RECRUITING

MAMA Tot - Healthy Weight Parallel Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MAMA Tot - Healthy Weight Parallel Study

Quick Facts

Study Start:2021-10-18
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06598098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18 to 40 years old
  2. * BMI 18.5 to 24.4
  3. * Pregnancy: Singleton; ≤ 16 weeks gestation
  4. * Clearance by Obstetric provider for exercise
  1. * Age: ≤ 17.9 or ≥ 41 years of age
  2. * BMI ≥25
  3. * Multi fetal pregnancy
  4. * Obstetric Provider does not provide clearance for exercise
  5. * Unable or Unwilling to provide consent
  6. * Inability to communicate with members of study team, despite use of interpreter
  7. * Medical Conditions (e,g. HIV/Aids, Cancer, Type 1 or 2 Diabetes, Untreated Hypertension, Thyroid Disorders)
  8. * Use of tobacco products, alcohol, recreational drugs, or medications (oral hypertensive, insulin)
  9. * Unable to provide phone or email contact

Contacts and Locations

Study Contact

Linda E May, MS, PhD
CONTACT
252-737-7072
mayl@ecu.edu
Jameta Edwards
CONTACT
252-737-7156
edwardsja@ecu.edu

Principal Investigator

Linda May, MS, PhD
PRINCIPAL_INVESTIGATOR
East Carolina University

Study Locations (Sites)

East Carolina University
Greenville, North Carolina, 27834
United States

Collaborators and Investigators

Sponsor: East Carolina University

  • Linda May, MS, PhD, PRINCIPAL_INVESTIGATOR, East Carolina University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-18
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2021-10-18
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • exercise modes
  • exercise intervention

Additional Relevant MeSH Terms

  • Pregnancy Related