Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04805502
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2021-03-03
Brief Title:
Pregnancy Exercise Mode Effect on Childhood Obesity
Sponsor:
East Carolina University
Organization:
East Carolina University
Study Overview
Official Title:
Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of this proposal is to conduct a longitudinal prospective study of overweightobese OWOB 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 OWOB pregnant women randomized to an exercise intervention aerobic AE resistance RE or aerobicresistance 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 OWOB pregnancy on infant cardiometabolic health and growth trajectories Hypothesis AE RE and AERE by OWOB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1 6 and 12 months postpartum eg decreased body fat BMI z-score heart rate HR non-HDL and C-Reactive Protein CRP increased insulin sensitivity compared to infants of OWOB 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 OWOB pregnancy on improving maternal cardiometabolic health outcomes Hypothesis AE RE and AERE by OWOB pregnant women will improve both maternal cardiometabolic health measures eg decreased BMI z-score non-HDL body fat HR weight gain across pregnancy 16-36 weeks gestation and overall pregnancy outcomes eg lower incidence of gestational diabetes pre-eclampsia hypertension during gestation compared to OWOB 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 OWOB 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
Aim 1 Determine the influence of different exercise modes during OWOB pregnancy on infant cardiometabolic health and growth trajectories Hypothesis AE RE and AERE by OWOB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1 6 and 12 months postpartum eg decreased body fat BMI z-score heart rate HR non-HDL and C-Reactive Protein CRP increased insulin sensitivity compared to infants of OWOB 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 OWOB pregnancy on improving maternal cardiometabolic health outcomes Hypothesis AE RE and AERE by OWOB pregnant women will improve both maternal cardiometabolic health measures eg decreased BMI z-score non-HDL body fat HR weight gain across pregnancy 16-36 weeks gestation and overall pregnancy outcomes eg lower incidence of gestational diabetes pre-eclampsia hypertension during gestation compared to OWOB 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 OWOB 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 OWOB and CVD may begin in the intrauterine period and infant birth weight and weight gain are strongly related to OB in childhood and beyond OWOB mothers and their offspring exhibit increased morbidity and mortality the American College of Obstetricians and Gynecologists ACOG has developed guidelines geared toward reducing maternal OWOB 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 OWOB women A more comprehensive longitudinal study geared toward OWOB 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 OWOB pregnant women and their offspring to determine which antenatal maternal exercise modes 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 OWOB 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 OWOB 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 OWOB pregnancy on infant cardiometabolic health and growth trajectories Hypothesis AE RE and AERE by OWOB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1 6 and 12 months postpartum eg decreased BMI z-score body fat non-HDL heart rate and C-Reactive Protein CRP increased insulin sensitivity compared to infants of OWOB 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 OWOB pregnancy on improving maternal cardiometabolic health outcomes Hypothesis AE RE and AERE by OWOB pregnant women will improve both maternal cardiometabolic health measures eg decreased BMI z-score body fat HR non-HDL weight gain across pregnancy 13 to 40 weeks gestation and overall pregnancy outcomes eg lower incidence of gestational diabetes pre-eclampsia hypertension during gestation compared to OWOB 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 OWOB 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
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 OWOB women A more comprehensive longitudinal study geared toward OWOB 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 OWOB pregnant women and their offspring to determine which antenatal maternal exercise modes 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 OWOB 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 OWOB 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 OWOB pregnancy on infant cardiometabolic health and growth trajectories Hypothesis AE RE and AERE by OWOB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1 6 and 12 months postpartum eg decreased BMI z-score body fat non-HDL heart rate and C-Reactive Protein CRP increased insulin sensitivity compared to infants of OWOB 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 OWOB pregnancy on improving maternal cardiometabolic health outcomes Hypothesis AE RE and AERE by OWOB pregnant women will improve both maternal cardiometabolic health measures eg decreased BMI z-score body fat HR non-HDL weight gain across pregnancy 13 to 40 weeks gestation and overall pregnancy outcomes eg lower incidence of gestational diabetes pre-eclampsia hypertension during gestation compared to OWOB 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 OWOB 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None