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Pregnancy Exercise Mode Effect on Childhood Obesity

Primary Purpose

Pregnancy, Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Modes
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring exercise modes, exercise intervention

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18 to 40 years old
  • BMI between ≥ 25
  • 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

Sites / Locations

  • East Carolina UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Aerobic Exercise (AE)

Resistance Exercise (RE)

Combination Exercise (AERE)

Control (no exercise)

Arm Description

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.

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).

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.

The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Outcomes

Primary Outcome Measures

1 month Infant non-HDL
non-HDL measured from venipuncture
6 month Infant non-HDL
non-HDL measured from venipuncture
12 month Infant non-HDL
non-HDL measured from venipuncture
1 month Infant BMI z-score
BMI normalized
6 month Infant BMI z-score
BMI normalized
12 month Infant BMI z-score
BMI normalized
Enrollment (8-13wks) Maternal fasting non-HDL
non-HDL measured from venipuncture
36wk Maternal fasting non-HDL
non-HDL measured from venipuncture
1 month postpartum Maternal fasting non-HDL
non-HDL measured from venipuncture
6 months postpartum Maternal fasting non-HDL
non-HDL measured from venipuncture
Adverse Pregnancy Outcomes
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2021
Last Updated
August 5, 2023
Sponsor
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT04805502
Brief Title
Pregnancy Exercise Mode Effect on Childhood Obesity
Official Title
Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
January 30, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of this proposal is to conduct a longitudinal prospective study of overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims: Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB 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 [HR], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB 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 OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB 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 study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.
Detailed Description
Many public health initiatives in the United States, including Healthy People 2020, have goals that include reducing obesity (OB), metabolic dysfunction, and risk of cardiovascular disease (CVD). Studies such as the Bogalusa project have now demonstrated that overweightness (OW), beginning as early as age five, is predictive of adult CVD. In fact, the onset of OW/OB and CVD may begin in the intrauterine period, and infant birth weight and weight gain are strongly related to OB in childhood and beyond. OW/OB mothers and their offspring exhibit increased morbidity and mortality; the American College of Obstetricians and Gynecologists (ACOG) has developed guidelines geared toward reducing maternal OW/OB through exercise. However, few studies have focused on how such exercise interventions during pregnancy impact short and long-term child health outcomes. Furthermore, little is known regarding the influence of different modes of antenatal exercise upon maternal and offspring health outcomes. The long-term goal of this study is to attenuate child- and adulthood OB and CVD risk by identifying the most effective and easily implemented maternal exercise interventions. The investigators have shown that maternal aerobic exercise (AE) in women of all BMIs favorably impacts maternal cholesterol and LDL levels, which are predictive of infant weight. Furthermore, maternal AE is associated with decreased fetal abdominal circumference (AC), lower body fat percentage at one month, and improved infant neuromotor skills. Our preliminary data for pregnant women of all BMIs suggests that resistance exercise (RE) confers similar benefits to infants at one month as compared to AE, plus improvements such as decreased BMI z-scores, increased metabolomic signatures for glucose use, and decreased metabolites of inflammatory pathways. The most striking finding from this preliminary work is that adding RE to AE improved outcomes for both mothers and infants. Thus, the COMBINATION of aerobic and resistance exercise (AERE) not only had better maternal and one month infant outcomes (versus AE alone), but AERE groups had the best compliance. The positive changes were most pronounced in the infants of OW/OB women. A more comprehensive, longitudinal study geared toward OW/OB mothers is needed to confirm our preliminary work and to assess the persistence of exercise impacts through the infants' first year of life. The overall objective of this proposal is to conduct a longitudinal prospective study of OW/OB 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 284 OW/OB pregnant women randomized to an exercise intervention (AE, RE, AERE) 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 AERE and RE exercise training during pregnancy will, in OW/OB women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. The investigators will test this hypothesis with two specific aims: Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased BMI z-score, body fat %, non-HDL, heart rate, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB 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 OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, body fat %, HR, non-HDL, weight gain) across pregnancy (~13 to ~40 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB 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 with improved health outcomes. 