MAMA Tot - Healthy Weight Parallel Study
- Conditions
- Pregnancy Related
- Interventions
- Behavioral: Exercise Modes
- Registration Number
- NCT06598098
- Lead Sponsor
- East Carolina University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 268
- Age: 18 to 40 years old
- BMI 18.5 to 24.4
- Pregnancy: Singleton; ≤ 16 weeks gestation
- Clearance by Obstetric provider for exercise
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic Exercise (AE) Exercise Modes 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions. Resistance Exercise (RE) Exercise Modes 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.\[100\] Seated isokinetic exercise using Cybex machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends). Combination Exercise (AERE) Exercise Modes 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. The AERE group will switch between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeated repeat with different exercises.\[106-108\] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups.
- Primary Outcome Measures
Name Time Method 1 month Infant non-HDL 1 month non-HDL measures from venipuncture
6 month Infant non-HDL 6 months non-HDL measures from venipuncture
12 month Infant non-HDL 12 months non-HDL measures from venipuncture
1 month infant BMI z-score 1 month BMI normalized
6 month infant BMI z-score 6 months BMI normalized
12 month infant BMI z-score 12 months BMI normalized
Enrollment (8-13wks) Maternal fasting non-HDL enrollment (~8-13 wks gestation) non-HDL measured from venipuncture
36wk Maternal fasting non-HDL 36wks gestation non-HDL measured from venipuncture
1 month Maternal fasting non-HDL 1 month postpartum non-HDL measured from venipuncture
6 month Maternal fasting non-HDL 6 months postpartum non-HDL measured from venipuncture
Adverse Pregnancy Outcomes At delivery Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)
12 month Maternal fasting non-HDL 12 months postpartum non-HDL measured from venipuncture
- Secondary Outcome Measures
Name Time Method 1 month infant Resting Heart Rate 1 month resting HR
6 month infant Resting Heart Rate 6 months resting HR
12 month infant Resting Heart Rate 12 months resting HR
1 month infant Resting Blood Pressure 1 month resting BP
6 month infant Resting Blood Pressure 6 months resting BP
12 month infant Resting Blood Pressure 12 months resting BP
1 month infant Body Fat % 1 month body fat % from skinfolds
6 month infant Body Fat % 6 months body fat % from skinfolds
12 month infant Body Fat % 12 months body fat % from skinfolds
1 month infant % Muscle Mass 1 month muscle mass % from skinfolds
6 month infant % Muscle Mass 6 months muscle mass % from skinfolds
12 month infant % Muscle Mass 12 months muscle mass % from skinfolds
1 month Infant Resting Energy Expenditure (REE) 1 month resting REE
6 month Infant Resting Energy Expenditure (REE) 6 months resting REE
12 month Infant Resting Energy Expenditure (REE) 12 months resting REE
1 month Infant Neuromotor Assessment 1 month Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
6 month Infant Neuromotor Assessment 6 months Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
12 month Infant Neuromotor Assessment 12 months Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
1 month Infant Veggie Meter 1 month Raman Spectroscopy-Skin Carotenoid assessments
6 month Infant Veggie Meter 6 months Raman Spectroscopy-Skin Carotenoid assessments
12 month Infant Veggie Meter 12 months Raman Spectroscopy-Skin Carotenoid assessments
1 month Infant Blood Biomarkers (CRP) 1 month Multiplex analyses of inflammatory markers (CRP)
6 month Infant Blood Biomarkers (CRP) 6 months Multiplex analyses of inflammatory markers (CRP)
12 month Infant Blood Biomarkers (CRP) 12 months Multiplex analyses of inflammatory markers (CRP)
1 month Infant Blood Biomarkers (IL6) 1 month Multiplex analyses of inflammatory markers (IL6)
6 month Infant Blood Biomarkers (IL6) 6 months Multiplex analyses of inflammatory markers (IL6)
12 month Infant Blood Biomarkers (IL6) 12 months Multiplex analyses of inflammatory markers (IL6)
1 month Infant Blood Biomarkers (adiponectin) 1 month Multiplex analyses of inflammatory markers (adiponectin)
6 month Infant Blood Biomarkers (adiponectin) 6 months Multiplex analyses of inflammatory markers (adiponectin)
12 month Infant Blood Biomarkers (adiponectin) 12 months Multiplex analyses of inflammatory markers (adiponectin)
1 month Infant Metabolomics 1 month Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
6 month Infant Metabolomics 6 months Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
12 month Infant Metabolomics 12 months Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
16wk Maternal Resting Heart Rate 16wks gestation resting HR
36wk Maternal Resting Heart Rate 36wks gestation resting HR
1 month Postpartum Maternal Resting Heart Rate 1 month postpartum resting HR
6 month Postpartum Maternal Resting Heart Rate 6 months postpartum resting HR
12 month Postpartum Maternal Resting Heart Rate 12 months postpartum resting HR
16wk Maternal Resting Blood Pressure 16wks gestation resting BP
36wk Maternal Resting Blood Pressure 36wks gestation resting BP
1 month Postpartum Maternal Resting Blood Pressure 1 month postpartum resting BP
6 month Postpartum Maternal Resting Blood Pressure 6 months postpartum resting BP
12 month Postpartum Maternal Resting Blood Pressure 12 months postpartum resting BP
Maternal Gestational Weight Gain (GWG) At delivery Gestational Weight Gain
16wk Maternal Body Fat % 16wks gestation estimated body fat %
36wk Maternal Body Fat % 36wks gestation estimated body fat %
1 month Postpartum Maternal Body Fat % 1 month postpartum estimated body fat %
6 month Postpartum Maternal Body Fat % 6 months postpartum estimated body fat %
12 month Postpartum Maternal Body Fat % 12 months postpartum estimated body fat %
16wk Maternal Biomarkers (CRP) 16wks gestation Multiplex analyses of inflammatory markers (CRP)
36wk Maternal Biomarkers (CRP) 36wks gestation Multiplex analyses of inflammatory markers (CRP)
1 month Postpartum Maternal Biomarkers (CRP) 1 month postpartum Multiplex analyses of inflammatory markers (CRP)
6 month Postpartum Maternal Biomarkers (CRP) 6 months postpartum Multiplex analyses of inflammatory markers (CRP)
12 month Postpartum Maternal Biomarkers (CRP) 12 months postpartum Multiplex analyses of inflammatory markers (CRP)
16wk Maternal Biomarkers (IL6) 16wks gestation Multiplex analyses of inflammatory markers (IL6)
36wk Maternal Biomarkers (IL6) 36wks gestation Multiplex analyses of inflammatory markers (IL6)
1 month Postpartum Maternal Biomarkers (IL6) 1 month postpartum Multiplex analyses of inflammatory markers (IL6)
6 month Postpartum Maternal Biomarkers (IL6) 6 months postpartum Multiplex analyses of inflammatory markers (IL6)
12 month Postpartum Maternal Biomarkers (IL6) 12 months postpartum Multiplex analyses of inflammatory markers (IL6)
16wks Maternal Biomarkers (adiponectin) 16wks gestation Multiplex analyses of inflammatory markers (adiponectin)
36wks Maternal Biomarkers (adiponectin) 36wks gestation Multiplex analyses of inflammatory markers (adiponectin)
1 month postpartum Maternal Biomarkers (adiponectin) 1 month postpartum Multiplex analyses of inflammatory markers (adiponectin)
6 month postpartum Maternal Biomarkers (adiponectin) 6 months postpartum Multiplex analyses of inflammatory markers (adiponectin)
12 month postpartum Maternal Biomarkers (adiponectin) 12 months postpartum Multiplex analyses of inflammatory markers (adiponectin)
16wks Maternal Biomarkers (cortisol) 16wks gestation Multiplex analyses of inflammatory markers (cortisol)
36wks Maternal Biomarkers (cortisol) 36wks gestation Multiplex analyses of inflammatory markers (cortisol)
1 month Postpartum Maternal Biomarkers (cortisol) 1 month postpartum Multiplex analyses of inflammatory markers (cortisol)
6 month Postpartum Maternal Biomarkers (cortisol) 6 months postpartum Multiplex analyses of inflammatory markers (cortisol)
12 month Postpartum Maternal Biomarkers (cortisol) 12 months postpartum Multiplex analyses of inflammatory markers (cortisol)
Trial Locations
- Locations (1)
East Carolina University
🇺🇸Greenville, North Carolina, United States