MAMA Tot - Healthy Weight Parallel Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- East Carolina University
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- 1 month Infant non-HDL
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Linda May
Associate Professor; Dept. Chair
East Carolina University
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
- •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
Outcomes
Primary Outcomes
1 month Infant non-HDL
Time Frame: 1 month
non-HDL measures from venipuncture
6 month Infant non-HDL
Time Frame: 6 months
non-HDL measures from venipuncture
12 month Infant non-HDL
Time Frame: 12 months
non-HDL measures from venipuncture
1 month infant BMI z-score
Time Frame: 1 month
BMI normalized
6 month infant BMI z-score
Time Frame: 6 months
BMI normalized
12 month infant BMI z-score
Time Frame: 12 months
BMI normalized
Enrollment (8-13wks) Maternal fasting non-HDL
Time Frame: enrollment (~8-13 wks gestation)
non-HDL measured from venipuncture
36wk Maternal fasting non-HDL
Time Frame: 36wks gestation
non-HDL measured from venipuncture
1 month Maternal fasting non-HDL
Time Frame: 1 month postpartum
non-HDL measured from venipuncture
6 month Maternal fasting non-HDL
Time Frame: 6 months postpartum
non-HDL measured from venipuncture
Adverse Pregnancy Outcomes
Time Frame: At delivery
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)
12 month Maternal fasting non-HDL
Time Frame: 12 months postpartum
non-HDL measured from venipuncture
Secondary Outcomes
- 12 month Postpartum Maternal Resting Blood Pressure(12 months postpartum)
- Maternal Gestational Weight Gain (GWG)(At delivery)
- 16wk Maternal Body Fat %(16wks gestation)
- 1 month infant Resting Heart Rate(1 month)
- 6 month infant Resting Heart Rate(6 months)
- 12 month infant Resting Heart Rate(12 months)
- 1 month infant Resting Blood Pressure(1 month)
- 6 month infant Resting Blood Pressure(6 months)
- 12 month infant Resting Blood Pressure(12 months)
- 1 month infant Body Fat %(1 month)
- 6 month infant Body Fat %(6 months)
- 12 month infant Body Fat %(12 months)
- 1 month infant % Muscle Mass(1 month)
- 6 month infant % Muscle Mass(6 months)
- 12 month infant % Muscle Mass(12 months)
- 1 month Infant Resting Energy Expenditure (REE)(1 month)
- 6 month Infant Resting Energy Expenditure (REE)(6 months)
- 12 month Infant Resting Energy Expenditure (REE)(12 months)
- 1 month Infant Neuromotor Assessment(1 month)
- 6 month Infant Neuromotor Assessment(6 months)
- 12 month Infant Neuromotor Assessment(12 months)
- 1 month Infant Veggie Meter(1 month)
- 6 month Infant Veggie Meter(6 months)
- 12 month Infant Veggie Meter(12 months)
- 1 month Infant Blood Biomarkers (CRP)(1 month)
- 6 month Infant Blood Biomarkers (CRP)(6 months)
- 12 month Infant Blood Biomarkers (CRP)(12 months)
- 1 month Infant Blood Biomarkers (IL6)(1 month)
- 6 month Infant Blood Biomarkers (IL6)(6 months)
- 12 month Infant Blood Biomarkers (IL6)(12 months)
- 1 month Infant Blood Biomarkers (adiponectin)(1 month)
- 6 month Infant Blood Biomarkers (adiponectin)(6 months)
- 12 month Infant Blood Biomarkers (adiponectin)(12 months)
- 1 month Infant Metabolomics(1 month)
- 6 month Infant Metabolomics(6 months)
- 12 month Infant Metabolomics(12 months)
- 16wk Maternal Resting Heart Rate(16wks gestation)
- 36wk Maternal Resting Heart Rate(36wks gestation)
- 1 month Postpartum Maternal Resting Heart Rate(1 month postpartum)
- 6 month Postpartum Maternal Resting Heart Rate(6 months postpartum)
- 12 month Postpartum Maternal Resting Heart Rate(12 months postpartum)
- 16wk Maternal Resting Blood Pressure(16wks gestation)
- 36wk Maternal Resting Blood Pressure(36wks gestation)
- 1 month Postpartum Maternal Resting Blood Pressure(1 month postpartum)
- 6 month Postpartum Maternal Resting Blood Pressure(6 months postpartum)
- 36wk Maternal Body Fat %(36wks gestation)
- 1 month Postpartum Maternal Body Fat %(1 month postpartum)
- 6 month Postpartum Maternal Body Fat %(6 months postpartum)
- 12 month Postpartum Maternal Body Fat %(12 months postpartum)
- 16wk Maternal Biomarkers (CRP)(16wks gestation)
- 36wk Maternal Biomarkers (CRP)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (CRP)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (CRP)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (CRP)(12 months postpartum)
- 16wk Maternal Biomarkers (IL6)(16wks gestation)
- 36wk Maternal Biomarkers (IL6)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (IL6)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (IL6)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (IL6)(12 months postpartum)
- 16wks Maternal Biomarkers (adiponectin)(16wks gestation)
- 36wks Maternal Biomarkers (adiponectin)(36wks gestation)
- 1 month postpartum Maternal Biomarkers (adiponectin)(1 month postpartum)
- 6 month postpartum Maternal Biomarkers (adiponectin)(6 months postpartum)
- 12 month postpartum Maternal Biomarkers (adiponectin)(12 months postpartum)
- 16wks Maternal Biomarkers (cortisol)(16wks gestation)
- 36wks Maternal Biomarkers (cortisol)(36wks gestation)
- 1 month Postpartum Maternal Biomarkers (cortisol)(1 month postpartum)
- 6 month Postpartum Maternal Biomarkers (cortisol)(6 months postpartum)
- 12 month Postpartum Maternal Biomarkers (cortisol)(12 months postpartum)