Prenatal Exercise for Childhood Obesity

Overseen By Jameta Edwards

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: East Carolina University

Must not be taking: Oral hypertensive, Insulin

Disqualifiers: Diabetes, Hypertension, Thyroid disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 27 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall objective of this proposal is to conduct a longitudinal prospective study of overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims: Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB 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 \[HR\], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB 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 OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB 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 study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, such as oral hypertensive drugs and insulin, so you may need to stop taking these if you are currently using them.

Is prenatal exercise safe for pregnant women and their babies?

Research shows that prenatal exercise is generally safe for pregnant women and their babies, with a low risk of serious adverse events. It can improve maternal health and fetal outcomes, such as maintaining healthy weight gain and preventing excessive fat accumulation in newborns. ^{1 2 3 4 5}

How does the treatment of prenatal exercise differ from other treatments for childhood obesity?

Prenatal exercise, which includes aerobic and resistance exercises, is unique because it targets childhood obesity by potentially influencing the child's health before birth, unlike other treatments that focus on modifying diet and activity levels after birth. This approach may help reduce obesity-related risk factors early on, promoting better long-term health outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Exercise Modes, Physical Activity, Aerobic Exercise, Resistance Exercise, Aerobic+Resistance Exercise for childhood obesity?

Research shows that aerobic exercise and a combination of aerobic and resistance exercises can improve cardiovascular health and reduce body weight, body mass index, and fat mass in children with obesity. These exercises have been associated with better health outcomes, making them effective treatments for managing childhood obesity. ^{8 9 11 12 13}

Who Is on the Research Team?

Linda E May, PhD

Principal Investigator

PI

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Pregnancy: Singleton; ≤ 16 weeks gestation

BMI between ≥ 25

Clearance by Obstetric provider for exercise

Exclusion Criteria

BMI <25

Unable or Unwilling to provide consent

I have a condition like HIV, cancer, diabetes, high blood pressure, or thyroid issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant women participate in exercise interventions (aerobic, resistance, or combination) or no exercise from approximately 13 to 40 weeks of gestation

27 weeks

Weekly exercise sessions

Follow-up

Participants and their infants are monitored for cardiometabolic health outcomes at 1, 6, and 12 months postpartum

12 months

3 visits (in-person) at 1, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Modes

Trial Overview 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.

How Is the Trial Designed?

Group I: Resistance Exercise (RE) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Published Research Related to This Trial

Aerobic exercise significantly improved 83.3% of cardiovascular disease (CVD) risk factors in children and adolescents with obesity, based on a review of 39 studies involving 1548 participants.

Combined aerobic and strength training also showed benefits, improving 62.5% of CVD risk factors, but the overall strength of evidence was low to moderate, indicating a need for more rigorous future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Cardiovascular Disease Risk Factors in Children and Adolescents With Obesity: A Systematic Review With Meta-Analysis of Randomized Controlled Trials. Kelley, GA., Kelley, KS., Pate, RR.[2023]

A systematic review of 12 trials involving 555 obese children and adolescents found that combining aerobic and resistance exercise led to greater improvements in body mass, fat mass, and low-density lipoprotein cholesterol compared to aerobic exercise alone.

The concurrent exercise program also resulted in increased lean body mass and higher levels of adiponectin, with more significant benefits observed in programs lasting longer than 24 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent aerobic plus resistance exercise versus aerobic exercise alone to improve health outcomes in paediatric obesity: a systematic review and meta-analysis. García-Hermoso, A., Ramírez-Vélez, R., Ramírez-Campillo, R., et al.[2022]

A 16-week multimodal intervention combining enjoyable physical activities and nutritional counseling significantly improved health outcomes in 18 obese children, including better body composition and metabolic profiles.

The program achieved over 80% attendance and enhanced physical fitness, demonstrating that a fun and respectful approach to exercise can effectively combat childhood obesity without strict caloric restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent Exercise Training Combined with Nutritional Counselling Improves Physical Function, Biochemical and Anthropometric Profiles in Obese Children: A Pilot Study. Cordellat, A., Padilla, B., Grattarola, P., et al.[2021]

In a study involving 80 obese children, a 40-minute treadmill training session at 100% of the first ventilatory threshold (VT1) significantly improved cardiovascular risk factors, including a notable drop in total cholesterol and low-density lipoprotein levels.

The same group also showed a significant increase in maximum oxygen uptake (VO2max) and a decrease in perceived exertion (RPE), highlighting that longer and higher intensity exercise is more effective for improving health outcomes in obese children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk profile, oxygen uptake, and perceived exertion rate in children with obesity: the interactive effect of exercise intensity and duration. Elnaggar, RK., Elshazly, FA., Abdelbasset, WK., et al.[2022]

A meta-analysis of 9 randomized controlled trials involving 365 overweight and obese youth showed that combining aerobic and resistance exercise for 8-24 weeks significantly reduced body weight, body mass index, and fat mass.

