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Prenatal Exercise for Childhood Obesity

N/A

Recruiting

Led By Linda E May, PhD

Research Sponsored by East Carolina University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18 to 40 years old

Be between 18 and 65 years old

Must not have

Use of tobacco products, alcohol, recreational drugs, or medications (oral hypertensive, insulin)

Inability to communicate with members of study team, despite use of interpreter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of different exercise modes during pregnancy on both the mother's and child's cardiometabolic health.

Who is the study for?

This trial is for overweight or obese pregnant women aged 18-40, with a BMI of 25 or higher and in their first 16 weeks of a single pregnancy. They must have clearance from their obstetric provider to exercise. Excluded are those under 18 or over 40, with medical conditions like HIV/AIDS, diabetes, untreated hypertension, thyroid disorders, or who use tobacco, alcohol, drugs.

What is being tested?

The study is testing the effects of different types of prenatal exercises (aerobic only; resistance only; combined aerobic and resistance) on the health outcomes of both mothers and infants compared to no exercise at all. It aims to see which method best improves heart health measures and reduces obesity risk in babies up to one year old.

What are the potential side effects?

While not explicitly stated for this trial since it involves standard physical activities such as aerobic and resistance training typically considered safe during pregnancy when approved by a healthcare provider, potential side effects could include muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use tobacco, alcohol, recreational drugs, or certain medications.

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I can communicate with the study team, with or without an interpreter.

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I am either younger than 18 or older than 41 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1 month Infant BMI z-score

1 month Infant non-HDL

1 month postpartum Maternal fasting non-HDL

+8 more

Secondary study objectives

1 month Infant % Muscle Mass

1 month Infant Blood Biomarkers (CRP)

1 month Infant Blood Biomarkers (IL6)

+59 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Resistance Exercise (RE)Experimental Treatment1 Intervention

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).

Group II: Combination Exercise (AERE)Experimental Treatment1 Intervention

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.

Group III: Aerobic Exercise (AE)Experimental Treatment1 Intervention

Group IV: Control (no exercise)Active Control1 Intervention

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

0 / 4Eligibility criteria met