MAMA Tot - Healthy Weight Parallel Study

NCT06598098 | Recruiting DMC

• 1 other identifier: 20-002367
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pregnancy Related

Keywords

exercise modes; exercise intervention

Outcome Measures

Primary Outcomes (12)

• 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

• Enrollment (8-13wks) Maternal fasting non-HDL

  non-HDL measured from venipuncture

  enrollment (~8-13 wks gestation)

• 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 Outcomes (69)

• 1 month infant Resting Heart Rate

  1 month

• 6 month infant Resting Heart Rate

  6 months

• 12 month infant Resting Heart Rate

  12 months

• 1 month infant Resting Blood Pressure

  1 month

• 6 month infant Resting Blood Pressure

  6 months

Study Arms (4)

Aerobic Exercise (AE)

EXPERIMENTAL

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

Resistance Exercise (RE)

EXPERIMENTAL

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

Combination Exercise (AERE)

EXPERIMENTAL

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

Control (no exercise)

NO INTERVENTION

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

Interventions

Exercise Modes BEHAVIORAL

Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

Aerobic Exercise (AE); Combination Exercise (AERE); Resistance Exercise (RE)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 40 years old
• BMI 18.5 to 24.4
• Pregnancy: Singleton; ≤ 16 weeks gestation
• Clearance by Obstetric provider for exercise

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Study Officials

• Linda May, MS, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda E May, MS, PhD

CONTACT

252-737-7072; mayl@ecu.edu

Jameta Edwards

CONTACT

252-737-7156; edwardsja@ecu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Dept. Chair

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 18, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)