Longer exercise sessions of at least 60 minutes led to even greater reductions in body weight and fat mass, highlighting the importance of exercise duration in achieving effective results in pediatric obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Plus Resistance Exercise on Body Composition Related Variables in Pediatric Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. García-Hermoso, A., Sánchez-López, M., Martínez-Vizcaíno, V.[2018]

A systematic review of 61 randomized controlled trials found strong evidence that combined aerobic and resistance training during pregnancy significantly improves maternal cardiorespiratory fitness and helps prevent urinary incontinence.

The combination of aerobic and resistance exercises is identified as the most beneficial exercise modality for maternal health during pregnancy, while other exercise interventions showed weak or insufficient evidence for their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of aerobic or resistance training during pregnancy on maternal health and perinatal outcomes: A systematic review. Perales, M., Santos-Lozano, A., Ruiz, JR., et al.[2022]

In a study of 82 pregnant women, those who participated in a supervised exercise program gained significantly less weight during pregnancy compared to those who received standard prenatal care, indicating that exercise can help manage weight in overweight pregnant women.

The exercise program did not lead to adverse effects on perinatal outcomes, blood pressure, or quality of life, suggesting it is a safe intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. Nascimento, SL., Surita, FG., Parpinelli, MÂ., et al.[2022]

A systematic review of 74 studies involving 3766 pregnant women found that the serious adverse event rate during exercise is very low, at 1.4 per 10,000 hours of exercise, indicating that exercise is generally safe for healthy pregnant women.

Even when including mild adverse events and fetal heart rate changes, the overall risk remains low at 6.8 per 10,000 hours, suggesting that both previously inactive and active women can safely engage in regular physical activity during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: pregnancy. Charlesworth, S., Foulds, HJ., Burr, JF., et al.[2018]

Prenatal exercise is a safe and effective intervention that promotes both maternal and fetal health, with recommendations of at least 150 minutes of moderate-intensity exercise per week during pregnancy.

Engaging in prenatal exercise helps maintain healthy weight gain, improves maternal glucose control, and enhances placental efficiency, ultimately preventing excessive fat accumulation in newborns and supporting fetal muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention to optimize fetal weight. Reyes, LM., Davenport, MH.[2019]

A 2.5-year study involving 141 low-risk pregnant women found that engaging in aerobic exercise during pregnancy did not increase risks for neonatal morbidity or obstetric complications, indicating that exercise is safe for both mother and baby.

The study demonstrated that pregnant women who exercised maintained or improved their aerobic fitness levels, with significant training effects observed, suggesting that regular aerobic activity can be beneficial during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise in pregnancy. Kulpa, PJ., White, BM., Visscher, R.[2019]

Pediatric obesity rates have more than doubled in recent decades, leading to increased cardiovascular disease (CVD) risk factors such as insulin resistance and arterial stiffness, highlighting the urgent need for early intervention.

Exercise interventions, particularly those combining aerobic and resistance training, are effective strategies to reduce CVD risk factors in obese children and adolescents, emphasizing the importance of long-term adherence and fat mass reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impacts of exercise on pediatric obesity. Headid Iii, RJ., Park, SY.[2021]

In a study of 139 obese adolescents over one year, combining aerobic training with resistance training (AT + RT) was more effective than aerobic training alone (AT) in reducing body fat and improving cardiovascular risk factors.

The AT + RT group showed significant improvements in metabolic markers, including lower LDL cholesterol and better leptin/adiponectin ratios, indicating enhanced management of obesity-related inflammation and cardiovascular risk in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic plus resistance training was more effective in improving the visceral adiposity, metabolic profile and inflammatory markers than aerobic training in obese adolescents. Dâmaso, AR., da Silveira Campos, RM., Caranti, DA., et al.[2015]

Increasing physical activity is essential for preventing and treating childhood obesity, as it enhances fat oxidation in both active and resting states.

Reducing sedentary behavior and promoting light to moderate physical activities, especially in older children and adolescents, can significantly aid in weight control, although more research is needed to develop effective programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in the prevention and treatment of childhood obesity: physio-pathologic evidence and promising experiences. Maffeis, C.[2009]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Exercise and Cardiovascular Disease Risk Factors in Children and Adolescents With Obesity: A Systematic Review With Meta-Analysis of Randomized Controlled Trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Concurrent aerobic plus resistance exercise versus aerobic exercise alone to improve health outcomes in paediatric obesity: a systematic review and meta-analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Multicomponent Exercise Training Combined with Nutritional Counselling Improves Physical Function, Biochemical and Anthropometric Profiles in Obese Children: A Pilot Study. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Cardiovascular risk profile, oxygen uptake, and perceived exertion rate in children with obesity: the interactive effect of exercise intensity and duration. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Plus Resistance Exercise on Body Composition Related Variables in Pediatric Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Benefits of aerobic or resistance training during pregnancy on maternal health and perinatal outcomes: A systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: pregnancy. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention to optimize fetal weight. [2019]

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Aerobic exercise in pregnancy. [2019]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

The impacts of exercise on pediatric obesity. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Aerobic plus resistance training was more effective in improving the visceral adiposity, metabolic profile and inflammatory markers than aerobic training in obese adolescents. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Physical activity in the prevention and treatment of childhood obesity: physio-pathologic evidence and promising experiences. [2009]