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 are at increased risk due to maternal OW/OB. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Overweight and Obesity
Keywords
exercise modes, exercise intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
those performing measurements on participants will be blinded to group allocation.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise (AE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Resistance Exercise (RE)
Arm Type
Experimental
Arm Description
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).
Arm Title
Combination Exercise (AERE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (no exercise)
Arm Type
No Intervention
Arm Description
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Modes
Intervention Description
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
Primary Outcome Measure Information:
Title
1 month Infant non-HDL
Description
non-HDL measured from venipuncture
Time Frame
1 month
Title
6 month Infant non-HDL
Description
non-HDL measured from venipuncture
Time Frame
6 months
Title
12 month Infant non-HDL
Description
non-HDL measured from venipuncture
Time Frame
12 months
Title
1 month Infant BMI z-score
Description
BMI normalized
Time Frame
1 month
Title
6 month Infant BMI z-score
Description
BMI normalized
Time Frame
6 months
Title
12 month Infant BMI z-score
Description
BMI normalized
Time Frame
12 months
Title
Enrollment (8-13wks) Maternal fasting non-HDL
Description
non-HDL measured from venipuncture
Time Frame
enrollment (~8-13 wks gestation)
Title
36wk Maternal fasting non-HDL
Description
non-HDL measured from venipuncture
Time Frame
36 weeks gestation
Title
1 month postpartum Maternal fasting non-HDL
Description
non-HDL measured from venipuncture
Time Frame
1 month postpartum
Title
6 months postpartum Maternal fasting non-HDL
Description
non-HDL measured from venipuncture
Time Frame
6 months postpartum
Title
Adverse Pregnancy Outcomes
Description
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)
Time Frame
At Delivery
Secondary Outcome Measure Information:
Title
1 month Infant Resting Heart Rate
Description
resting HR
Time Frame
1 month
Title
6 month Infant Resting Heart Rate
Description
resting HR
Time Frame
6 months
Title
12 month Infant Resting Heart Rate
Description
resting HR
Time Frame
12 months
Title
1 month Infant Resting Blood Pressure
Description
resting BP
Time Frame
1 month
Title
6 month Infant Resting Blood Pressure
Description
resting BP
Time Frame
6 months
Title
12 month Infant Resting Blood Pressure
Description
resting BP
Time Frame
12 months
Title
1 month Infant Body Fat %
Description
estimated body fat % from skinfolds
Time Frame
1 month
Title
6 month Infant Body Fat %
Description
estimated body fat % from skinfolds
Time Frame
6 months
Title
12 month Infant Body Fat %
Description
estimated body fat % from skinfolds
Time Frame
12 months
Title
1 month Infant % Muscle Mass
Description
estimated muscle mass % from skinfolds
Time Frame
1 months
Title
6 month Infant % Muscle Mass
Description
estimated muscle mass % from skinfolds
Time Frame
6 months
Title
12 month Infant % Muscle Mass
Description
estimated muscle mass % from skinfolds
Time Frame
12 months
Title
1 month Infant Resting Energy Expenditure (REE)
Description
estimated REE
Time Frame
1 months
Title
6 month Infant Resting Energy Expenditure (REE)
Description
estimated resting energy expenditure
Time Frame
6 months
Title
12 month Infant Resting Energy Expenditure (REE)
Description
estimated resting energy expenditure
Time Frame
12 months
Title
1 month Infant Neuromotor Assessment
Description
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time Frame
1 months
Title
6 month Infant Neuromotor Assessment
Description
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time Frame
6 months
Title
12 month Infant Neuromotor Assessment
Description
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Time Frame
12 months
Title
1 month Infant Veggie Meter
Description
Raman Spectroscopy-Skin Carotenoid assessments
Time Frame
1 month
Title
6 month Infant Veggie Meter
Description
Raman spectroscopy-Skin Carotenoid assessments
Time Frame
6 months
Title
12 month Infant Veggie Meter
Description
Raman spectroscopy-Skin Carotenoid assessments
Time Frame
12 months
Title
1 month Infant Blood Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
1 month
Title
6 month Infant Blood Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
6 months
Title
12 month Infant Blood Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
12 months
Title
1 month Infant Blood Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
1 month
Title
6 month Infant Blood Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
6 months
Title
12 month Infant Blood Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
12 months
Title
1 month Infant Blood Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
1 month
Title
6 month Infant Blood Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
6 month
Title
12 month Infant Blood Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
12 months
Title
1 month Infant Metabolomics
Description
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time Frame
1 month
Title
6 month Infant Metabolomics
Description
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time Frame
6 months
Title
12 months Infant Metabolomics
Description
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Time Frame
12 months
Title
16wk Maternal Resting Heart Rate
Description
resting HR
Time Frame
16 gestation
Title
36wk Maternal Resting Heart Rate
Description
resting HR
Time Frame
36 weeks gestation
Title
1 month postpartum Maternal Resting Heart Rate
Description
resting HR
Time Frame
1 month postpartum
Title
6 month postpartum Maternal Resting Heart Rate
Description
resting HR
Time Frame
6 months postpartum
Title
16wk Maternal Resting Blood Pressure
Description
resting BP
Time Frame
16 weeks gestation
Title
36wk Maternal Resting Blood Pressure
Description
resting BP
Time Frame
36 weeks gestation
Title
1 month postpartum Maternal Resting Blood Pressure
Description
resting BP
Time Frame
1 month postpartum
Title
6 month postpartum Maternal Resting Blood Pressure
Description
resting BP
Time Frame
6 months postpartum
Title
Maternal Gestational Weight Gain (GWG)
Description
Gestational Weight Gain
Time Frame
at delivery
Title
16wk Maternal Body Fat%
Description
Estimated body fat %
Time Frame
16 weeks gestation
Title
36wk Maternal Body Fat%
Description
Estimated body fat %
Time Frame
36 weeks gestation
Title
1 month Postpartum Maternal Body Fat%
Description
Estimated body fat %
Time Frame
1 month postpartum
Title
6 month Postpartum Maternal Body Fat%
Description
Estimated body fat %
Time Frame
6 months postpartum
Title
16wk Maternal Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
16 weeks gestation
Title
36wk Maternal Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
36 weeks gestation
Title
1 month postpartum Maternal Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
1 month postpartum
Title
6 month Postpartum Maternal Biomarkers (CRP)
Description
Multiplex analyses of inflammatory markers (CRP)
Time Frame
6 months postpartum
Title
16wk Maternal Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
16 weeks gestation
Title
36wk Maternal Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
36 weeks gestation
Title
1 month Postpartum Maternal Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
1 month postpartum
Title
6 month Postpartum Maternal Biomarkers (IL6)
Description
Multiplex analyses of inflammatory markers (IL6)
Time Frame
6 months postpartum
Title
16wk Maternal Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
16 weeks gestation
Title
36wk Maternal Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
36 weeks gestation
Title
1 month Postpartum Maternal Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
1 month postpartum
Title
6 month Postpartum Maternal Biomarkers (adiponectin)
Description
Multiplex analyses of inflammatory markers (adiponectin)
Time Frame
6 months postpartum
Title
16wk Maternal Biomarkers (cortisol)
Description
Multiplex analyses of inflammatory markers (cortisol)
Time Frame
16 weeks gestation
Title
36wk Maternal Biomarkers (cortisol)
Description
Multiplex analyses of inflammatory markers (cortisol)
Time Frame
36 weeks gestation
Title
1 month Postpartum Maternal Biomarkers (cortisol)
Description
Multiplex analyses of inflammatory markers (cortisol)
Time Frame
1 month postpartum
Title
6 month Postpartum Maternal Biomarkers (cortisol)
Description
Multiplex analyses of inflammatory markers (cortisol)
Time Frame
6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18 to 40 years old BMI between ≥ 25 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda E May, MS, PhD
Phone
2527377072
Email
mayl@ecu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jameta Edwards
Phone
2527377156
Email
edwardsja@ecu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda E May, PhD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda E May, MS, PhD
Phone
252-737-7072
Email
mayl@ecu.edu
First Name & Middle Initial & Last Name & Degree
James DeVente, MD
Email
deventeja@ecu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
de-identified data can be shared upon request to researchers

Learn more about this trial

Pregnancy Exercise Mode Effect on Childhood Obesity

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