Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598098
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
MAMA Tot - Healthy Weight Parallel Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MAMA Tot - Healthy Weight Parallel Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 healthy 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 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 eg 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 eg decreased BMI z-score non-HDL body fat HR weight gain across pregnancy 16 to 36 weeks gestation and overall pregnancy outcomes eg 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
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 eg 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 eg decreased BMI z-score non-HDL body fat HR weight gain across pregnancy 16 to 36 weeks gestation and overall pregnancy outcomes eg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None