrame: 16wks gestation
measure: 36wk Maternal Biomarkers (CRP)
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Biomarkers (CRP)
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Biomarkers (CRP)
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Biomarkers (CRP)
timeFrame: 12 months postpartum
measure: 16wk Maternal Biomarkers (IL6)
timeFrame: 16wks gestation
measure: 36wk Maternal Biomarkers (IL6)
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Biomarkers (IL6)
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Biomarkers (IL6)
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Biomarkers (IL6)
timeFrame: 12 months postpartum
measure: 16wks Maternal Biomarkers (adiponectin)
timeFrame: 16wks gestation
measure: 36wks Maternal Biomarkers (adiponectin)
timeFrame: 36wks gestation
measure: 1 month postpartum Maternal Biomarkers (adiponectin)
timeFrame: 1 month postpartum
measure: 6 month postpartum Maternal Biomarkers (adiponectin)
timeFrame: 6 months postpartum
measure: 12 month postpartum Maternal Biomarkers (adiponectin)
timeFrame: 12 months postpartum
measure: 16wks Maternal Biomarkers (cortisol)
timeFrame: 16wks gestation
measure: 36wks Maternal Biomarkers (cortisol)
timeFrame: 36wks gestation
measure: 1 month Postpartum Maternal Biomarkers (cortisol)
timeFrame: 1 month postpartum
measure: 6 month Postpartum Maternal Biomarkers (cortisol)
timeFrame: 6 months postpartum
measure: 12 month Postpartum Maternal Biomarkers (cortisol)
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Linda May, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: