MAMA Tot - Healthy Weight Parallel Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Exercise Modes

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda E May, MS, PhD; Phone Number: 252-737-7072; Email: mayl@ecu.edu
• Study Contact Backup: Name: Jameta Edwards; Phone Number: 252-737-7156; Email: edwardsja@ecu.edu

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University
      • Contact: Linda E May, MS, PhD; Phone Number: 252-737-7072; Email: mayl@ecu.edu
      • Contact: James DeVente, MD; Email: deventeja@ecu.edu
      • Contact: Linda E May, MS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (no exercise); The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
Experimental: Aerobic Exercise (AE); 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.	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Experimental: Resistance Exercise (RE); 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).	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Experimental: Combination Exercise (AERE); 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.	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment (8-13wks) Maternal fasting non-HDL	non-HDL measured from venipuncture	enrollment (~8-13 wks gestation)
1 month Infant non-HDL	non-HDL measures from venipuncture	1 month
6 month Infant non-HDL	non-HDL measures from venipuncture	6 months
12 month Infant non-HDL	non-HDL measures from venipuncture	12 months
1 month infant BMI z-score	BMI normalized	1 month
6 month infant BMI z-score	BMI normalized	6 months
12 month infant BMI z-score	BMI normalized	12 months
36wk Maternal fasting non-HDL	non-HDL measured from venipuncture	36wks gestation
1 month Maternal fasting non-HDL	non-HDL measured from venipuncture	1 month postpartum
6 month Maternal fasting non-HDL	non-HDL measured from venipuncture	6 months postpartum
Adverse Pregnancy Outcomes	Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)	At delivery
12 month Maternal fasting non-HDL	non-HDL measured from venipuncture	12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	6 months
12 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	12 months
1 month Infant Veggie Meter	Raman Spectroscopy-Skin Carotenoid assessments	1 month
1 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month
6 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months
12 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	12 months
1 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month
6 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months
12 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	12 months
1 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month
12 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	12 months
1 month Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	1 month
6 month Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	6 months
6 month Postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months postpartum
1 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month postpartum
6 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months postpartum
1 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	1 month postpartum
6 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	6 months postpartum
1 month infant Resting Heart Rate	resting HR	1 month
6 month infant Resting Heart Rate	resting HR	6 months
12 month infant Resting Heart Rate	resting HR	12 months
1 month infant Resting Blood Pressure	resting BP	1 month
6 month infant Resting Blood Pressure	resting BP	6 months
12 month infant Resting Blood Pressure	resting BP	12 months
1 month infant Body Fat %	body fat % from skinfolds	1 month
6 month infant Body Fat %	body fat % from skinfolds	6 months
12 month infant Body Fat %	body fat % from skinfolds	12 months
1 month infant % Muscle Mass	muscle mass % from skinfolds	1 month
6 month infant % Muscle Mass	muscle mass % from skinfolds	6 months
12 month infant % Muscle Mass	muscle mass % from skinfolds	12 months
1 month Infant Resting Energy Expenditure (REE)	resting REE	1 month
6 month Infant Resting Energy Expenditure (REE)	resting REE	6 months
12 month Infant Resting Energy Expenditure (REE)	resting REE	12 months
1 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	1 month
6 month Infant Veggie Meter	Raman Spectroscopy-Skin Carotenoid assessments	6 months
12 month Infant Veggie Meter	Raman Spectroscopy-Skin Carotenoid assessments	12 months
6 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 months
12 month Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	12 months
16wk Maternal Resting Heart Rate	resting HR	16wks gestation
36wk Maternal Resting Heart Rate	resting HR	36wks gestation
1 month Postpartum Maternal Resting Heart Rate	resting HR	1 month postpartum
6 month Postpartum Maternal Resting Heart Rate	resting HR	6 months postpartum
12 month Postpartum Maternal Resting Heart Rate	resting HR	12 months postpartum
16wk Maternal Resting Blood Pressure	resting BP	16wks gestation
36wk Maternal Resting Blood Pressure	resting BP	36wks gestation
1 month Postpartum Maternal Resting Blood Pressure	resting BP	1 month postpartum
6 month Postpartum Maternal Resting Blood Pressure	resting BP	6 months postpartum
12 month Postpartum Maternal Resting Blood Pressure	resting BP	12 months postpartum
Maternal Gestational Weight Gain (GWG)	Gestational Weight Gain	At delivery
16wk Maternal Body Fat %	estimated body fat %	16wks gestation
36wk Maternal Body Fat %	estimated body fat %	36wks gestation
1 month Postpartum Maternal Body Fat %	estimated body fat %	1 month postpartum
6 month Postpartum Maternal Body Fat %	estimated body fat %	6 months postpartum
12 month Postpartum Maternal Body Fat %	estimated body fat %	12 months postpartum
16wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	16wks gestation
36wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	36wks gestation
1 month Postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month postpartum
12 month Postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	12 months postpartum
16wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	16wks gestation
36wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	36wks gestation
12 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	12 months postpartum
16wks Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	16wks gestation
36wks Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	36wks gestation
1 month postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month postpartum
6 month postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 months postpartum
12 month postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	12 months postpartum
16wks Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	16wks gestation
36wks Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	36wks gestation
12 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	12 months postpartum

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Principal Investigator: Linda May, MS, PhD, East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: exercise intervention; exercise modes
• Other Study ID Numbers: 20-002367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: de-identified data can be shared upon request to researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No