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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 40 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1 month Infant BMI z-score
1 month Infant non-HDL
1 month postpartum Maternal fasting non-HDL
+8 more
Secondary outcome measures
1 month Infant % Muscle Mass
1 month Infant Blood Biomarkers (CRP)
1 month Infant Blood Biomarkers (IL6)
+59 more

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
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.
Group IV: Control (no exercise)Active Control1 Intervention
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Find a Location

Who is running the clinical trial?

East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,509 Total Patients Enrolled
11 Trials studying Obesity
1,149 Patients Enrolled for Obesity
Linda E May, PhDPrincipal InvestigatorPI

Media Library

Obesity Clinical Trial 2023: Exercise Modes Highlights & Side Effects. Trial Name: NCT04805502 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria for participating in this clinical research?

"This research initiative is hoping to enroll 300 qualifying pediatric obesity patients between the ages of 18 and 40. To be eligible, participants must meet the following criteria: pregnant with one fetus under 16 weeks gestation; aged 18-40 years old; a BMI greater than or equal to 25."

Answered by AI

What are the central aims of this investigation?

"This trial, with a postpartum monitoring period of one month, aims to measure the infant BMI z-score. Additionally, it will evaluate 6 month Infant Veggie Meter (Raman spectroscopy Skin Carotenoid assessments), 6 month Infant Blood Biomarkers (Multiplex analyses of inflammatory markers IL6) and 1 month Postpartum Maternal Body Fat% (Estimated body fat %)."

Answered by AI

Does this research encompass minors within the scope of its criteria?

"The age range required for enrollment in this experiment is from 18 to 40."

Answered by AI

Are there any in-progress openings for this scientific investigation?

"This experiment is currently seeking participants according to the information posted on clinicaltrials.gov; it was initially listed on October 18th 2021, and most recently updated July 15th 2022."

Answered by AI

How many participants can the trial accommodate in total?

"Affirmative. Clinicaltrials.gov states that the medical experiment, which was initially published on October 18th 2021, is currently recruiting volunteers. Three hundred test subjects are required from a single location for continued study of this medication."

Answered by AI
~162 spots leftby Jan 2027